Director, Clinical Resume Samples

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J Buckridge

Jedediah

Buckridge

54309 Langworth Station

New York

+1 (555) 826 6347

54309 Langworth Station

New York

Phone

p +1 (555) 826 6347

Experience Experience

Dallas, TX

Director, Clinical Affairs

Dallas, TX

Monahan, Beier and Stiedemann

Dallas, TX

Director, Clinical Affairs

Develop effective and collaborative working relationships environment amongst internal/external team members and vendors
Provide project/study management and monitoring plans for projects
Lead and ensure that all Clinical Research strategy & clinical Plans within the responsible Business Groups are developed and managed effectively in terms of
Provide overall management for clinical trials as assigned
Develop standard safety testing protocols that align with corporate objectives (i.e. non-acnegenicity, non-comedogenicity, cumulative Irritation)
Develop compelling, creative, innovative, and differentiated clinical and consumer product claims and testing protocols
Participates in hiring, goal-setting, performance evaluations, termination, promotion and merit decisions

Phoenix, AZ

Director, Clinical Services

Phoenix, AZ

Mertz and Sons

Phoenix, AZ

Director, Clinical Services

Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
Enhances and develops clinical delivery systems
Works within the Post-acute services framework by optimizing Long term care and Swing bed services as well as wound Care
Day-to-day management of clinical operations and clinical client relationship, including evaluation of current priorities, allocation of resources to support daily and strategic objectives, and communication of client expectations to the account management and operations teams
Lead using a performance management and development process that provides an overall context and framework to encourage employee contribution and includes goal setting, feedback, and performance development planning
Develop annual administrative budgets and lead, support and collaborate in the compilation and execution of auditing functions and preparedness
Develop, implement, and maintain operating policies, procedures, and performance standards

present

New York, NY

Director, Clinical Biospecimen Management

New York, NY

Dietrich, Crona and Leannon

present

New York, NY

Director, Clinical Biospecimen Management

present

Provide strategic guidance for Biospecimen Management Plans developed for active studies
Establish and approve key policies and procedures for the management and approval of Clinical biospecimen use at BioMarin
Provide overall BioMarin guidance on the biospecimen management lifecycle and authorization process
Responsible for the development of department strategy, goals, vision, core competencies, resourcing, staff management, budget, etc
Ensure effective oversight, training, and guidance is provided to Biospecimen planners involved in assigned portfolio of programs
Oversee service provider relationships for all outsourced activities for CBM
Communicate risks and mitigation strategies relating to scope, timelines, resources and quality to Development Sciences Sr. Leadership in a timely manner

Education Education

Bachelor’s Degree in Nursing

Seton Hall University

Bachelor’s Degree in Nursing

Skills Skills

Strong management skills with the ability to lead cohesive and productive teams
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact
Ability to represent the Company at professional and business functions in a competent manner
Demonstrated ability to build collaborative relationships with key internal and external stakeholders
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships
Ability to lead and influence through direct and indirect resources to shape organization
Demonstrated ability to manage multiple studies, staff and company initiatives effectively
Practical experience with clinical research studies, in the cardiovascular, peripheral vascular or electrophysiology medical device applications in a sponsor company, or equivalent
Demonstrated ability to manage multiple projects, staff and company initiatives effectively
Comprehensive understanding of applicable clinical research regulations in multiple regions

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Associate Director, Clinical Reimbursement Resume Examples & Samples

Updating and maintaining coding policies
Maintaining coders schedules to ensure appropriate coverage in all areas
Coordinating work assignment to all coders
Monitoring DNFB and OPX daily in order to minimize number and value of unbilled accounts
Daily pre-bill DRG validation, addressing coding errors with coders, educating them and monitoring compliance
Coordinating post-discharge coding query process
Monitoring compliance and results
Educating physicians on documentation requirements and the importance based on coding query results
Working in conjunction with CDI team on documentation improvement process
Cross training outpatient coders on inpatient coding
Coordinating and assisting coders with ICD10 training. Conduct ICD 10 physician education
Assisting Business Office with researching, analyzing, resolving claim issues
IPRO/RAC DRG appeal management
RHIA, RHIT, or CCS certification required
BS or AS in Business of Health related field
Excellent communication and written skills

Director, Clinical Enrollment & Operations Resume Examples & Samples

Interface cross-functionally, at all levels of the organization, to ensure programs, services and supplies are delivered to both internal and external stakeholders
Provide technical and procedural advice in a broad range of operational areas with the ability to develop, maintain and supervise accountability systems for programs, services and logistics management
Recruit, retain and develop talent, facilitating extraordinary associate engagement
Participate in an integrated fashion with other areas of the Humana organization
Bachelor’s Degree in Business, Finance or related field
Prior work experience in the health or social service industry
A minimum of 5 years of proven success directing and leading large teams preferably in a call center environment
Experience with policy development, project management and strategic development
Proven ability to create and implement strategic plans around telephonic and enrollment programs and processes
Proficiency in analyzing and interpreting financial trends
Formal continuous and process improvement experience with proven Project Management experience from a member experience lense
Clinician experience
Six Sigma certification

Director, Clinical Imaging Resume Examples & Samples

5+ years Radiology/imaging management experience preferred (managing staff and workflows); ideally, in an imaging setting in an academic medical center with multiple sites of service, residents, and large daily volumes of procedures
Work experience or solid understanding of operations in a clinical setting or discipline (e.g. Nursing, Pharmacy, Laboratory, Radiology, etc.)
Proven project management skills with specific experience leading system selection and implementation
Clinical application implementation and support experience preferred

Senior Director Clinical R&D Biosurgery Resume Examples & Samples

The Sr. Director Clinical R&D Biosurgery will be serving as the CR&D representative on the platform governance / innovation committees, provide critical and technical expertise in portfolio prioritization
Provide critical technical and strategic expertise in the assessment of NBD projects and opportunities identified through the Innovation Centers, including potential investment and acquisition opportunities, to shape business strategy
Build and develop talent to provide deep strategic and scientific clinical research capability across assigned platforms
Lead team of clinical research professionals to develop and deliver appropriate Global Evidence Generation and Dissemination Strategies (EGS / EDS) to support New Product Development and Life-Cycle Management within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, G-HEMA/EBM, R&D, etc), ensuring cross- functional alignment
Accountable for overall delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP)
Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs
Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts
Lead clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections
Accountable for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations,
Foster strong relationships with external stakeholders to shape and influence relevant policies,
Partner with EBM/G-HEMA and Medical Affairs to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
Comprehensive understanding of clinical trial regulations across multiple regions
Bachelor’s degree in Biological Science or related discipline with a minimum of 12 years related scientific technical experience with 8 years Clinical Research Management experience OR PhD or Masters in Biological Science or related discipline with 10 years related scientific / technical experience with 6 years Clinical Research Management experience
People management experience is required for this role
Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across projects is required
Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
Experience in effective management of platform budget processes is required
This position requires 25% international and domestic travel

Director, Clinical Trial Management Resume Examples & Samples

Collaborate with Clinical R&D Franchise Leaders to identify and ensure global strategies, resources and accountabilities are in place to achieve rapid, cost-effective and well-executed clinical studies, for the supported franchises delivering high quality clinical data to support Regulatory ,Market Access and reimbursement needs
Deliver clinical studies within clinical / surgical research setting, on time, within budget and in compliance to SOPs and all applicable regulations and requirements and manage all clinical operations activities for assigned franchises, coordinating with EMEA and APAC leaders to insure appropriate resources , timelines and budget are in place for regional sites/activities
Define and administer project timelines and budgets in collaboration with business unit and regional representatives. Allocate resources according to budget and timeline requirements maintaining optimal efficiency and cost effectiveness
A minimum of Bachelor’s Degree with 12 years of relevant experience OR a Master’s with 10 years’ Experience OR a PhD/MD/PharmD with 8 years of relevant experience is required
Experience in Medical Device industry is strongly preferred
IND/IDE experience is strongly preferred
Industry certifications (i.e., CCRA, RAC, CDE) is preferred
Experience in Orthopedics and/or Neurovascular studies is strongly preferred
Clinical Research Organization (CRO) management experience is strongly preferred

Associate Director, Clinical Biostatistics Resume Examples & Samples

Take the lead in working with the team in designing clinical studies, leading/authoring the statistical analysis plan and provide statistical input to the clinical study report
Serve as the primary contact to outside investigators in the preparation of scientific presentation and manuscripts. They will take a leadership role in process improvement, training, standards development or enhancing statistical technical expertise
Be responsible to liaise with other statisticians within the organization, building working relationships with therapeutic area leaders, internal SAS programmers, clinical trial managers, regulatory affairs, medical writing, and other disciplines as needed
Work with external partners including key opinion leaders, may work with external regulatory agencies and advisory committees, and contract research organizations
A PhD in Statistics or related field with at least 6 years of relevant clinical trials experience, or a Master’s in Statistics or related field with 8 years of experience is required
Experience and knowledge of Good Clinical Practices and Health Authority requirements for clinical drug development is required
Experience influencing clinical development programs is preferred
Experience with Adaptive Designs, Modeling, and Simulations is required. Proficiency with statistical software such as SAS and R is required
Demonstrated experience managing workflow in a cross functional matrix organization is required
Excellent verbal and written communication skills, including formal presentation skills, are required
Experience presenting to technical and lay groups at public meetings is required
Written skills as evidenced by publication and journal articles are preferred
Ability to successfully multi-task and work independently, under minimal supervision, and excellent teamwork skills are required
Ability to influence, negotiate and communicate with both internal and external customers is required

Scientific Director, Clinical Pharnacology Resume Examples & Samples

Responsible for designing, developing and implementing clinical pharmacology plans and strategies for supporting end-to-end projects initiated by China R&D. Responsible for the design of studies to evaluate candidate drugs’ pharmarcokinetics (PK) and pharmacodynamics (PD) clinically
Responsible for providing Clin Pharm contributions to China regulatory submissions and approvals: Designing & conducting bridging China PKPD studies, providing strategic supports in liaison with global Clin Pharm
Responsible for delivering quantitative pharmacology and modeling & simulation supports to discovery of both small molecules & biologics, early to late clinical development, and post-marketing development in China R&D organization. Work collaboratively with key functional partners and apply quantitative ClinPharm tools to guide NME selection, dose / dose regimen selection, predict clinical response and study outcomes, and to optimize study design
With minimal guidance from ClinPharm Head, provide appropriate dosing recommendations for special populations (eg, drug interaction, food effect, pharmacogenomic effect, pediatric, elderly)
Has overall scientific accountability for ClinPharm studies and ClinPharm components of other studies
With minimal guidance from ClinPharm Head, prepare ClinPharm contributions to regulatory documents including IBs, End of Phase 2a / 2 meetings, NDA / MAA submissions, postapproval filings, and responses to regulatory questions
As appropriate, represent ClinPharm at relevant regulatory meetings (eg, End of Phase 2a / 2, pre-NDA / MAA, Advisory Committee meetings)
Responsible for the consistency, quality, compliance, and timeliness of clinical PK and PK/PD input into Phase I to III protocols, data analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and processes
Provide leadership, direction, and training to other clinical pharmacology staff supporting the program, including liaison with CRO counterparts, as applicable
Serves as member of the Clinical Development Team and Compound Development Team, where appropiate, for all clinical PK and PK/PD aspects of development projects and programs
Contributes to the identification, characterization, and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies
Assist in evaluation of in-licensing opportunities for clinical PK and PK/PD components
Present and / or publish scientific data at conferences and in peer-reviewed journals
Stay abreast of new emerging technologies in relevant scientific fields
Liaise with key functional partners to provide product differentiation strategies based on a compound's key ClinPharm attributes
Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity
MS or Pharm D degrees with 7 years of pharmaceutical development experience
PhD or equivalent degrees with 5 years of pharmaceutical development experience
Demonstrated competency in PK/PD modeling & simulation
Experience in the use of WinNonlin, NONMEM, R or S-plus, database management, or related scientific software
Working knowledge of Clinical Pharmacology, PK/PD modeling concepts and basic statistics
Good understanding of clinical drug development and the overall pharmaceutical R&D process
Working knowledge of US, European, and Asian regulatory requirements and guidelines
Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
Ability to lead and / or oversee multiple smaller ClinPharm programs
Has established a good level of expertise and scientific reputation through publications and presentations
Fluent in written and spoken English
Good written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication)
Ability to build and maintain effective working relationships inside and outside the department; strong aptitude for working in a cross-functional team environment; demonstrates commitment to team's expectations and decisions (building strategic working relationships)
Ability to multi-task, prioritize assignments, and work under pressure, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organization, managing the job)
Assume responsibility and accountability for successfully completing assignments or tasks, proactively taking action to accomplish objectives, and setting high standards of performance (delivery of results)
Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency; exercises good judgment in assessing situations and deciding next steps (decision making)
Good sense of cultural sensitivity and diversity (cultural diversity)
Actively identify new areas for learning and application to the job (continuous learning)
Self-motivated and able to work independently with minimal supervision (personal accountability)
Understands the broader development organization
Ability to inspire, motivate, and provide effective leadership to team members
Courage to stand alone on ideas and opinions which differ from others; takes risks where necessary (prudent risk taking)

Associate Director, Clinical Services Resume Examples & Samples

Earned doctoral degree in clinical or counseling psychology
Demonstrated knowledge, ability and experience effectively working with diverse populations
At least two years licensure as a psychologist
Demonstrated knowledge and experience in administration of service(s) within a mental health environment; and
Demonstrated knowledge and experience providing clinical supervision

Global Director Clinical Ancillary Management Resume Examples & Samples

Develop demand management processes and systems to ensure availability of ancillary materials does not impact patient dosing
Provides effective leadership to meet or exceed the financial goals of Fisher Clinical Services Clinical Ancillary Management service line
Develops sales strategy to expand customer base and develop new relationships within Clinical Operations groups
Oversees dedicated sourcing resources and create strategies to ensure procurement of ancillaries can be successfully executed globally
Creates and manages global CAM sourcing expertise to deliver the best possible strategies to drive continuity of supply to the patients we serve
Ensure organizational structures, processes and systems are scalable to support a global service line
Works with the global FCS GM’s, Fisher BioServices, PSI and other Thermo Fisher Scientific units to collaborate on the over-all CAM strategy and solutions that best meet the client’s needs
Develops and executes sales strategies designed to support the attainment of revenue goals
Reviews sales performance against plans and performance standards. Interprets results, communicates to subordinates and approves changes in direction of plans
Directs monitors and effectively appraises the performance of all direct reports providing training and development activities where appropriate
Model and foster excellent customer service (internal & external) in all functions and responsibilities
Demonstrates and promotes the company and Division’s mission and vision
Generates and Delivers Performance Evaluations on time
Holds staff accountable for their ongoing performance to specified standards
Develops Global Ancillary service line budget and manage to those commitments
Identifies resource needs and effectively advocates for approval of needed investments
Builds relationships across related TMO divisions to maximize sourcing capabilities within service lines
Other responsibilities as assigned by manager
At least 15 years of experience with in the life sciences industry
Familiarity with clinical research, clinical operations, clinical ancillary experience, logistics and sourcing
Experience managing individuals directly or indirectly a must
Experience in managing budgets and accountability for delivering financial targets required
5 years of experience in a customer facing role-required
Willing to travel at least 20-30% of the time
Proven track record of success
Minimal requirements include a BS/BA or equivalent in business or life sciences
Direct experience in the CRO industry with drug development and or clinical supply services preferred
Experience in managing global departments and individuals preferred

Director, Clinical Transformation Resume Examples & Samples

Serve as a care redesign expert at Flatiron
Define Flatiron’s strategy for supporting practices with clinical transformation, and execute on it
Work closely with practice administrators and medical directors to guide them in transforming their clinics in new care delivery models
Interact with potential Flatiron clients, supporting them in their questions on how Flatiron data & technology can help them achieve their care redesign goals
Strategize about new ways to leverage existing Flatiron data as well as expand the existing data-set to improve practices’ care redesign initiatives for value-based care
Evaluate best practices for value-based care and the impact of Flatiron products on value-based care outcomes for both internal analyses and publication
Partner with a multi-disciplinary team at Flatiron to define the strategy and execute on health services research related to care redesign
Remain up-to-date on emerging trends in healthcare delivery and educate other internal and external stakeholders
Participate in other Flatiron initiatives as a member of Flatiron’s oncology team

Senior Director, Clinical Business Enablement Resume Examples & Samples

Program Management: Provide support to internal clients / leadership to enable successful business operations including program risk identification and remediation; drive process improvement and standardization through collaboration with impacted business partners. Lead the development of operational review / update presentations
Alignment: Lead the transition of human capital from one functional area to another with engagement from leadership, business partners, human capital partners and finance. Work includes facilitation of deep dive discovery, identification of similar work processes, coordinate approvals for identified changes, solution for variances and manage the corresponding communication plan. Coordinate staffing analysis and drive approvals from finance, business, and segment owners
Expansion: Led the effort, strategy development, and implementation with Global Sourcing operational teams to support Clinical Services international structure
Compliance - Focused: Work with stakeholders to minimize compliance risks. Collaborate to identify and improve processes to reduce risk. Lead crucial conversations and keep the project team engaged and focused on targeted outcomes
Provide Strong Leadership, Judgment and strategy for alignment and expansion initiatives
Lead in a matrix organization by effectively maintaining and building relationships across operational and functional teams
Create a team oriented work climate that enables professional development and encourages creative solutions and strategies, establishes collaboration and emphasizes quality, compliance and cost effectiveness
Obtain Senior Management Engagement in the ideation, planning and execution process
Define and implement tools and methods to be used for Project / Program Management for all initiatives within a program
Facilitate Development and obtain Senior leadership approval for Program Roadmap and Timelines
Manage Program Roadmaps and Timelines
Resolve Variance from Program execution plans
Develop comprehensive and compelling cost benefit analysis to support staffing requests
Work with Operational leaders and global sourcing partners to develop and implement new programs and cost saving initiatives
Appropriately prioritize initiatives within program based on cost benefit, compliance and efficiency
Require project realization planning and execution for all initiatives
Require quality assurance plans and methods are implemented for all initiatives
Facilitate Risk Management decisions required from Senior Management
Monitor and communicate risk management status and contingency implementation to Senior Management
Develop and Manage Program Communication Plan
10+ years of project management experience within a matrix organization (healthcare experience preferred)
5+ years of experience in successfully managing large - scale projects - including integrated multiple business areas
5+ years working with enterprise and Business Segment objectives
Experience with executive communications - ability to effectively share vision
5+ years of experience coaching and managing individuals
Ability to manage multiple tasks and priorities in a matrix environment, strong problem solving skills and attention to detail
Proven organizational skills with ability to be flexible and drive work forward when faced with ambiguity
Energy, motivation, and commitment to drive to results in a challenging, fast-paced environment
Demonstrated ability to meet commitments, build consensus, negotiate resolutions, and garner respect from other teams
Excellent oral, written and interpersonal communication with both technical and business audiences
Solid interpersonal skills, passion around facilitation, empowerment, and servant leadership
Ability to build trust relationships with Customers
Ability to effectively communicate with Sr. Management on strategic Issues
Proven ability to influence course of action with diplomacy and tact when others are directly accountable for outcomes
Diplomatic with strong negotiation and conflict resolution skills
Demonstrated ability to manage and develop people while prioritizing deliverables when faced with competing priorities
Passion for customers and a demonstrated focus on customer experience

Senior Director Clinical Quality Resume Examples & Samples

Works to coordinate the work within the QMP Centers of Excellence for: HEDIS Data Collection, Data Analytics and Reporting, Accreditation, Member Surveys, Regulatory Adherence, and Member Activation and Engagement; utilizing the expertise, standard process, and capabilities of these areas to enhance quality program performance of the plan
Collaborates across business segments to attain or maintain the Plan’s compliance with accreditation standards and contractual requirements as they apply to quality
Oversees and insures the creation, integration, maintenance, approval, and submission of the trilogy document, including but not limited to Quality Program Description, Work Plan, Evaluation, and Program Policies and Procedures
Oversees and insures the creation and submission of reports to meet state contractual requirements including Performance Improvement projects (PIPs)
Insures and oversees Health Plan Quality Management /committee structure and integrated quality oversight processes
Travel up to 25%
BS / BA in Healthcare
8+ years of experience in leading an integrated and progressive quality organization, preferably within health care industry
8+ years of significant leadership and managerial role within large, global, matrixed, complex organization
Demonstrated ability to develop, execute and improve Clinical Programs across a large or multiple business units
Proven record in driving substantial quantifiable operational improvements
Demonstrated ability and success in deploying quality initiatives that rendered an increase in HEDIS scores
Medicaid Accreditation experience
Strong outcome assessment skills and experience
Demonstrated ability to apply process methods and tools to business challenges
Strong leader who can work with the team and communicate across and upward effectively
Strong, independent decision maker and risk taker
Strong process and project management skills
Demonstrated leadership ability, including building and driving high performance teams
Comprehensive understanding of functional areas and the impact in performance and performance measurement of quality
Master’s or Doctorate degree preferred
Public Sector experience
Understanding of the financial principles and operations of the business and able to drive profitability
Commitment to anticipating, understanding and meeting the needs of internal and external customers
Business focus - understanding of company's vision mission, values and strategy to achieve long- and short-term goals
Model ethics and integrity
Empowers and motivates others
Serves as a strong coach and fosters career development of quality staff
Expert knowledge of the managed care / health insurance industry, products and services (preferred)

Director Clinical & Hedis Quality Solutions Resume Examples & Samples

Take ownership of the client account from pre-sales / sales through transition to implementation
Set the strategy & agenda for HEDIS products & services
Develop service offering and add-on components to increase value of the solution
Coordination with Client Management team to ensure alignment on client strategy
Experience being in a senior leadership role in Quality (e.g. Director of HEDIS / Stars)
Demonstrated ability to problem solve
Have expertise in health plan operations, especially around Stars
Expert level understanding of Quality Measurement and Improvement
Ability to support and service new product development

Senior Director, Clinical Analytic Outcomes Resume Examples & Samples

Provides oversight and guidance in the resolution of complex issues utilizing available resources and expertise in support of OptumRx’s clinical analytics objectives
Ability to influence internal and external constituents and manage potential conflicts while gaining buy-in for a coordinated strategy
Ensure integrity, accuracy and timelines of analysis. Develop documents that explain methodologies in evaluating healthcare
Master's degree in clinical sciences, pharmacy or quantitative based field, such as: Statistics, Mathematics, Pharmacy, Public Health, Decision Science
10+ years of analytics experience with healthcare data (pharmacy and/or medical administrative claims analytics)
5+ years of experience developing and managing quantitative projects
3+ years of experience that demonstrated analytical ability to derive actionable insights from data findings
Demonstrated experience either with writing SQL queries, Strong ACCESS or Expert at Excel
2+ years of experience with presenting in person at conferences, key note presentations, or large in-person client audiences
Experience in communicating to a C-suite audience and ability to drive consensus on complex, controversial issues
Demonstrated experience in planning and execution of complex reporting and analytic projects
Excellent leadership skills, requires minimum 5 years direct management experience of healthcare analytic team
Highly effective written and verbal communication skills, including the ability to translate analytic concepts, approaches and results for executive or lay audiences
Analytic interpersonal skills with an ability to communicate to small and/or large audiences (both internal and external to OptumRx)
PBM or Managed Care Organization experience
MBA degree
Pharmacist degree
2 years of benefits consulting
SAS or other statistical analytic tools experience
Demonstrated analytic skills and creativity to quickly integrate information and develop business proposals for new initiatives
Strong track record publishing in peer-reviewed journals

Regional Director Clinical Transformation CCO West Resume Examples & Samples

The Regional Director develops policies, procedures, and guidelines for medical and clinical operations
Reviews / approve policy and process changes
Evaluates regulatory changes and determine steps needed to implement in programs
Develops medical and clinical operations program goals
Implements opportunities to support growth of medical and clinical operations programs
Oversees / navigates technology and software applications utilized in the delivery of CCO programs
Oversees management / service delivery systems utilized in member care
Contributes to and implements a business continuity plan to minimize interruptions to the business
Interprets compliance / clinical / medical reports
Evaluates compliance with Federal, State, and Local regulatory and organizational guidelines
Evaluates programs and services against state performance standards
Evaluate programs and services against CMS contractual requirements
Oversee monitoring and operations against relevant guidelines and standards
Implements continuous process improvement activities to ensure care is optimized
Measures employee / provider performance against internal procedures and protocols
Ensures Health Homes address gaps in performance against internal procedures and protocols
Develops and communicates performance metrics and expectations to Health Homes Directs Clinical Operations data collection and measurement of outcomes
Applies metrics to evaluate services, employee performance, and program outcomes
Read and interpret reports (e.g., performance, service)
Identifies causes of performance deficiencies and determine appropriate follow up actions with team
Drives team implementation of best practices and standards
Develops operational budgets for medical and clinical operations
Evaluates staffing ratios, stratification of care, agency operations, to effectively manage business costs
Read financial reports, identifies reasons for financial performance gaps, and identify opportunities for improved financial performance and enhanced return on investment
Collects and reviews data to evaluate financial outcomes of programs and services
Conducts cost / benefit analysis on programs to drive efficiencies
Conduct competitive analysis and identify opportunities to enhance financial viability
Proposes and obtains approval for capital expenditures for needed medical and clinical operations
Collaborates with national, regional and health plan leaders and clinical program leaders to identify and effectively promote best in class strategies, and supports national clinical leaders in program development
Results driven leader with five years’ experience leading population health strategies in Medicare and Commercial populations
Strong measurement and analytic focus
Record of success in driving affordability initiatives and inspiring teams to achieve process improvement
Experienced implementing strategies to integrate medical, behavioral and social support for complex patients
Experience leading Medicare STARS quality improvement initiatives
Effective in relationship building in a matrix management environment and negotiating solutions
Exceptional oral and written and presentation skills
Knowledge and experience implementing evidence based Care Transitions programs
Strong quality management experience including PDSA initiatives
Ability to organize and thrive in a fast - paced environment
Ability to travel in region 25%
Master’s degree in epidemiology or public health
Experience implementing community based collaborative
Knowledge and experienced of CMS Innovation strategies and service delivery models
Knowledge of best practices in Medicaid nationally
Experience implementing behavioral health quality initiatives

Director, Clinical Programs Resume Examples & Samples

Ensure on time execution of THV product platform U.S. clinical trials and related activities are achieved per annual operating plan in accordance with global clinical processes, regulations and good clinical practices
Ensure all safety surveillance and monitoring, identification and reporting of adverse events and device-related complications are completed in accordance with regulatory and corporate/divisional requirements. Follow up with U.S. Regulatory Affairs as necessary
Ensure the management and maintenance of site and internal research documentation are handled in accordance with established Standard Operating Procedures (SOPs) and regional research directives and guidelines for agency/internal auditing
Oversees the preparation, documentation, monitoring and distribution of contract obligations including financial obligations. Ensures that research contract obligations are met in a timely manner
Ensures the proper management and training of all staff and assigned CRO personnel, Associate/ Clinical Research Specialists working on Edwards’ research programs
Manages the preparation of clinical data presentations of assigned product platform for Regulatory submissions, conferences and study meetings (Executive Committees, DSMB, CEC, Steering Committees) for accuracy and relevancy
Mentor Clinical Project Managers on appropriate tools and techniques for achieving project milestones and timelines and working with Core Teams and advancing their career development
Computer skills – Microsoft Office (Word, Excel, Access, PowerPoint), Internet
Thorough conscientious and results oriented working style
Independent judgment skills & action orientation for obtaining required results
Bachelor’s degree in medical or biological sciences required; advanced degree preferred
Advanced knowledge of international regulations of Good Clinical Practice (GCP), experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research
Project management experience
Management of clinical trial steering committees
Supervision and mentoring of subordinates

Director, Clinical & Vocational Ops Resume Examples & Samples

Analyzes trends in utilization of clinical and vocational resources to ensure appropriate use of resources to maximize claim outcomes
Develops and executes complex clinical and vocational initiatives, which significantly impact the success of claims handling, enhance the customer experience, and successfully meet the annual business operating priorities
Ensures long term success and direction of Clinical and Vocational Departments
Leads discussions with internal stakeholders to develop best practices in medical and vocational support to meet business objectives
Oversees the design and delivery of medical training for the entire claims department, utilizing internal resources to provide stretch assignments
Partners with claims leaders to ensure smooth workflow as well as quality and consistency of claims practices
Partners with training to develop ongoing training materials with the most current medical information
Provides direction for all clinical and vocational department initiatives and Vendor Management
Provides leadership and medical guidance in the application of medical impairment risk and functional capacity in disability insurance cases
Provides oversight and workload management for internal physician consultants
7+ Years medical experience in claims or a combination of medical experience with a minimum of 5 years clinical experience; including 3+ years managerial and/or demonstrated leadership experience.(Required)
4 Year/Bachelors Degree or equivalent work experience (4 years of experience in lieu of Bachelors) in in Registered Nursing or Vocational Rehabilitation (Minimum Required)

Director Clinical Affairs Resume Examples & Samples

Responsible to develop and mentor staff; responsible for people-management activities of direct and indirect staff
Responsible for implementing and maintaining the effectiveness of the Quality System
Actively participate in the planning and supporting of clinical relationships with Key Opinion Leaders (KOLs) and speakers
Overall responsibility for managing the post-marketing Clinical Program (investigator-initiated studies, institutional retrospective analyses, publishable process-mapping studies)
This position requires between 25-40% travel
Providing a significant and positive impact to short-term, mid-range and long-term organizational goals
Creating a work environment that supports cross-functional effectiveness
Management and development of reporting staff; mentor others as appropriate
Understanding of the clinical laboratory, assay / instrument principals involving in-vitro diagnostic product design and usage; scientific, regulatory and compliance requirements of clinical research
Ability to clearly, concisely and accurately convey communications in verbal and written formats, particular scientific communications; polished presentation skills are critical
Ability to form and develop interpersonal, professional relationships; displays socially and professionally appropriate behavior
Ability to motivate and lead a diverse staff to drive the execution of critical strategies and programs across a large organization
Ability to accurately evaluate and assess complex processes; identify possible solutions and drive to resolution
Ability to lead and influence both with and without direct authority
Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical diagnostics/devices
Ability to work independently and in groups; ability to collaborate across the business, across Abbott businesses and with outside resources

Director, Clinical Data Sciences Resume Examples & Samples

Brings people, processes and technologies together to generate business value from data
Ensures that technology and processes are established globally to provide the organization with efficient systems to collect, process, summarize, and analyze clinical data across all therapeutic areas and sites. All enterprise clinical data technologies, ancillary systems and emerging technologies are within the purview of the Director
Accountable to guarantee operations meet good clinical practice through establishment of controls, measures and by development of a quality-conscious culture
Accountable for optimization and standardization of operations for a global CDS organization
Accountable for building scalable business strategy and for managing execution against available budget
Builds strong lasting relationships with Data Sciences leaders and staff, and with cross-functional leaders
Establishes an environment and substructures to foster continuous improvement
Cultivates future leaders of both Data Sciences and other functions through talent management processes
Accountable for the agile development of clinical trials databases and data capture systems, for the integrity of collected data, and for the overall continuity of clinical data processes for AbbVie clinical development

Director, Clinical Biomarkers Oncology Resume Examples & Samples

MD or PhD biology degree
Experienced scientist with 9+ years experience in the drug development process
Record of accomplishment in oncology and/or tumor-immunology disease biology
Demonstrated experience in the appropriate application various scientific technologies into translational research strategies
Ability to multitask across multiple development assets
Functional leads and team members
1602810

Director, Clinical R&d-dermatology, MD Resume Examples & Samples

Define and develop Target Product Profiles
Design and optimize clinical trial design; ensure clinical trials meet ethical and regulatory standards
Responsible for the quality, coordination, medical and scientific accuracy and timeliness of clinical study reports
Work with the Executive Director and VP in Clinical R&D, and other cross-functional team members to prepare abstracts, manuscripts and presentations for external meetings, as well as author clinical sections of regulatory documents (IB, IND sections)
Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports
Participate as clinical representative on multidisciplinary Project Teams
Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation
Maintain clinical and scientific awareness in area of expertise
Guide day to day work of Clinical Research Scientists
Manage lifecycle requirements and plans for designated indications
Understanding of Dermatology drug development process
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Experience in designing Clinical trial strategies to obtain regulatory approval
Experience in Clinical project planning
Experience working on global and complex Clinical trials
Experience working effectively in a team/matrix environment
Strong scientific/technical skills
Strong interpersonal capabilities and ability to build networks
Proficiency in anticipating and resolving problems
Excellent managerial and leadership skills
Excellent verbal communication and technical writing skills
Ability to present clearly using scientific and clinical terminology
Ability to lead cross-functional teams and a true team player
Possesses sense of urgency and can take initiative
Project management skills and focus on delivery of results
People management skills
Ability to motivate

Director, Clinical Trial Info Disclosure Resume Examples & Samples

Bachelor Degree in pharmacy, biology, chemistry, medicine, or equivalent; Master or PhD preferred
Minimum of 10‐12 years’ experience in the pharmaceutical industry with at least 4 – 6 years experience in the area of clinical trial information disclosure
Established network with other pharmaceutical companies and industry associations
Working knowledge of key global laws, regulations and guidelines relating to clinical trial data disclosure is essential
Experience of working in a global, international regulatory environment and experience in interacting with regulatory authorities
Experience working within a global team framework and a multi‐cultural environment
Excellent interpersonal skills; ability to work across functions in a multinational organization to accomplish results. Be “detailed‐oriented”; well organized and self‐motivated; high ethical behavior, excellent written and oral communication skills. Excellent influencing skills
Understanding of drug development and regulatory processes
Track record of productive interactions with FDA, EMA and/ or EU National Agencies and EMA as well as with industry associations
Ability to provide strategic and technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects
Excellent research and project management skills

Director, Clinical Quality Operations Resume Examples & Samples

Mentor Clinical Development Staff and partner in areas of GCP compliance including
Monitoring oversight
Ability to bring investigators into compliance
Drug accountability of IP on studies
Training records for training on SOPs and Study Specific areas i.e.: Protocol
TMFs for adherence to SOP and timely filing of all documents
Responsible for assuring that Clinical Development is “inspectionready” for internal and external audits
GCP expert advice/interpretation to Clinical Teams/SOP assistance
Provide SME expert GCP advice to Clinical Development based on analysis and interpretation of updates to GCP regulations to assure best clinical practices are follows
Facilitate continuous improvement processes within Clinical Operations
Assist in the development and revision of SOPs
Audits and Inspections Management
Will host regulatory inspections from agencies such as FDA or partner inspections
Lead clinical teams in the preparation, coordination and documentation of regulatory inspections of investigator sites or sponsor inspections
Direct post audit response efforts and oversight of all remediation tasks
Evaluate the potential risk of compliance deficiencies utilizing metrics and trending of audit findings
Support remediation and corrective efforts of sites, vendors, contractors and CROs
Evaluate the need for, and oversight of, audits of external investigator sites, vendors and internal processes, including documentation systems and compliance with appropriate regulations
Develop and update an Annual Quality Management Plan involving appropriate support from all Clinical Development Groups
GCP Task Force/GCP Systems Implementation and Oversight
Serve as a member of the GCP Task Force Team
Work with Clinical Development in the implementation of Systems (i.e.: LMS, E-TMF, CTMS)

Director / Senior Director, Clinical Affairs Resume Examples & Samples

Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of the project and provides clinical and therapeutic expertise, with a strong working knowledge of regulatory affairs, to the development of the project strategy and the clinical development plan (CDP)
Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc)
Develops, executes and regularly maintains the project CDP and other relevant clinical documents that are consistent with the project goals
Consults with internal/external stakeholders and internal/external key opinion leaders to validate the scientific and medical components of the CDP
Works closely with the clinical operations group, and provides strategic direction to support timely and on budget development and execution of the clinical development program
Serves as the medical or scientific representative with investigators and regulatory authorities
Interacts with the Medical Science Liaison personnel
Mentors and transfers knowledge across project teams
Participates and supports the clinical study team in site selection/evaluation including site training and to provide sufficient Medical/scientific knowledge for educating the study team and investigators and explain the scientific, epidemiologic background and justification of a study/project
Participates as lead clinical representative on cross-functional project team
Supports clinical study and operational teams
Accountable for the clinical study reports including expert reports, integrated summaries, and other regulatory documents, etc
Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. To serve as the main scientific/medical representative during these interactions, with support from other project team members as needed
Provides input for a project publication plan, liaises with commercial and work on launch activities when required
Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio
Reviews abstracts and manuscripts created by internal or external sources
Demonstrated ability to manage multiple and diverse projects concurrently
Demonstrated ability to develop relationships and generate collaborations
Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record
Solid medical/scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents
Working knowledge of statistics, data analysis and data interpretation

Associate Director, Clinical Outsourcing Resume Examples & Samples

Develop and execute annual sourcing plans for Clinical Outsourcing
Perform and lead all activities associated with the development and execution of contracts for clinical (CDRA) services to include Regulatory and Medical Affairs
Review major contracts for key areas of spend. Expert resource for planning and leading complex negotiations
Prepare study specific request for proposals (RFPs); manage and influence RFP process (vendor selection), competitive bidding negotiations, benchmarking
Lead the vendor evaluation and selection process, provide guidance to internal client on supplier selection and strategy
Work with clinical teams to ensure the scope of service in contract meet the needs of project
Lead lessons learned sessions with internal clients and external vendors
Utilize clinical budgeting, planning and forecasting tools (Clear Trial or similar)
Develop and manage vendor relationships and issue resolution of moderate to high complexity, support project team in resolution of performance issues
Lead supplier governance committees
Involved in projects or programs (complex and multiple)
Contribute to strategy and new processes
Interact with internal and external customers
Maintain current awareness of clinical outsourcing market and industry trends
Define category performance targets and leads team to achieve goals
Drive annual productivity improvements in each category of spend by developing and ensuring implementation of ideas to optimize total cost of ownership for spend categories
Measure and track internal performance within each spend category by tracking forecasted vs actual savings and budget impact for portfolio of categories
Identifying/defining sourcing best practices both within and outside of Regeneron and ensuring those best practices are adopted
Leverages strong influencing skills to define sourcing role and align project objectives and targets with stakeholders
Monitor key Suppliers performance; ensure effective Supplier Relationship Management to drive continuous improvements
Communicate team progress to Senior Director, Procurement and business unit leaders
Advanced knowledge of contract terms and conditions, C.C.C.M. Certification, desirable
Advanced knowledge of benchmarking, market analyses and financial negotiations
Knowledge of clinical development
Advanced problem solving skills in a team environment
Excellent negotiation or influencing skills
Proficient in drug development process
Competent in computer skills, oral & written communication & multi-tasking
Ability to manage personal timelines
Ability to establish and influence team timelines & expectations
Minimum 12 years Procurement experience, 7+ years in the Pharmaceutical Industry; 7+ years in outsourcing Phase I –IV clinical trial services, BA/BS degree in life sciences, business, finance or equivalent

Director Clinical Studies Diabetes MD Resume Examples & Samples

The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or
Strong Scientific and medical expertise, in particular in diabetes
Strong expertise in clinical development and methodology of clinical studies
Strong leadership
Quality focused and well organized
Strong decision maker
Ability to negotiate
Ability to develop an holistic approach as regard to study and program conduct

Director, Clinical Project Ldr Mgt for Cras Resume Examples & Samples

Direct/lead team that is conducting Phase I-IV clinical trials in a timely, ethical and scientifically responsible fashion. Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned studies. Responsible for the direct management of the OCPLs to ensure execution and compliance with the designated duties as per the NA CSU Project Management Head. Ensure that all activities under his/her direction comply with Sanofi Research & Development SOPs, NA CSU/US CSU SOPs, GCPs and country specific regulations
Responsible for evaluating and developing strategic direction of the group including strategies for flexible sourcing, process optimization, training, resource allocation and utilization and fit for purpose assessment
Responsible for driving initiatives through root cause analysis and continuous improvement to support the goal of Sponsor of choice 2020 and improve our Investigator site experience
Conducts objective setting and ensures that individuals have well-defined attainable and measurable objectives aligned with those of the Company, Project Team, CSU, and personal developmental needs and aspirations. Conducts high quality performance appraisals with ongoing performance feedback and coaching. Ensures written performance appraisals and developmental activity plans are adequate to facilitate effective individual development, talent management, succession planning and identification of training needs
Key operational interface with internal and external services to develop, implement, maintain and improve operational processes for NA CSU clinical study conduct and enrollment. Ensures communication pathway, promotes productivity and performance. Collaborates with other Director, CPL Mgt to identify best standards and efficiencies for trial conduct across the NA CSU
Interface with the other Director, CPL Mgt and CSO Project Leaders, CTOMs, CSDs, and Project Heads to understand portfolio and project needs and ensure optimal flow of information relative to study status, challenges, risks, etc
Ensures study delivery per CSU commitments. Ensures effective communication and mitigation of study risks/challenges and seeks input/assistance from relevant stakeholders when appropriate. Assists individuals in problem solving and corrective measures while encouraging resolution at lowest empowered level and escalating when appropriate
Actively participates, as applicable, in the strategic assessment and evaluation of the Study Start Up Unit through development of standards, processes and metrics. Works to further optimize, improve performance and create efficiency in delivery of study start up timelines across NA CSU programs
Manage the resource pool of CRAs (170 FTEs) expertly by developing site allocation and utilization methodology designed to efficiently allocate CRAs to sites and studies, considering geographic location, CRA expertise & experience, study needs, etc., with the goal for maximum utilization and seamless coverage of our study sites. Additionally this role will evaluate, recommend and implement a resourcing tool to be used for future
Work closely with our resource partnerships in an effort to improve the overall effectiveness and delivery of services through improving communication and supporting established partnership values
Ensure audit report findings are consolidated & communicated as lessons learned. Fosters NA CSU operational improvements as warranted
Drives change and implementation of new approaches and standards within his/her group. Ensures consistent, timely and appropriate circulation of updated information and adequate reporting of implemented actions internally and externally as required or requested. Participates in the development of local/global SOPs, policies, guidelines or related tools via participation in working groups and collaboration across CSU and CSO
Bachelor's degree in a Science/Medical or related field and 12+ years of pharmaceutical industry experience including 3+ years’ experience in the direct management of people required
5+ years of clinical trial experience/clinical trial management experience & 3 years of previous field monitoring experience required. Alternatively, demonstrated comparable or equivalent experience will be considered
Demonstrated ability to effectively lead by influence and operate as a role model of company values
Advanced knowledge of drug development, therapeutic area disease states, clinical study execution, project management, principles, FDA regulations and ICH /GCP guidelines. Respect for Quality and Compliance in all aspects of clinical trial conduct
Experience in identification, development, design and implementation of operational procedures, budgeting and resource management
Strong leadership, mentorship, organizational and time management skills required
Excellent analytical, interpersonal and communication skills (verbal and written) essential
Ability to provide internal/external operational expertise for a given therapeutic area
Demonstrated supervisory and managerial skills, including ability to influence and motivate people
Demonstrated ability to give developmental feedback on performance assessments
Solutions oriented business acumen important, along with critical decision making and self-motivation qualities
Cross functional operations understanding is essential
Advanced degree in a Science/Medical or related field
ACRP/SOCRA certification

Director, Clinical Consulting Resume Examples & Samples

The primary role of this job is client-facing delivery of clinical advisory services
Performing onsite capability and gap assessments, for provider organizations, health plans and VBC networks (ACO, CIN, etc)
Facilitating and leading client workgroups and committees
Producing deliverables in collaboration with project team
Developing, communicating and presenting client-facing consulting reports and presentations
Serving as interim staff for clients in transition to Value Based Care
Creating original content and refining existing content to augment Care Model and related offerings and other new consulting offerings
Updating and refining related deliverables
Developing collateral materials to support sales; including domain expertise for presentations and proposal development
Supporting optimization of Valence Health technology through pre-, concurrent, and post-implementation advisory services
Developing delivering educational sessions for internal and external audiences
2-4 years of healthcare consulting experience
Care Management/Population Health experience, preferably in either a practice or facility program
Collaboration and teamwork oriented
Strong positive problem solving approach to complex issues, with a wide degree of creativity
Able to think strategically and also focus on important project details
Process improvement oriented, generates new ideas that can positively impact firm’s success

Director, Clinical Affairs Infectious Disease Resume Examples & Samples

Collaborate with GBU leaders and cross-functional stakeholders from R&D, regulatory affairs, biostatistics, and marketing, and with external investigators to develop clinical strategies, objectives and study designs for validation of new ID products in support of regulatory submissions globally
Direct and manage a clinical team to execute study designs that deliver definitive results on time, on budget and in full compliance with all applicable quality and regulatory requirements
Communicate status, timeline, budget and issues for all studies conducted by the department to relevant GBU leaders and department stakeholders; prepare status dashboards as needed
Prepare department budgets, manage expenses and revise budget forecasts on regular basis in conjunction with finance partners
Work with clinical study managers to negotiate study budgets with investigational sites that are fair to all parties and ensure study objectives will be met
Collaborate with the legal department to develop clinical study agreements with investigational sites that are compliant and protect the interests of the business
Work effectively in a culture that emphasizes quality first, a culture that is fast-paced and dynamic, and a culture in which cost containment, management of expenses and operational efficiencies are a strategic imperative
Provide leadership and direction to the clinical team and effectively delegate appropriate tasks, assignments, and responsibilities
Provide appropriate training for team members to ensure consistent execution of all study related activities and opportunities for professional growth
Have good knowledge of and experience with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices (GCPs)
Ensure clinical standard operating procedures (SOPs) are in full compliance with GCPs and all related quality and regulatory requirements
Ensure all studies are conducted in full compliance with GCPs and company SOPs
Work with clinical data management group to ensure CRF design, CRF completion, resolution of queries, and database lock activities are completed in accordance with all applicable quality standards and timelines
Travel is expected to be 10-20%. Travel to sites for study initiation, training and assessment of research study team activities may be necessary at times. Travel to Alere San Diego or other Alere companies will be necessary at times
Knowledge and experience working with assays and platforms designed for detection of infectious disease agents in various samples types
Knowledge and experience with assays and platforms that detect antigens (viral and bacterial) and antibodies using immunoassay and molecular diagnostic technologies
Knowledge and experience with FDA requirements for clinical validation of infectious disease assays using point-of-care systems for 510k clearance and CLIA waiver
Experience with and in-depth knowledge of FDA, ICH and GCP requirements for conducting clinical studies
Knowledge and experience in developing and maintaining department SOPs
Strong management skills with proven leadership and team building skills
Good working knowledge of clinical data management and statistics, and strong computer skills using Microsoft Excel, Word, and Outlook
Ability to work within established timelines, in a fast paced environment
Excellent organizational and priority management skills
Good interpersonal skills and ability to interact with people at all levels and within all departments of the company

Director Clinical Systems Engineering Resume Examples & Samples

Develops and leads the annual Clinical Technology Plan (CTP) for NCAL Region. Responsible for all technologies and sub-committees (19) to deliver their annual executive scoping presentation. Leads the process to get approval of CTP by December each year. Leads and recommends strategies and technology acquisitions to Regional Leadership and drives data driven, evidence-based approaches. Brings new innovative ideas and approaches to improve processes
Oversees and directs the implementation of the annual CTP ($100M). Forecasts the spend plan by technology and month to meet business goals. Responsible for leading team to coordinate with planning, design, KPIT, Capital Projects, and Service Area stakeholders to meet delivery schedules, timelines, and budgets
Leads and manages the team of Clinical System Engineers. Develops a high performance culture through coaching and developing team. Responsible for developing team's ability to think critically, develop strategies and improve communication skills
Leads and develops technology integration strategies with KPIT (Kaiser Permanente Information Technology), BDIC, (Biomed Device Integration Council) and MDIP (Medical Device Integration Program). Responsible for ensuring clinical data is supported, protected, and is integrated into Kaiser EMR system. Drives alignment with regional TRB and TCG to ensure initiatives are balanced and funded appropriately
Continuously monitors and analyzes technology trends and markets to develop innovative planning and consulting strategies. Oversee teams coordinating Regional technology pilots to evaluate clinical and operational benefits of technology
Minimum five (5) years of experience in management in healthcare
Minimum five (5) years of experience in engineering
Significant management experiences (10 years) in clinical systems engineering in a mult-hospital environment to include, analyzing healthcare technology markets, planning implementing and disposing of medical technologies
MBA preferred

Regional Director, Clinical Transformation Resume Examples & Samples

Support the goals of the National Director
Develop and implement initiatives to achieve clinical and financial operations program goals
Identify and implement program development opportunities to support affordability and growth targets
Train on and support the use of technology and software applications utilized in the support of the Accountable Care Communities program
Measure and communicate performance metrics and expectations at the employee, practice, market and region level
Identify causes of performance deficiencies and determine appropriate process improvement actions
Drive identification, implementation and syndication of best practices and standards
Assist in the hiring, onboarding, training and personal/professional growth of all staff within assigned geography
Prepare, read and disseminate Accountable Care Community key performance reports, identify reasons for performance gaps, and identify opportunities for improved performance
Support efforts of National Program, National Director, state Plan and other constituents as assigned
1 years of experience as a Transformation Consultant within the Accountable Care Communities and / or Health Homes program
Practice management / operations experience
Strong clinical data analytic skills measuring process and outcomes in healthcare
Experience managing change initiatives for health care teams
Strong skills presenting complex data and outcomes to executive teams
Medicaid managed care experience
Excellent planning and strong problem solving skills that enable quick identification and efficient issue resolution
Ability to organize and thrive in a fast-paced environment
Access database technical skills
Ability to build the right team, focus people and model / demand integrity
CPHQ certification
Six Sigma / Lean certification
Master’s Degree in Health Informatics, Business and / or Public Health

Associate Director, Clinical Ops Resume Examples & Samples

Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, compliance, and development of contingency plans, among others. Access and analyze performance and quality metrics to address improvement initiatives
Manage the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions. Actively participates in the selection and hiring process
Ensures quality and adherence to SOP/WI. Ensures all staff follows required training and completes the required documentation. Provides regular updates to management accordingly
Ensures individual and work group/team tasks are completed according to country/region specific and government regulations
Conducts or coordinates various types of assessment visits to ensure Clinical Operations on-site performance. May develop and oversee training plans for individuals or groups to address performance deficiencies. Ensures staff adheres to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed
Identify needs and may make recommendations for process improvement and efficiencies
May provide support to Business Development to facilitate the winning of new projects during the Bid Defense process, providing expert guidance where required. May participate in marketing activities, client presentations and proposal development

Director, Clinical Biospecimen Management Resume Examples & Samples

Responsible for oversight of all biospecimen related activities relating to all active and closed studies, including oversight and management of all biospecimen requests, consent and logistics
Oversee the resolution of all escalated issues and queries related to biospecimen retrieval for active and closed studies
Ensure effective oversight, training, and guidance is provided to Biospecimen planners involved in assigned portfolio of programs
Provide strategic guidance for Biospecimen Management Plans developed for active studies
Business Process owner for all CBM processes employed to manage the CBM process. Ultimate accountability for ensuring that all SOPs, processes, standards, templates, and policies related to clinical biospecimen management are developed, maintained, and adhered to within the department
Serve as Chair of the BioMarin Biospecimen Authorization Committee (BAC), providing guidance on the use of biospecimens other than for the primary purpose of collection (including study specific exploratory use and other future exploratory use)
Responsible for ensuring that the BAC is effective and achieves internal and external goals
Adjudicate escalated issues with, and exceptions to, the biospecimen authorization process for the use of BioMarin biospecimens
Provide overall BioMarin guidance on the biospecimen management lifecycle and authorization process
Establish and approve key policies and procedures for the management and approval of Clinical biospecimen use at BioMarin
Continuous improvement associated with both the process and the effective re-use of biospecimens
Lead and collaborate with the BAC in establishing guidelines for the following
Study / registry trigger points for biospecimen availability for use
Biospecimen stability and retention criteria
Biospecimen destruction criteria
Blinding / unblinding practices
De-identification practices
Standard consent language and interpretation
Definition of study specific vs. other exploratory use
Quantity of biospecimen required to be retained
Scientific prioritization of biospecimen use
Facilitate timely and effective communications of BAC decisions and progress to all key internal stakeholders, in addition to communicating significant decisions and issues (including those of any functional area sub-teams) back to the BAC
Ensure development and review of biospecimen request metrics and dashboards
Ensure that the design, implementation, and support of CBM systems is in line with broader BioMarin strategy and stated goals
Ensure a high standard is held in the design, implementation, and support of CBM systems
Oversee and approve IT investment roadmaps
Oversee the development of CBM business requirements for system design
Oversee the planning and implementation of CBM system enhancements and upgrades, ensuring a high standard of excellence
Oversee service provider relationships for all outsourced activities for CBM
Ensure appropriate CBM service provider management activities are occurring across all programs
Escalation point for any service provider issues that may impact study or program deliverables in collaboration with COA
Oversee CBM involvement in vendor Quarterly Business Review meetings
Ensure appropriate functional or cross-functional governance is in place for any service providers that support CBM
Contribute to service provider selection decisions as appropriate
Ensure overall compliance with GCP guidelines (including BioMarin SOPs, ICH, FDA, and other HAs) for all CBM activities related to clinical biospecimen management. Oversee the development and revision of CBM standards and the implementation of action plans based on shifting regulations
Communicate risks and mitigation strategies relating to scope, timelines, resources and quality to Development Sciences Sr. Leadership in a timely manner
Develop positive and strong working relationships with all key internal and external stakeholders involved in clinical biospecimen management; model effective collaboration
Lead the establishment and execution of operational improvement and departmental change initiatives as needed to achieve strategic goals
Responsible for the development of department strategy, goals, vision, core competencies, resourcing, staff management, budget, etc
In collaboration with CBM leadership team, facilitate department interactions, activities, and operations (e.g., adequate staffing, training, department level initiatives, etc.)
Be an advocate for the department within BioMarin
12 years of pharmaceutical industry or related industry experience
6 years of experience in clinical research, laboratory management, clinical biospecimen management, or a related discipline. Biobanking and/or specimen acquisition experience highly desired
5 or more years of line management experience
Gain support for ideas across all levels and branches of the organization
Demonstrate leadership as a sought-after master of decision-making and issue resolution
Motivate teams and direct reports to prioritize and focus on career development, clearly communicate sensitive and difficult information using the appropriate communication style, and create and articulate a vision for organizational change
Senior Manager, CBM Operations
Senior Manager, CBM Compliance & Standards
Manager, CBM Systems

Director, Clinical Solutions Resume Examples & Samples

Act as the clinical Subject Matter Expert to assist in product development enhancements, updates or improvements
Fluently understands the components of a clinical study, the relationships between those activities and be able to interpret and communicate such information to internal product development and the broader ClearTrial customer community
Clinical expert across major clinical functional and/or therapeutic area indications for industry best practices and new product requirements
8+ years experience in clinical outsourcing and clinical project management, with strong experience in the following areas
Experience with clinical trial systems (CTMS, EDC, IVR, etc.) and clinical trial processes
PMP certification

Senior Director, Clinical Excellence Resume Examples & Samples

Works closely with Performance Improvement Division Vice President, Division and Facility leadership to identify and determine facility clinical variance opportunities and targets based on peer group analysis
Works directly with physicians, executive leaders, directors and staff to implement and maintain clinical performance improvement
Strategically plans and implements clinical performance improvement projects with hospital executives and division leadership
Drives improved clinical outcomes through the development and deployment of standard toolkits, processes and clinical assessments
Adheres to a proven Performance Improvement methodology for Clinical Excellence
Provides best practices and clinical evidence to physicians and multi-disciplinary teams to assist in clinical performance improvement
Facilitates Rapid Design Sessions to identify clinical performance opportunities and clinical process improvements, including identification of best demonstrated practices
Works with PI Division VP to adjust PI CE strategies to respond to changing business needs
Communicates timely and effectively in a matrix environment
Drives business decisions through the development and use of analytics

Senior Director Clinical Excellence Resume Examples & Samples

Directs multi-disciplinary team in identifying and implementing sustainable changes that result in a reduction in avoidable clinical variation at assigned facilities
Analyzes clinical performance data to identify clinical variation opportunities and makes recommendations to facility and division leadership in alignment with the facility's strategic plan
Executes on established performance improvement agenda in surgical operations, emergency room operations and clinical excellence
Recommends changes or improvements based on research and evidence to implement clinical best practices
Collaborates with Division Chief Medical Officer, VP of Quality and corporate groups to implement clinical performance improvement strategies
Collaborates with facility, division and corporate leaders to develop and/or identify best demonstrated practices to improve clinical and operational performance
Coordinates division and corporate resources to ensure successful execution of established clinical performance agenda
Prioritizes PI CE work based upon the needs of the business and in accordance and alignment with company strategy
Ensures standardization and consistency across engagements; Communicates routinely with Performance Improvement Division Vice President to ensure alignment across Clinical Excellence program
Serves as the Performance Improvement primary consultant in clinical performance improvement and implementation teams
Develops presentations to present to a wide audience at the hospital and division levels
Actively participates in projects and conversations with Performance Improvement-focused peers in other divisions via corporate support structure and contributes to enterprise best practice library
Works in a remote and in a matrix environment
10 years professional work experience required
5 – 7 relevant work experience required
Experience in working with physicians and/or other clinicians in driving efficiency and value required
HCA clinical and financial systems experience preferred
Executive level interpersonal skills and the ability to work within a matrix environment is a must
Excellent Power Point, Excel, Outlook and Work experience required
Division based, travel required, % based on division geographic locations

Associate Director, Clinical Domain Expert Resume Examples & Samples

A minimum of a Bachelor’s Degree (or equivalent degree) is required. An advanced degree (MS, PhD, PharmD, etc) is preferred
A minimum of 10 years in and R&D, and/or quality and compliance area is required
Expertise in one or more specific compliance disciplines (non-regulated, GLP, GCP, PV, Non Regulated or computerized systems) is required
Knowledge of auditing techniques is preferred
Experience of coaching and mentoring others is preferred
Fluent written and spoken English is required
Excellent presentation, negotiation and influencing skills are required
Strategic thinking and quality mindset is required
This position’s preferred locations include Spring House, PA; Titusville, NJ; Raritan, NJ; Malvern, PA; Beerse, Belgium; High Wycombe, UK; Leiden, Netherlands; or Tilburg, Netherlands, (Other locations may be considered), and may require up to 20% domestic and international travel

Assistant Director, Clinical Services Resume Examples & Samples

Ph.D. or Psy.D. in Counseling or Clinical Psychology from an APA-approved program
Successful completion of a one-year pre-doctoral internship required, preferably from an APA-approved internship program
Four years of experience as a generalist therapist required. Pre-doctoral psychology internship may be considered in lieu of one year of experience
Must be currently certified or licensed, or immediately license eligible in the State of Indiana (if current psychologist license is in another state)
Strong general therapy skills with clear interest and experience in the college population, as well as in issues of diversity, social justice and advocacy
Knowledge of, and adherence to, ethical, legal and professional standards of practice
Independent judgment and discretion are essential in all aspects of this job
Ability to function well as part of a collaborative team
Strong organizational, planning, and problem-solving skills
Ability to provide positive leadership
Ability to relate well to students, medical and professional personnel, faculty, and other members of the University community

Associate Director, Clinical Trials Resume Examples & Samples

Manages day-to-day operations of the clinical staff including recruitment of staff, evaluates and communicates employee performance on an on-going basis, participates in compensation process, directs and prioritizes staff workloads
Manage the conduct and execution of clinical trials complex in scope and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements
Ensures clinical study timelines are achieved; oversight of study budgets
Interprets and applies relevant general and therapeutic are specific ICH, CPMCP and FDA guidance
Directs all aspects of clinical trial implementation from vendor selection, study initiation and conduct, final reporting
Oversees clinical study reports to ensure data is correctly presented and content is consistent to the overall clinical development goals
Oversees the vendor selection process including budget and contract negotiations and site evaluations
Assures team members are adhering to SOPs and study guidelines
Participates in development and delivery of product development training
Works on special projects as needed
Provides appropriate guidance and ensures the growth of all direct reports
Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and provides feedback to direct reports and colleagues
Bachelor's degree with eight to ten years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience
Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists. Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English
Must have experience interfacing and managing multiple vendors and contracts
Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule

Director, Clinical Trial Data Sharing Resume Examples & Samples

Demonstrated leadership in a related role
Experience with development of highly-visible, corporate, cross-functional initiatives
R&D/regulatory experience
Understanding of US and EU Clinical Trial Data Sharing requirements and commitments
Experience in process management/project management
Experience with external initiatives (e.g., advocating for change at Health Authority, trade assoc consortia)
History of leading high-performing team(s) cross-functionally, and of managing external vendors and consultants
Demonstrated ability to collaborate cross-functionally
Excellent communication skills; both written & verbal
Results oriented, problem solver
Strong organizational and project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
Strong interpersonal skills and the ability to effectively influence colleagues at all levels of the company including but not limited to research, development, commercial, IT etc
Bachelor of Science in related science field
10+ years industry experience in pharmaceutical or biotech company, and
5+ years experience working in R&D
1-3 years in a management role
Experience with clinical trial data sharing
Experience interacting with external stakeholders
Ability to work independently with minimal direction on multiple complex projects
Strong knowledge of pharmaceutical development process
Computer literacy (Microsoft Office)

Director, Clinical Systems Management Resume Examples & Samples

Platform Management
Oversee development/primary owner of processes and system documentation and ensure key stakeholders are involved in the review, implementation and management of processes and documents. This includes, but is not limited to, SOPs, WPs, Forms, Tools/User Guides, Training Materials and Validation documents
Oversee/assess impact of proposed integrations or other types of changes Identify, facilitate and help drive decision making for system upgrades. Assess business impact (with functional representatives) and drive implementation
Ensure coordinated tracking of enhancements and defects
Align with vendor on new releases
Prioritize and drive capability requirements
Partner with vendors and internal IT for Roadmap management
Identify needs and resources for significant upgrades
Monitor all processes to ensure being followed
Stakeholder Management
Lead development of business case(s) for new capabilities/modules working with internal and external stakeholders and functional business leads/SMEs
Drive training and communications across internal and external stakeholders
Actively engage with clinical systems governance committee and lead/facilitate cross-functional platform discussions
Coordinate with functional leads to manage external stakeholder (e.g. CRO) impact through development and implementation of a communication and change management plan
Contract and Financial Management
Manage and oversee vendor contracts in collaboration with IT and Procurement
Manage relationship with system vendor
Review and approve vendor invoices
Performance/Use Management
Track Platform usage
Oversee, manage and report process and value realization metrics
Analyze trends
Audit and Compliance Management
Manage audit / inspection touch points
Ensure compliance / usage of operational terms and definitions, business rules as defined by associated governance bodies
Excellent people interaction skills, adaptability, strong professional diplomacy and positive business approach
Excellent problem solving ability and analytical approach, with a focus on strategy development and execution, with strong ability to manage and re-prioritize competing responsibilities independently
Demonstrated ability to drive execution and innovation in a dynamic environment
Self-motivated with exceptional follow-through
Experience in successfully implementing new business capabilities and technology solutions
Proficient with risk and issue management and resolution; fosters calculated risk taking
Proficient with business process, operations and metric definition best practices
Familiarity with clinical system regulations/requirements

Associate Director Clinical Performance Management Resume Examples & Samples

On a client by client basis evaluate trends and performance against book of business targets for key indicators and developing corrective action plans when required
Collaborate with account management, site operations leadership and program partners to execute action plans and monitor programs
Provide account management assistance with client presentations, interpretation of data, etc. around escalated member issues
Perform annual clinical analytical review on top accounts and others as requested and 1) Communicate variances to, or achievement of, committed metrics consistent with OptumHealth product definitions and / or performance guarantees and 2) Identify clinical product opportunities and make recommendations with defined value to support client population needs
Develop solutions based on client’s business requirements and/or internal operational process gaps; there is responsibility for working independently on complex clients, including those that require sophisticated integrations or new processes
Provide program and operational design oversight of customer implementations
Act as a clinical resource and subject matter expert (SME) to operational staff for innovative customer program design and development
Provide oversight of customer implementations, working independently on those that involve multifaceted clinical products and deliverables
Communicate client specific factors that may affect performance to account management, site operations and program partners including but not limited to: Client value drivers, Vendor issues, Network / clinical gaps, etc
Review processes to identify barriers which may contribute to underperformance specified accounts
Propose alternatives in collaboration with site operations and program partners that are cost / benefit neutral
Act as a liaison / informational resource for external program vendors, internal partners, and peers. Also, as needed serve in a client facing role to represent OptumHealth products and services
Provide assistance to the operational site in preparing for all client and external audits and represent operations during the audits for clinical program changes and the advancement of solutions to currently identified gaps
Proactively identify best practices across sites and assist operational teams in implementing those same best practices in other sites when appropriate
RN License
4 year Bachelors level education
5 + years in a managed care environment
5 + years of experience in operations inclusive of problem solving, process development and consensus building, preferably with multiple functions / departments
3+ years of proven analytics experience (gathering / analyzing data, developing reports, identifying appropriate changes/improvements, creating action steps based upon findings)
Up to 25% travel
Proficient in Word, Excel, Access, PowerPoint
Strong working knowledge of clinical / healthcare operations
Experience in utilization management, case management, disease management or discharge planning

Senior Director, Clinical Biomarker Lead Resume Examples & Samples

During research phase, provides inputs as translational biomarker plans are developed by the Translational Biomarker Lead
Takes on responsibility for biomarker plans as projects near the clinic.Implementation of Clinical Biomarker plans
Works with Clinical Study Teams and clinical colleagues to ensure appropriate inclusion of Clinical Biomarkers in clinical studies, including study design
Works with Research to ensure appropriate interpretation of biomarker readouts
Works with Clinical Pharmacology and M&S to support utilization of quantitative pharmacological approaches during development
Serves as a key member of project teams, providing expert input to teams and guiding clinical development of biomarkers through the Development phases
Collaborates with colleagues from Research to ensure assay validation of clinical biomarker assays complete prior to implementation
Works with colleagues across the clinical and research organizations to foster an end-to-end view of drug development, always focusing on improving patient care
In collaboration with Translational Biomarker Lead, identify opportunities for biomarker-focused external collaboration and lead collaborations
Maintains close contact with the program leadership to communicate biomarker activities
Acts as conduit of communication between clinical teams and Clinical Biomarkers personnel
Maintains an understanding of the lead compound/ VX properties
Collaborates with biostatistician to ensure analysis of biomarker results in the Statistical Analysis Plan
Contributes to Biomarker Study Plans, Analysis Plans, Study Reports, and relevant sections of regulatory and clinical documents, i.e. INDs, NDAs, IBs, CSRs
Management responsibility for Associate Biomarker Leads
MS with >10 years or PhD with >5 years of relevant work experience in biomarker discovery, evaluation and implementation of drug development
Excellent written and oral communication to diverse audiences
Knowledge and understanding of general scientific principles as applied to biomarker research, development and implementation
Ability to utilize a diverse set of technological approaches to address biomarker research/development
Knowledge of Good Clinical Practices, clinical study design and implementation

Director, Clinical Quality Informatics Resume Examples & Samples

Five years of practical experience in managing clinical data preparation in a health care environment; data abstraction, validation and display
Effective verbal and written communication and presentation skills; proficiency in translating complex concepts
Demonstrated ability to manage multiple complex projects simultaneously and maintain flexibility to adapt to a changing environment
Demonstrated planning and organizational skills; good problem-solving and development of creative solutions; ability to manage time efficiently and meet deadlines
Experience working in a team-oriented, collaborative environment; ability to establish effective interpersonal relationships
Proficient PC skills. Working knowledge of databases, spreadsheets, word processing and statistical software programs. Knowledge of business (operational, clinical and financial) statistics and data analyses techniques. Ability to manage and analyze data. Strong analytical thinking and problem solving skills
CPHQ preferred. Six sigma/LEAN or informatics or will obtain within 1 year of hire

Director, Clinical Market Engagement Resume Examples & Samples

Setting marketing strategy aligned with Clinical Division business objectives that connect to the broader enterprise value proposition.Designing and managing annual Business Line and Division plans and budgets
Servicing the fundamental marketing needs of the Clinical Business Lines and other Clinical Functions in creating, producing and maintaining marketing tactics essential to drive topline growth including website, press releases, positioning materials, capabilities decks, etc
Partnering with Business Line and Functional leaders by setting a strategy and framework for product launch platforms that clearly articulate the value proposition and are aligned and measurable to business goals - ensuring those plans are executed on strategy, on time and on budget
Acting as a steward of Clinical Division market presence and overall reputation through the careful maintenance and oversight of all external messaging (website content, thought leadership integrity, positioning continuity, social media presence, etc.) while ensuring integration with the enterprise
Overseeing production of multimedia content pieces such as podcasts, videos, webinars and other digital content, and collaborating with Commercial subject matter experts where appropriate
Supporting the execution of Clinical Executive Visibility activities, awards, etc
Researching and understanding competitor landscape to identify opportunities to differentiate inVentiv Health thought leadership and drive market share of voice that supports prioritized Business Line objectives
Establishing and maintaining metrics to measure KPIs and ROI and evaluate performance with respect to strategic objectives from conferences, marketing pieces, and other initiatives establishing cadence of report-back to the organization
Must have a minimum of 10-13 successful years of experience in public relations or marketing in healthcare, with 2-3 recent years' experience with a CRO
Collaborates effectively with communications and marketing professionals across the business units to apply best practices to all communications
Proven track record in managing and measuring work and communication effectiveness
Open-minded, flexible and adaptable to change
Budgeting management experience
Must be an independent and critical thinker who is a strong team player with the ability to clearly express ideas and the confidence to work with senior leaders
Proven writing capabilities in a variety of formats including C-suite communications, persuasive writing, speeches, memos and plans, related FAQs and other collateral materials, and presentations
Open communicator eager to collaborate on ideas, creative and solutions-oriented, and a natural connector of resources and best practices across the enterprise
Demonstrated ability to work under pressure, to meet tight deadlines and to manage multiple projects simultaneously and autonomously
Advanced editing and proofreading skills, along with extraordinary attention to detail while delivering against deadlines; mastery of Powerpoint and Excel
Proven manager with a client-service approach to ensure high standards and quality in all marketing and communications materials
Works well in matrix environment

Director Clinical Biomarkers Resume Examples & Samples

Collaborate with functional groups in Japan to develop and implement clinical biomarker strategies supporting all therapeutic areas and stages of drug development
Evaluate, interpret and present complex scientific data
Identify appropriate vendors and participate in vendor evaluation/selection for biomarker assay development, validation and sample analysis across diverse technology platforms
Serve as representative on drug development teams
PhD in biological sciences or related field with 8 or more years of related experience post degree. For individuals with a MS/BS 10+ years experience post degree
Must have at least 5 years industry experience in fit-for-purpose clinical assay development, validation and implementation in support of multisite clinical trials
Must have experience overseeing the establishment of biomarker assays at CROs
A strong preference for a candidate with broad technical experience (e.g. Immunochemistry, flow cytometry, genomics and molecular pathology). Candidates with genomics and/or flow cytometry a plus
Ability to work independently as well as collaboratively in a matrixed team environment
Ability to adjust priorities in a fast paced environment

Director, Clinical Outsourcing Resume Examples & Samples

Act as the single point-of-contact for assigned internal function and represent Product Development within Contracts and Outsourcing Team
Lead and manage a group of senior level Portfolio Execution Managers (PEMs) that oversee the Product Development Portfolio and Functional initiatives
Attends internal meetings with functional groups to learn of/understand functional strategies, objectives and goals. Evaluates and understands portfolio and Book Of Business for Product Development
Develops strong working relationships with all internal and external stakeholders. Strives to proactively anticipate and address business-related needs of the function to develop fit for purpose business solutions. Is accountable for delivery against commitments
Stays abreast of internal and external developments, trends and dynamics. Uses to continually evaluate current and future sourcing opportunities within assigned function. Recommends new, enhanced or revised opportunities as appropriate
Contributes to the set-up of the governance structure and represents Scientific Services as a core team member on functional leadership/management teams
Contributes to the development of joint goals, delivery expectations and accountabilities between Product Development and Scientific Services
Leads escalation and resolution of issues that could impact key deliverables to the appropriate level and implementation of any corrective actions. Work closely with Scientific Services External Alliance Leaders and Global Category Managers as appropriate
Works closely with the head of C&O to ensure that sufficient internal resources are allocated to support the functional needs
Leads and Supports Talent Development and Acquisition across C&O Product Development Team
Acts as SPOC with Scientific Sourcing PD Internal Business Partner to align on PD portfolio goals and initiatives

Director, Clinical Field Operations Resume Examples & Samples

Identifies training needs and implements appropriate training for field operations staff
Analyzes staffing needs working with Field Managers to gather necessary data to support coverage of current and upcoming studies
Identifies process improvements and works cross-functionally to develop efficiencies
Creates templates in alignment with corporate SOPs
Ensures field staff follow all elements of ICH/GCP
Provides metrics to upper management to support field operations
Works with vendors to support field operations
Bachelor’s degree or equivalent is required (preferably in a scientific discipline); a Master’s degree or PhD is preferred
Requires a minimum of 10 years of clinical research experience. Experience in related field or technology, with a minimum of seven years managerial level experience, a track record of personal career development, and clinical trial management experience is required, preferably in medical devices. Experience in critical care, cardiovascular surgery and/or interventional cardiology a plus
Documented current continuing education in clinical research monitoring or experience in Clinical Research Project management experience is a must
Working knowledge of pharmaceutical or medical device development and product life-cycle management
Strong knowledge of GCP/ICH E6 and federal regulations
Ability to understand and interpret medical/scientific data
Experience and knowledge of clinical trial reports, data presentation, and interpretation
Experience in Clinical Affairs/Medical Affairs/R&D functions
Strong interpersonal skills are required. Must have demonstrated skills in the following areas: leadership, coaching and counseling, and strategic clinical trial planning
Effectively work with and lead cross-functional teams
Experience with resourcing and financial
Experience with managing budgets

Associate Director, Clinical Programming Resume Examples & Samples

Serve as the Lead Programmer and Associate Director of the Clinical programming efforts. This may include additional responsibilities including, but not limited to
7+ years clinical programming experience in the CRO or Pharmaceutical Industry
2-5 years people/project management experience in the CRO or Pharmaceutical Industry
Knowledge of CDASH and SDTM models and transforming raw data into those standards
Strong people management skills and supervisory skills gained from direct line management and management of vendors. Proven abilities to lead and manage cross-functional projects, vendors, and people, from concept to completion
Strong verbal and written communication skills - ability to clearly and effectively present information
An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance
Advanced knowledge of SAS/Base, SAS/Macro, and SAS/SQL in a windows environment
Extensive experience and proven skills in the use of SAS within a Clinical Data Programming environment to develop and validate CRF datasets, edit checks, tables, and listings
Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle
Case report form design, data cleaning, laboratory standardizations, relational databases, and EDC Systems
Proven ability to develop and validate safety analyses
Advanced experience with

Director Clinical Ops-ccm, Eastern Region Resume Examples & Samples

Provide direction as SME related processes and procedures
Drives and supports operational effectiveness and efficiency
Contribute as requested to development of model of care
Help develop and manage customer relationships as needed
Support markets including staff, market growth and clinical needs
Oversight of utilization and metrics across the markets
Work with market clinical leadership on oversight medical cost management
Support implementations at local market level as needed
Lead new initiatives as assigned
Work with new implementations, new business for existing markets
Provide input to contracting process
May lead implementation for team on new projects at onset
Partner on interviewing clinical leadership and staff
Insures new clinical staff on-boarding is achieved
Act as mentor/support/consultant to market clinical leaders
Feedback to Market VP, Regional Presidents on clinical market function
Monitors clinical outcomes and financial metrics of markets
Follow up on best practice and on gaps
Work with market clinical leads to insure work plans in place for gaps to metrics
RN required, NP preferred
8+ years hands-on clinical / healthcare experience
2+ years clinical management experience
Experience in oversight providing guidance on tactical execution driving toward optimal clinical results
Ability to travel an average of 75%
2+ years demonstrated presentation skills, strong communication skills
1+ years experience analyzing data and setting goals driving for data driven results
Experience developing markets and / or clinical staff
Experience evaluating/assessing and develop market clinical action plans including metrics and staff oversight

Managing Director, Clinical Platforms Resume Examples & Samples

Manages technology platform development budget, business plan, business planning activities to ensure coordination of activities within OCA and across BCBSA and BCBS Plans. Builds a culture to support and deliver operational excellence and efficiency and fully integrate leading technology into OCA processes and thereafter accountable for the ongoing integration of goals and objectives of the many OCA programs and priorities
Serves as a first level management resource in addressing issues and solving problems involving strategic program management before they require Vice President, OCA attention/involvement
Develops consultative relationships with OCA and BCBSA management to improve the delivery of services and the identification of new resources and capabilities to meet customer business needs. Partners with appropriate management teams to ensure priority project goals and business objectives are met. Assists in the shaping of overall strategic direction, planning and budget process, and staffing decisions
Ensures that major platform -based initiatives and projects are achieved. Develops and leads cross-functional teams in the achievement of strategic priorities. Evaluates technology platforms in collaboration with OCA senior leadership, and refines operations/processes to improve effectiveness and efficiency as necessary
Responsible for identifying, promoting and leading development of platform projects and program operations to position OCA as a critical strategic business partner to Plans, and others. Ensures that products are competitive in external market
Responsible to lead and track strategic initiatives developed or identified by OCA and BCBSA senior leadership. Ensures that identified priorities are executed to meet business/customer objectives. Serves as a key information resource to the Chief Medical Officer and SVP
Gathers information, knowledge and insights to ensure CMO and SVP, OCA, and VP, OCA, are appropriately prepared and briefed on issues and events. Coordinates the development of briefing materials from appropriate staff for their use. Prepares background briefing and follow-up materials as needed
Leads and directs OCA key technology-based strategic initiatives. This covers a range of responsibilities including working with Plans and other industry stakeholders to support local Plan efforts to align digital health and benefit resources to improve value
Represents OCA on internal and external groups providing strategic representation on key OCA technology platforms. Interfaces with Plans and national organizations; steers and presents key strategic direction for initiative
Collaborates with CMO and SVP, OCA, and VP, OCA in developing plans and objectives for the division and ensuring coordination of activities with Plans and external stakeholders to ensure achievement of BCBSA’s objectives
Assists in the development of strategic positioning and operations integrations of BCBS Plans and internal business partners (e.g. Strategic Services, IPP, OPR) with external stakeholders (e.g. NEHI, commercial accounts, government accounts, state and city department of health, and DHHS) This covers a span of duties which include: Engage and collaborate with key internal BCBS and Blue Plan staff as well as public and private stakeholder groups to maintain unanimity of purpose and to create a unified identity for OCA resulting in greater value, program simplicity, efficiency or cost effectiveness
Oversee efforts for the integration of OCA with other evidence and government business initiatives within BCBS Plans, and their commercial and government accounts. Accountable for seeing that programs are compatible with BCBS Plan capabilities and for CHM adoption of such programs. Participates in the development OCA technology for program implementation
Responsible for (1) Ensuring the proper internal controls and collaboration exists to avoid conflict or redundancy and achieve operational feasibility for OCA and its stakeholders and (2) Ensuring internal business partners have a clear vision of business scope and purpose to provide a unified approach which aligns with BCBSA policies and procedures. Responsible for providing structure, program integration leadership and strategic direction to cross-divisional BCBSA initiatives to maximize potential for measurable improvements in healthcare safety, quality and/or outcomes for covered members
Responsible for identifying and leading development of critical operational infrastructures to support the OCA technology platforms such as technology solutions, project management systems, administrative manuals including policies and procedures
Oversees the execution of participation contracting process for OCA users including BCBSA-Plan global contracts as well as various program efforts to evolve and explore alternate contracting models as appropriate. Manages customer support and network optimization tracking and reporting
Ensures successful operation of the department by selecting, supervising, developing and evaluating the activities of subordinate staff and measure the effectiveness of their efforts in meeting departmental objectives. Conducts required/effective management responsibilities including taking corrective action when necessary and ensure that all activities are performed in compliance with budget, procurement, and other established BCBSA policies, standards, and procedures, as well as government contracting requirements. Stays current with applicable regulatory requirements
Master’s degree business related aspect
A minimum of 10 years’ work experience in a healthcare and/or business environment, or educational equivalent required, with 8 years’ experience in health care industry and demonstrated progressive responsibility and accountability including exposure to legislative, regulatory and accrediting areas
Minimum of five years of management experience with experience in strategic planning and developing and implementing strategies for achieving business objectives and organizing and managing multiple priorities, including extensive knowledge of operational execution issues relevant to the health care setting and related concepts
Supervisory experience required
Experience in working with technology platform development, including document-driven database structure, ICD codes, Java, ArcGIS 10+, and map stylization
Excellent interpersonal skills for building and fostering key relationship
Ability to establish credibility and be decisive and results oriented while balancing varying business considerations/priorities, as well as is the ability to demonstrate good judgment and critical thinking relative to problem analysis/resolution at both the strategic and functional levels
Exceptional leadership skills relative to staff management and achieving results through others and working in a shared leadership environment
Exceptional project management capabilities for the effective deployment of resources and achievement of multiple projects in a cross-functional environment
Demonstrated financial interpretive abilities and demonstrated proficiency to develop and manage large departmental budget and negotiate and manage departmental contracts
Excellent experience in operations process redesign, quality improvement, team building and systems integration
Exceptional strategic planning skills; abilty to take large-scale initiative and break down into manageable tasks
Excellent oral and written communication skills with the proven capabilities to negotiate, persuade, and make effective presentations to varying audiences internal and external to BCBSA
High level of confidence, integrity, flexibility, can-do attitude, and critical thinking skills, as well as a professional executive presence for interacting with and influencing key leadership and decision-makers within the BCBS system, as well as with external stakeholders
Prior experience with a national health care organization
Ability to build effective relationships with cross-functional teams, Plans and external stakeholders
Understanding and knowledge of the healthcare marketplace and the related regulatory environment, and a familiarity with the BCBS system and Plans is highly desirable

Director, Clinical Quality & Provider Liaison Resume Examples & Samples

Requires a BA/BS in a health or business related field; 10 years of experience in a healthcare environment, including prior management experience; or any combination of education and experience, which would provide an equivalent background
MSN, MPH, or MPA preferred. CQM experience in a Managed Care Organization strongly preferred
Population health management and/or clinical quality program development experience preferred
Health Plan, managed care organization or provider management group experience required
Schedule Expectations

Director, Clinical Alliances Resume Examples & Samples

Primary responsibility is to lead the CROs and collaborations on Akebia’s pipeline
Future collaborations on existing Akebia programs, and on in-licensed programs
Ensure that key goals for each alliance is achieved by the partners, oversee Akebia’s contractual obligations, and be the go-to person internally and for our partners for alliance-related matters
Work closely with and support cross-functional teams to prepare for interactions with our vendors
Drive and/or assist in the review and creation of inter-company communications and develop agendas, manage the vendor meetings and document the key discussion points and decisions taken at these meetings. Identify issues as they arise internally, or as a result of vendor interactions, and work with team leadership and other necessary stakeholders to formulate a position/strategy and participate/drive resolution process
Leverage a thorough understanding of the research, development and commercialization of new drugs through past experience, and be well grounded in the scientific, development, regulatory and commercial concepts inherent in both early and late-stage development programs
Work closely with a variety of functions, including but not limited to research, development, regulatory, commercial finance and legal to ensure that the relevant points of view from the key stakeholders are incorporated into all situations and analyses
MBA MSc or PhD a plus (not a requirement)
Minimum of five years relevant clinical research experience in a pharmaceutical company and/or CRO,
Extensive experience in project management and/or clinical operations, alliance governance and relationship management
Extensive experience in pharmaceutical alliance management across development stage: pre-clinical, clinical and pre-launch/commercial
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Excellent communication skills, with strong ability to build and communicate business rationale
Strong leadership, relationship management and negotiation skills
Ability and desire to work in biotech: small teams, fast pace, fast changing environment
Combination of strong strategic thinking with the ability and desire to implement tactical plans. (strategize and lead, but also execute directly)
Enjoy working in teams

Assoc.director / Director Clinical Sciences Resume Examples & Samples

Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSCs) based on thorough scientific review and consultation with internal and external experts
Has authored industry documents and/or has published in medical/scientific peer-reviewed journals. Interactions with Regulatory agencies or Common Technical Document (CTD or “dossier”) submission in any ICH region are an advantage
Demonstrated critical thinking skills and sound decision-making

Associate Director, Clinical Data Standards Resume Examples & Samples

Drives the vision for clinical data standards to effectively support Novartis' clinical research strategy, from collection through submission
Collaborates closely with Oncology Global Development, to ensure that Oncology standards packages are defined, measured, managed and used to improve efficiency and quality of clinical trial collection, analysis, reporting and submission
Represents the Oncology Business Unit on Data Standards Governance (DSG) committee to ensure core standards needs of the unit are met
Leads Oncology data governance process to ensure consistent data standardization is enforced across Development; overall accountability for the functioning of the Data Standards
Functionally manages staff supporting the development of new Novartis data standards
Initiates and leads business process changes in the context of data standardization as well as required capabilities to support standards education (new terminology, approach, and context) and training (data standards implementation, CDISC - ODM, SDTM, ADAM)
Works with external organizations to develop best practices and advance clinical data standards
Participates as a recognized Novartis leader to selected external data standards working groups within HL7, CDISC, and ICH
Provides input to and undertake the implementation and maintenance of global working practices and standards
Contributes to the development of the Clinical Data Management organization through his/her global leadership role on the management team
Represents Clinical Data Collection Standards at cross-functional forums, meetings and provide timely feedback to partners
Leads and supports clinical & non-clinical special projects
Supports the establishment of training programs (technical and professional skills) for Clinical Data Management staff and ensure staff training is conducted and properly documented
If required, deputizes for the responsibilities of the Operational/Functional Manager
Participates in Health Authority inspections as required Version –1.0_18Dec2015 Page 2
Where appropriate, ensures a mentor is assigned (including managers)
Ensures adequate resources are in place
Reports to Director if there are any additional unanticipated demand for resources Novartis is an Equal Opportunity Employer
Ideally 10 or more years’ experience in clinical data standards with at least 8 years in Clinical Data Management
At least 5 years' line management or global project team leadership experience
Strong technical and problem solving skills, and ability to evaluate computer systems to support clinical data collection standards/data management
Excellent understanding of clinical data collection standards CDISC, SDTM
Understanding of GCP

Director, Clinical Analytics Resume Examples & Samples

Required: Master's degree in biostatistics, statistics, Epidemiology, mathematics, or related field. Ph.D. preferred
Demonstrates the ability to conduct qualitative and quantitative research and to analyze data in order to produce publications
Possesses strong oral and written communication and interpersonal skills
Ability to effectively organize and manage multiple assignments with challenging timelines while maintaining high standards
Good understanding of experiment design: Control vs variations, factorial experiment design, multivariate experiments, simple random sampling vs stratified, etc
Evaluates effectiveness and return on investment (ROI) for various initiatives
Advance Knowledge of Designing and implementing epidemiologic studies to understand disease burden and health care services being utilized for disease diagnosis and treatment

Director, Clinical Data Solutions Resume Examples & Samples

Obtains/maintains knowledge of current HealthTrust, Physicians Advisory Services, and Clinical Data Solutions practices, relevant product knowledge in the medical device space, healthcare industry trends, managed care and reimbursement issues, and consultative practices
High energy and willingness to work in an environment where priorities and focus change routinely
Proficient in word, power point, excel and other office products
3-5 years of related healthcare management experience

Associate Director, Clinical Study Management Resume Examples & Samples

Reports to the Global Head of Clinical Study Management, is a member of the Clinical Study Management management team and contributes to the implementation of the Global Clinical Science mission, Clinical Study Management objectives and 1-3 year strategic plan
Contributes to the creation and use of an integrated single GDO set of standards, processes and tools for the execution of clinical trials in APGD
Responsible for the optimal development, allocation and management of Clinical Study Management resources to APGD study teams for the assigned therapeutic area(s)
BA/BS degree with at least 10 years clinical trial management experience; advanced degree (MS, PhD, PharmD) preferred with 7 years clinical trial management experience
Minimum of 4 years people management experience
Must have extensive expertise in developing operational strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
Must have extensive experience in people and project management, strategic planning and a strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management
Must have experience working across multiple molecules, indications and phases of development
Must have proven and effective interpersonal, leadership, written and verbal communication skills, administrative skills and computer ability
Fluent in English; low to moderate (5% to 20%) travel required

Director, Clinical Programs Resume Examples & Samples

Responsible for the HBR and HEDIS goals for the market and any work plans to address those goals
Participate in the implementation of new lines of business
Identify and propose recommendations for clinical initiatives to address utilization trends and Health Plan needs and monitor existing programs for effectiveness
Assist with review of departmental policies and procedures
Collaborate with health plan Medical Management departments and ensure goal alignment
Serve as the primary liaison with state contacts and stakeholders
Provide, interpret and communicate information and data to Health Plan and external stakeholders
Monitor performance results against established metrics and benchmarks and recommend improvement opportunities
Monitor utilization trends for intervention opportunities

Director, Clinical Biomarkers Resume Examples & Samples

Develop and implement fit-for-purpose clinical biomarker assays at external CROs to support biomarker driven global clinical trials
Evaluates vendor validation and clinical analysis plans
Provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements
Collaborates with Clinical Operations to ensure appropriate informed consent language for biomarker-related sample collection and evaluation
Serve as the departmental operations lead with the goal of streamlining and improving the clinical biomarker and companion diagnostic processes
PhD in biological sciences or related field with 8 or more years of related experience post degree. For individuals with a MS/BS 10+ years’ experience post degree
Experience working in a GLP or GLP-like environment highly preferred
Strong oral/written and interpersonal skills required
Strong organizational and networking skills

Director, Clinical Management Home-based Resume Examples & Samples

Supervises and coordinates Clinical Management functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables. Ensures the clinical teams are provided with the necessary support and resources to successfully deliver clinical deliverables
Ensures the timely execution of clinical deliverables with a focus on quality. Develops and drives the specific and overall project or program strategy to ensure optimum performance and achievement of annual plans and targets. Facilitates meetings to identify potential risks and works with the clinical team to develop and communicate contingency plans
Ensures risks to clinical deliverables and potential solutions are communicated through appropriate escalation pathways. Reviews and assesses clinical project or program finances and ensures risks are escalated appropriately with any information necessary for a contract modification
Manages clinical management resource levels including hiring and promoting, as appropriate. Participates in resource calls and ensure teams are provided with adequate levels of appropriately qualified resources
Inducts new managers to PPD. Provides performance appraisals, evaluates and allocates bonuses and merit increases, as appropriate. Develops and motivates through goal setting, ongoing feedback, formal evaluation, and effective delegation
Advanced leadership and management skills
Excellent interpersonal and problem solving ability
Expertise in negotiating and strong organizational skills
Excellent oral/presentation and written communication skills in the native language and in English
Ability to perform tasks required of a functional staff
Ability to successfully network with other Divisions (departments) where necessary
Strong knowledge of budgeting, forecasting and fiscal management
Demonstrated expertise in leading, motivating and integrating project teams
Self-motivated and possess good interpersonal skills and projects a positive attitude
Ability to effectively teach required skills
Excellent coaching and mentoring skills
Knowledge and understanding of clinical development regulatory guidelines and Directives
Ability to work effectively in a matrix organization

Medical Director, Clinical R&D, Solid Tumors Resume Examples & Samples

Lead the development of the clinical strategic plan for product/therapy area. Identify what is needed to drive the product/therapy area and the specific operational plan to get there
Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning
Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision
Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area
Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses

Regional Director, Clinical Transformation Resume Examples & Samples

Train on and support the use of technology and software applications utilized in the support of the ACO and/or HH program
Measure and communicate performance metrics and expectations at the employee, practice and region level
Prepare, read and disseminate ACO key performance reports, identify reasons for performance gaps, and identify opportunities for improved performance
1 year experience managing medical homes, Patient Center Homes or Accountable Care Communities
3 years of practice management / operations experience
Bachelor’s Degree in Health Informatics, Health Administration, Business and / or Public Health; Master’s strongly preferred

Director, Clinical Affairs Resume Examples & Samples

Provide clinical research strategies, evidence development plans and protocol development with cross-functional teams including Marketing, Health Economics, Regulatory and R&D
Provide data for dissemination to meet the needs for market registrations, clinical and product marketing and further device development
Lead a high-performing team to successfully drive these studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations along with company compliance requirements
Serve as group leader with product development and marketing leaders to set priorities
Provide input on strategic decisions and ensure clinical affairs representation in core team meetings and activities
Lead clinical scientific discussions with regulatory agencies, investigators and clinical thought leaders. Interact with Marketing, Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management
Leads and directs pre-market clinical affairs activities to ensure completion of all cross functional activities for product development activities. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development as clinical affairs team members
Oversees design and implementation of preclinical studies for product development stage medical devices
Drives setting of team goals and milestones; monitors progress
Represents the study team and/or department during meetings with senior management, FDA, and other global regulatory authorities, business or functional groups
Requires 10+ years directly related experience in clinical/scientific experience including leadership or management role within device industry
Requires 5+ years' experience in managing a clinical research functional team with proven track record in delivering complex clinical programs on time, within budget, and in compliance
Comprehensive understanding of applicable clinical research regulations in multiple regions
Requires 5+ years' experience in conducting preclinical studies with development-stage medical devices
Experience interacting with top-level executives
Knowledge and experience with FDA device regulations, writing FDA reports, medical device clinical trial practices, GCPs and elements of Informed Consent. In-depth knowledge of medical device development regulatory requirements needed
Demonstrated ability to build collaborative relationships with key internal and external stakeholders
Ability to lead and influence through direct and indirect resources to shape organization
Meticulous attention to detail and accuracy required
Demonstrated ability to manage multiple studies, staff and company initiatives effectively
Ability to represent the Company at professional and business functions in a competent manner
Develops and implements effective solutions to a variety of problems; ensures solutions are consistent with organizational objectives
Experience with medical devices used in a catheterization lab
Practical experience with clinical research studies, in the cardiovascular, peripheral vascular or electrophysiology medical device applications in a sponsor company, or equivalent
Lead and shape change in team settings
Will supervise exempt and nonexempt employees, with a variety of scientific backgrounds
Participates in hiring, goal-setting, performance evaluations, termination, promotion and merit decisions

Senior Director Clinical Services Resume Examples & Samples

Drive positive DQI trends within the division
Monitor and report on AOR investigation process within the division
Monitor implementation and report on company initiatives
Ensure that all new clinical teammates complete the appropriate DaVita Prep training program
Ensure the timely completion of clinical training
Direct the implementation of training materials/revisions from the national education team
Ensure adherence to the DaVita compliance program
Ensure division's compliance with all laws, regulations and practice guidelines that impact nursing practice
Provide coaching and leadership including effective performance feedback to Clinical Services Specialists and Clinical Trainers
Ensure the team is providing support for and development of the clinical preceptors
Participate as a member of the Divisions Operations Management Team in development of strategic direction for division and ensure the development of outcome programs to support the direction
Participate in the divisional operations review process and provide reports with analysis as requested
Strong communication skills, both written and oral
Demonstrated ability to manage and mentor people
In-depth understanding of facility operations and the roles of direct caregivers in mission accomplishment
Ability to seek creative solutions to the challenges of adult learning and education and continuing education

Assistant Director, Clinical Services Resume Examples & Samples

Oversees all aspects of the direct clinical services provided by MHS, including: intakes and other assessments; individual and group counseling; crisis intervention; case management; record keeping and documentation; consultations; compliance with ethical and legal standards of care; orientation and training of new staff regarding clinical services provisions; the revision and maintenance of MHS’s manual of policies and procedures
Serves as a member of the MHS leadership team. Participates in strategic planning and goal-setting relation to MHS services, program development, and resources allocation; review and development of policies and procedures; administrative supervision of clinical staff; recruitment and hiring of staff; creation of annual and other reports; and other activities affecting the effective and efficient functioning of MHS
Provides clinical services, including individual assessment to determine treatment recommendations, brief counseling interventions, testing, group counseling and referral services
Participates in outreach services to meet the mental health needs of the University community, including academic support programs, educational workshops, personal skill development groups, consultation and training programs for faculty and staff
Conducts crisis interventions and debriefings as necessary
Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position

Director, Clinical Technology Management Resume Examples & Samples

Solution Oriented approach, proactive thinking skills to troubleshoot and provide optimal service
Ability to provide world class service to our customers
Superior business acumen and budget management proficiency
A great leadership track record exceeding delivery expectations
Successful business driver delivering on business vision
Formal training and preferred experience servicing Senior BMET level Equipment
Prior experience and success in a Clinical Technology Senior Technician role to include medical imaging hands on service as well as General Manager experience within hospital or health care settings

Director, Clinical Technology Management Resume Examples & Samples

An outstanding management performance record within Health Care Technology and a broad understanding of the many service aspects that they will encounter/resolve day to day
Cultivate and sustain a client/customer-centric operating culture that strives to exceed client goals, objectives, requirements and expectations
A leader with unwavering ethics, integrity, and related personal attributes who will inspire team members to develop to their fullest potential
The ability to be responsive, organized, resourceful, adept at making decisions, and serving as visionary with strong service focus
Proficient at managing budgets and finances of the department
Strong background in both imaging and general biomedical equipment service

Director Clinical Data Solutions Resume Examples & Samples

In-depth, up-to-date knowledge of medical specialties covered by Clinical Data Solutions
In-depth, up-to-date knowledge of healthcare economics
Strong organizational skills, including the ability to plan, implement, follow up, the ability to focus and exceptional time management with minimal oversight
Ability to work effectively as a team member in a remote environment
Complete professionalism including the qualities of confidence, motivation, accountability, integrity, and humility
Sense of vision, creative imagination, and motivation towards the future of healthcare
Ability to work in home office environment, work with remote teammates
Current licensure/registry in healthcare related field

Director Clinical Services Resume Examples & Samples

Developing, implementing, evaluating, supervising and managing all aspects of hospital-based and outpatient behavioral health and substance abuse social work programs
Responsible for oversight of and provides supervision to non licensed Social Workers and interns
Responsible for documentation of individual, group and family therapy with final endorsement authorization
Provides social work and case management services for patients as needed
Completes psychosocial assessments, discharge/aftercare planning and assists in the development of treatment plans and liaisons with community resources
Provides case management to assigned patients and provides group, family and individual therapy as prescribed
Builds relationships with the behavioral health community through referral development and marketing contacts
Identifies behavioral health needs in the communities served by the hospital and works collaboratively with senior management in program development
Provides direct supervision and clinical oversight for social work services

Director, Clinical Services Resume Examples & Samples

Atleast 10 years of experience
Minimum of ten years’ clinical experience in case management and/or renal services
Minimum of three years’ management and/or administrative experience
Minimum of two years’ project management and/or project implementation experience
Intermediate proficiency in MS Word, Excel, PowerPoint, & Outlook&#8217

Director, Clinical Quality Resume Examples & Samples

Oversees the development and implementation of plan quality program as per the RFP requirements
Works to coordinate the work within Centers of Excellence for: HEDIS Data Collection, Data Analytics and Reporting, Accreditation, Member Surveys, Regulatory Adherence, and Member Activation and Engagement
Utilizing the expertise, standard process, and capabilities of these areas to enhance quality program performance of the plan
Directs as applicable quality improvement activities and interventions to close gaps in care and improve outcomes for identified critical quality measures
Ensures strong HEDIS performance
Insures the creation, integration, maintenance, approval, and submission of the trilogy document, including but not limited to Quality Program Description, Work Plan, Evaluation, and Program Policies and Procedures
Insures the creation and submission of reports to meet state contractual requirements including Performance Improvement projects (PIPs)
Directs as applicable process improvement plans and corrective action plans for surveys, accreditations, EQROs, and state audits, within the scope of Quality Management and Improvement
Represents and gives input to the RFP process as it applies to quality
BSN required, Advanced degree a plus
Current RN license in Missouri required
CPHQ required or commitment to obtain certification within 6 months of hire
5 years’ management experience

Associate Director, Clinical Quality Resume Examples & Samples

Quick identification and efficient issue resolution
Ability to influence others and build strong professional relationships
Aptitude to drive profitability/Improve performance and lead an integrated/matrixed core service
Quality Management/Regulatory Adherence
Employee Engagement and Development
Oversee the development and implementation of plan quality program in conjunction with the Senior Quality Director
Coordinate the work within business segment partners on HEDIS Data. Collection, Data Analytics and Reporting, Accreditation, Member Surveys, Regulatory Adherence, and Member Activation and Engagement. Utilizing the expertise, standard processes, and capabilities of these areas to enhance quality program performance of the plan
Partner to develop Quality Improvement plan playbook and achieve quality targets
Direct as applicable quality improvement activities and interventions to close gaps in care and improve outcomes for identified critical quality measures
Ensure strong HEDIS performance
Collaborate across business segments to attain or maintain the Plan’s compliance with accreditation standards and contractual requirements as they apply to quality
Maintain positive relationships with State Agency stakeholders and State External Quality Review Organization within the scope of Quality Management and Improvement
Ensure the creation, integration, maintenance, approval, and submission of the trilogy document, including but not limited to Quality Program Description, Work Plan, Evaluation, and Program Policies and Procedures
Direct the creation and submission of reports to meet state contractual requirements including Performance Improvement projects (PIPs)
Manage the Health Plan Quality Management /committee structure and integrated quality oversight processes
Run as applicable process improvement plans and corrective action plans for surveys, accreditations, EQROs, and state audits, within the scope of Quality Management and Improvement
Represent and give input to the RFP process as it applies to quality
Interview, hire, and supervise quality department staff
3+ years of experience in leading an integrated and progressive quality organization, preferably within health care industry
3+ years of significant leadership and managerial experience
3+ years of experience with demonstrated functional knowledge, process improvement initiatives and organizational behavior

Associate Director, Clinical Services Resume Examples & Samples

Establishes strategic priorities for Utilization Management and overall affordability initiatives
Identifies and analyzes local trends, service gaps and the development of mitigation strategies aligned with our strategic priorities
Responsible for defining and developing local market-specific mitigation strategies in coordination with clinical operations functional leads, Affordability, Finance and other matrix partners
Monitors and oversees performance against both utilization and financial targets to ensure targets are met
Serves as Clinical lead in monthly / quarterly stakeholder and ad hoc state meetings
Collects, and delivers required clinical operations, service reporting as well as develops action plans to address performance issues
Collaborates and coordinates with state, providers and other stakeholders in conjunction with the Executive Director and Provider Relations Unit
Ensures the timely completion of all clinical contract deliverables
Supervises and collaborates with the Clinical manager in the effective delivery of services and to ensure utilization and enrollee goals are met
Demonstrates an effective, adaptive leadership style that promotes innovation and accountability and establishes work priorities
Acts as the primary BH clinical source for the State and other Stakeholders to address routine and complex member issues / concerns. Is a physical presence in the community with community providers, state agencies, advocacy agencies / groups
Leads and / or participates in local / state clinical projects that result in the development or improvement of local clinical services and / or access to care
Interfaces routinely with Provider Network to ensure access to care meets the needs of the enrollees
Conducts / attends ad hoc trainings with provider community as requested
Leads and / or participates in provider forums as needed
Possesses an active, independent, and unrestricted behavioral health licensure and certification from the state or board which issued the credentials required
Minimum of 5 years of experience working in a clinical health care environment required
3+ years of leadership and administrative experience in public sector or BH care required
Understanding of managed care principles preferred
Prior experience in public sector mental health or behavioral health, with knowledge of Medicaid populations strongly preferred
Demonstrated leadership effectiveness and project management experience
Strong report writing capability
Strong data analysis and PC proficiency
Master’s degree in social work, psychology, counseling or related field
Experience in a recovery-oriented delivery system a plus

Director Clinical Affairs, Infectious Disease Resume Examples & Samples

Provide comprehensive support of all operational aspects of clinical studies including the review and approval of protocols and study-related documents such as regulatory binders, work instructions, CRF development and completion guidelines, monitoring reports, and clinical study reports, etc
Develop goals and objectives for department members consistent with over-arching corporate goals and strategic imperatives. Provide feedback and evaluate performance on regular basis. Prepare and manage department merit budget
Have good knowledge of and experience with the requirements of FDA and regulatory bodies outside the US for clinical validation of in vitro diagnostic (IVD) products
Participate in Clinical Research Organization (CRO) selection process for outsourced activities as applicable
Direct and oversee CRO activities including study management, site monitoring, data management and study master files as applicable
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Director, Clinical Risk Management Resume Examples & Samples

Responds to queries from corporate and center staff regarding clinical risk issues. Triages medical/legal inquiries regarding emergent patient care issues and loss control
Assist or consults with legal counsel as needed
Other duties as assigned. This position reports to the Vice President, Clinical Risk Management
Customer Focused:The ability to create an environment in which a positive and professional attitude is always exemplified. This includes the ability to understand and anticipate physician, center director, clinical director, and operations staff needs, and to meet and exceed their expectations. To maintain trusting relationships is vital to this role, but must be done with open and candid communication and consistent follow-through while maintaining confidentiality
Ethics /Confidentiality:The Director of Clinical Risk Management will “practice the profession with honesty, fairness, integrity, respect, and good faith”. He/she will maintains the confidentiality of all pertinent patient, center, and company information
Adaptability/Flexibility: Ability to rearrange schedules to meet the needs of the surgery centers and teams and respond quickly to situations created by untoward incidents or unanticipated problems
Initiative/Self Reliance:Ability to look for better ways to organize time and the demands of several levels of customers; pro-actively seeking ways to improve efficiencies and use technology to better meet the needs of the teams, physicians, and corporate colleagues. Refusing to settle for unsatisfactory or incomplete answers and pro actively/creatively seeking information needed even when it is not readily available
Builds Effective Relationships: The ability to develop and maintain positive working relationships with corporate and ASC staff. To remain calm and in control and demonstrate leadership during potential conflict situations. To present oneself in a positive manner, including being predictable, consistent, and at ease. This also includes being aware of and valuing the diverse cultural, ethnic, gender, age, etc., background of others and the ability to adapt interpersonal style accordingly
Produces Results: Directs action toward achieving goals that are critical to Department and Corporate success
Communication Skills:The ability to speak clearly and succinctly to all levels of customers using a pleasant and courteous tone and language. This includes the ability to convey information clearly to coworkers, supervisors, customers, etc., and actively listen to and understand key pieces of spoken information, separating relevant from irrelevant information and following oral instructions and explanations
Critical Thinking:The ability to actively conceptualize, analyze, or evaluate information gathered from observation, review, experience, or communication
Detailed: The ability to gather vital information; document the information in the appropriate format and to appropriate people at both the corporate and ASC level and to ensure the information/files are complete and secure

Director, Clinical & Quality Solutions Resume Examples & Samples

Responsible for new product development and growth of the HEDIS business
Provides sales support as a SME and drive growth strategy
Work with the leadership team to execute on the HEDIS business roadmap
Collaborate with Marketing to appropriately position the business within the market
Represent the business at industry events & develop reputation as an expert
Coordination with Sales team to ensure alignment on growth strategy
3+ years experience being in a senior leadership role in Quality (e.g. Director of HEDIS / Stars)
Ability to support sales and service of new product development
Expert level presentation / public speaking skills
Be able to manage and prioritize large projects with great visibility
Have expertise in health plan operations, especially around HEDIS
Understanding of CMS Five STARS, NCQA HEDIS, etc

Executive Director, Clinical Applications IT Resume Examples & Samples

Lead and manage a large and complex portfolio of Clinical Applications including IT resource teams associated with that portfolio
Construct and execute strategic and tactical plans to carry out the organization’s objectives
Construct and execute short and long term road maps for the assigned portfolio of applications
Partner with institute operational and business leader to understand and drive vision
Utilize appropriate methodology to accomplish objectives
Support and partner product transitions between high-velocity and operations
Actively drive and participate in Clinical Governance
Regular Executive report out to various levels of Executive Management
Recommend and resolve prioritization conflicts across initiatives
Understand hospital strategy and clinical vision and translate clinical vision into executable initiatives
Provides executive leadership support over the activities of managerial, technical and other support staff
Develops and maintains overall IT strategy and roadmap of functional area. Identifies, monitors and communicates relevant metrics and performance for their business unit
Participates as key member of IT executive senior leadership team to promote collaboration and prioritization of enterprise initiatives across the Division
Interprets and communicates Foundation, Divisional and System wide policies and procedures
Functions as an executive partner by building relationships with customers that could include Division/Institutes/Hospital executives, physicians and external partners
Overall financial responsibilities of assigned functional areas. Establishes, maintains, monitors, and reports expense budgets within corporate financial policies using accounting budgets, standards, guidelines and tools supplied by the corporate finance function
Reviews and develops improved operational systems, including computer system acquisitions, space and equipment allocation, office systems and procedures, manpower planning and allocation, patient safety, cultural diversity issues and other operational procedures or programs
Performs or directs the performance of systems analysis to create improved operational efficiencies throughout the Division
Responsible for overall employee engagement and professional development. Provides advice in the hiring process, counseling of employees, defining expectations, monitoring productivity, performance evaluation and management
A minimum of 15 years of functionally related experience, including at least 7 years of progressive management experience
Demonstrated ability to work in a fast-paced environment and be flexible and agile to meet business objectives
Possesses Serving Leadership skills beyond technical expertise leadership
Experience creating and leading large teams
Experience in a large complex organization at a Senior Management level
Experience with EMR/EHR preferred
Experience with EPIC preferred

Associate Director, Clinical Data Review Resume Examples & Samples

Identify opportunities, and implements solutions to globalize and standardize methods, processes, procedures, systems and templates within the Clinical Data Review department
Execute data review strategy to meet needs of program/protocol
Manage Clinical Data Reviewers including the managing of study assignments and the allocation of workload as appropriate for the group
Evaluate resource gaps and creates headcount requests and justification
Select, manages, and develops/coaches direct reports
Works with direct reports to set performance objectives, drives talent review and promotion planning for direct reports
Will develop and maintain processes that align clinical data review activities across all applicable functions. Similarly, this individual will ensure the development of training material that supports Clinical Data Review needs
Is responsible for supporting global inspection readiness and inspections in regards to Clinical Data Review processes
Ensure the development of technological support for Clinical Data Review
Represents Clinical Data Review on cross-departmental projects and continuous improvement initiatives and other ad hoc multidisciplinary teams as required. Contributes to developing strategies for and implementing ongoing improvements within GDSS
Evaluates personnel development and training needs; facilitates orientation and implements training
Create departmental metric reports and facilitates interpretation of metric information. Identifies strategies for use of metric information to clarify issues, develops/evaluates best practices
Passion

Director Clinical Services Resume Examples & Samples

Developing, implementing, evaluating, supervising and managing all aspects of hospital-based and outpatient behavioral health and substance abuse social work program to ensure quality services through efficient use of hospital resources and in accordance with hospital policies and procedures, discharge/aftercare planning and liaisons with community resources
Responsible for the oversight of and providing supervision to non-licensed social workers and interns
Responsible for documentation of individual and group family therapy with final endorsement authorization
As needed, provides social work and case management services for patients throughout the facility
Identifies behavioral health needs in the communities the hospital serves and works collaboratively with senior management in program development to meet these needs for the same program

Director, Clinical Technology Management Resume Examples & Samples

BA/MS Degree preferred
10 years experience in management of Biomedical/Clinical Engineering Programs
Recent experience in managing a comprehensive service program

Director, Clinical Affairs Resume Examples & Samples

Requires a minimum of a bachelor's degree in a scientific discipline, advanced or professional degree desirable
Knowledge and experience with global medical device regulations, writing reports, medical device clinical trial practices, GCPs
In-depth knowledge of medical device development regulatory requirements needed
Demonstrated management and cross-functional collaboration skills
Ability to effectively lead, drive talent development, and influence through direct and indirect resources to shape organization globally
Demonstrated ability to manage multiple projects, staff and company initiatives effectively

Consulting Director, Clinical Patient Access Resume Examples & Samples

Current permanent U.S. work authorization
A minimum of 10 years of relevant experience leading teams in the delivery and implementation of large complex performance improvement engagements
Minimum of 4 years of recent experience in a process re-engineering consulting firm environment with subject matter expertise in hospital patient access, clinical operations and/or revenue cycle
Current experience with healthcare HIS/EMR systems, i.e., Epic, McKesson, Cerner, etc
Current formal complex project management experience using a defined methodology (Lean/Six Sigma or
Extensive experience leading the delivery of large, complex consulting projects with healthcare providers in patient access, clinical operations, and/or revenue cycle process re-engineering
Proven success managing large teams and complex projects (creating work plans, budgets, goal setting)
Supervisory and team development experience, including the development and delivery of performance evaluations, coaching and mentoring on a day-to-day basis
Able to demonstrate solid negotiation skills and the ability to effectively manage client expectations for engagement deliverable s in order to meet or exceed objectives while maintaining budget
Multi-task across directing multiple concurrent projects, leading teams, managing clients, identifying new business opportunities and developing people. Demonstrated ability to deal with ambiguity and make sound decisions
Strong attention to detail and proven data/analytical and process redesign skills (including problem solving, quantitative reasoning and workflow mapping) in order to oversee the team�s analysis and process improvement recommendations to create a solution that drives measurable desired results and maintains client and team satisfaction
Exceptional organization and time management skills to manage multiple priorities at once with fast-paced turnaround times
Solid written communication and documentation skills to create and edit internal and client deliverables that are succinct, articulate and meet Huron�'s standards of quality
Excellent interpersonal, verbal communications and presentation skills
Advanced knowledge of MS Office programs and tools

Director, Clinical Data Solutions Resume Examples & Samples

Current licensure/registry in healthcare related field, RN Preferred
Recent CCL or CVICU experience preferred
Charge Nurse experience preferred

Director, Clinical Programming Resume Examples & Samples

Oversight for Clinical Programming and Technical Solutions groups
Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc
Develop and implement a programming request tracking systems. Track, analyze, and report on internal programming requests and clinical programming key performance indicators, metrics, and program level deliverables and timelines
Oversight for Data Standards efforts, Process and Training
Contributes to project budget/resource planning, re-forecasting, program milestones, along with DM & Programming leadership
Experience in working in cross-functional, multicultural and international clinical trial teams
Minimum 10 years (5 years supervisory/leadership) experience in a pharmaceutical/biotech setting preferred
Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC (SDTM, ADaM, SEND) requirements
Excellent interpersonal, organizational, and multi-tasking skills

Medical Director, Clinical Affairs Resume Examples & Samples

Support the generation of clinical development strategies
Responsible for the creation of clinical development plans for both pipeline and approved products
Work closely with Clinical Operations to ensure the successful execution of sponsored Phase 1-4 clinical trials
Participate in the design of sponsored clinical trials including the development of study protocols in close collaboration with the cross-functional study teams
Provide input to the selection of investigators
Present at Investigators Meetings
Provide medical oversight to and serve as medical monitor for sponsored clinical trials
Provide medical review of clinical trial data
Provide input to regulatory documents and submissions
Support Clinical Affairs budget planning and management
Maintain high level of expertise of the relevant disease areas and serve as medical resource for specific projects
May support business development due diligence as needed

Director, Clinical Risk Management Resume Examples & Samples

Support the Company's strategic quality objectives, including the reduction in readmissions and patient harm, by identifying the risk factors and causes of patient injury, and ultimately the basis for monetary outlay related to resolution of patient injury claims; communicate findings/results to other stakeholders within the Company; participate in the development, implementation and management of the Company’s clinical initiatives
Serve as the primary tool for new Risk Manager on-boarding (both in existing hospitals and new acquisitions), as well as providing risk management education to existing personnel
Support ongoing hospital operations by serving as a day to day resource to the hospitals on all risk management issues
Provide support, research and consultation to the Risk Department through claims investigations, due diligence, operational assessments and other risk management and insurance issues

Associate Director, Clinical Trial Operations Resume Examples & Samples

An advanced research professional responsible for the effective and efficient clinical trial operations provided in Duke affiliated oncology and network service programs, ensuring protocol specific requirements can and are met at each site for each protocol. This is achieved through
Establishing effective relationships with Duke Investigators and Duke study teams to allow for access to Duke Investigator Initiated Trials (IITs)
Ensuring site capabilities to effectively manage clinical trials
Effective relationship building and collaboration with all parties involved in the administration of Duke-affiliated research programs
Coordination of research activities in compliance with contract terms of each affiliated program
Effective management of DCN research team employees, allowing team members to perform at their highest level
Experience in conducting clinical research
Progressive supervisory or program management experience
Knowledge of HHS and FDA human protection regulations
Certification in Clinical Research strongly recommended (SOCRA, ACRP)
Ability to analyze trends and data and to present findings to various stakeholders
Interviewing Skills
Excellent problem solving skills
Ability to multitask is essential
Highly organized with attention to detail
Computer literacy and the ability to understand complex databases (Access, REDCap, electronic research management systems)
Teaching and mentoring abilities
Supervisory experience and skills
Ability to travel to affiliated sites (mainly within 4 hour drive or short flights on small planes, some regional and national overnight travel will be required)

Director Clinical Quality Resume Examples & Samples

Oversees the development and implementation of plan quality program
Works to coordinate the work within the QMP Centers of Excellence for: HEDIS Data Collection, Data Analytics and Reporting, Accreditation, Member Surveys, Regulatory Adherence, and Member Activation and Engagement. Utilizing the expertise, standard process, and capabilities of these areas to enhance quality program performance of the plan
Partners to develop Quality Improvement plan playbook and quality targets
Oversees and directs as applicable quality improvement activities and interventions to close gaps in care and improve outcomes for identified critical quality measures
Develops and maintains positive relationships with State Agency stakeholders and State External Quality Review Organization within the scope of Quality Management and Improvement
Oversees and directs as applicable process improvement plans and corrective action plans for surveys, accreditations, EQROs, and state audits, within the scope of Quality Management and Improvement
BS/BA in related field – advanced degree a plus
8-10 years of experience in leading an integrated and progressive quality organization, preferably within health care industry
8+ years of significant leadership and managerial experience
8+ years of experience with demonstrated functional knowledge, process improvement initiatives and organizational behavior
Performance Driven
Excellent written and oral communication skills with internal and external partners and employees
Strong change management experience and demonstrated skills
Results-oriented
Expert knowledge of the managed care/health insurance industry, products and services (preferred)
CPHQ preferred

Associate Director, Clinical Programming Resume Examples & Samples

Leadership responsibilities for internal programming and ad-hoc requests for Alkermes clinical programs from database start-up through database lock and CSR/submission
Manages programming relationships specific to metrics and dashboards, data cleaning, ad-hoc reporting, data review, data surveillance and data mining via strategic partnerships with preferred vendors
Oversight of programming specifications, templates and documentation in accordance with ICH/GCP guidelines and current regulatory requirements
Provides support and consultation to Data Management in review of key documents such as data validation specifications and listing programs, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc
Drive the development of Data Visualization tools providing information about data quality, study metrics, etc
Liaise with Technical Solutions group on initiatives including system integration, data transfer and sharing, access and storage. Lead and/or support other initiatives such as Data Review, Risk Based Monitoring, Data Standards, Coding and Lab review
Assists in development of Clinical Standards templates including eCRFs, edit checks, table shells, clinical data archiving, etc
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
Science and/or Computer Systems/IT background; MBA, advanced degree and / or PMP certification preferred
Minimum 10 years (3 years supervisory/leadership) experience in a pharmaceutical/biotech setting preferred
Advanced experience in programming tools such as SAS, R, PL/SQL, Perl, Python, etc.; technical expertise in databases, EDC platforms, data imports/integrations preferred

Associate Director Clinical Study Management Resume Examples & Samples

BA/BS degree with a minimum of 10 years clinical trial management experience
Minimum of 4 years people management experience
Must have extensive expertise in developing operational strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
Must have extensive experience in people and project management, strategic planning and a strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management
Must have experience working across multiple products, indications and phases of development
Must have proven and effective interpersonal, leadership, written and verbal communication skills, administrative skills and computer ability
Fluent in English; low to moderate (5% to 20%) travel required
LI-TW

Assistant Director, Clinical Pharmacokinetics Resume Examples & Samples

Independently conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions
Generates new PK/PD study proposals and leads those efforts
Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies
Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives
Responsible for leading Clinical Pharmacology/PK/PD aspects of multiple projects
Responsible for critically evaluating technical and scientific aspects of all AbbVie projects along with Clinical Pharmacology and Pharmacometrics (CPPM) management
Independently conducts due diligence
May manage personnel (PK Associates through Group Leaders) including development, mentoring, and effective delegation
Provides expert PK/PD/ Clinical Pharmacology and strategic consultation to GPRD, GPRA, and all levels of management on critical decisions and development plans for multiple projects within or across multiple therapeutic areas
Develops productive collaborations and communications with other groups across multiple disciplines
Highly effective writer and communicator of Clinical Pharmacology research or other regulatory materials
Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers
Serves as liaison to other departments /divisions for any study/project needs
Contributes to commercial and regulatory strategies by leading and formulating complicated Clinical Pharmacology plans including development activities
Develops Clinical Pharmacology plans, timelines and priorities of studies to satisfy regulatory expectations and defends plans and interpretation of data to regulatory agencies
Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information including use of therapeutic area databases
Is the Subject Matter Expert for Clinical Pharmacology interpretations of reports for regulatory filings and clinical protocols
Provides critical interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions. Is the primary author in high-impact factor peer-reviewed journals, R&D reports, and/or regulatory documents/filings
Manages of one or more Clinical Pharmacology programs, including personnel development, mentoring and effective delegation to direct reports to meet goals
Uses an external information network to gain competitive intelligence and act as advocate for integrating this knowledge into the project team's research efforts
Independently leads PK/PD activities and multiple major projects
Analyzes the impact of PK/PD decisions on projects and programs
Understands strategic objectives of projects and programs
Reviews key decisions impacting Clinical Pharmacology, PK/PD timelines with department management
Assumes a high level of responsibility in setting and achieving CPPM and GPRD goals
Provides input to overall drug development strategy and project timelines to assess project opportunities
Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance)
Has a strategic focus on projects, sets Clinical Pharmacology strategy and optimizes execution
Demonstrates a high degree of responsibility in maintaining CPPM standards, GxP compliance, and operating practices for self and reporting staff
Independently identifies and communicates issues and opportunities
Guides formation of Clinical Pharmacology strategy and tactics
Keeps accurate and current records of project activities according to AbbVie policies
Advanced knowledge of and experience in multiple therapeutic and/or functional areas
Experience across range of development phases preferred
Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion
Knowledge and understanding in application of standard business procedures (regulatory guidances, global regulations, ethical issues associated with clinical studies, SOPs)
Must have demonstrated exemplary PK/PD experience in managing and completing multiple complex projects or equivalent experience
Experience in multiple therapeutic areas or disease state/indications desirable
Proven track record of successful projects (report/submissions delivered on time, high quality)
Participated in and is key contributor to initiatives and advancement of CPPM as an organization
Builds/drives inter-department relationships and teamwork. Anticipates and leads issue resolution
Identifies opportunities for, and leads teams for process improvement initiatives
Actively participates in risk assessment and development of contingency plans
Connects scientific and business implications from multiple teams and links to overall strategy

Senior Director, Clinical Sciences Resume Examples & Samples

Provides multidisciplinary, scientific leadership across multifunctional project teams
Provides scientific knowledge and expertise for the clinical research aspects of the project , with a strong working knowledge of regulatory affairs, project strategy, and clinical development
Serves as key clinical research representative for products in development at strategic meetings/advisory boards
Provides clinical scientific input to the core documents for the project (e.g., product strategy documents, target product profile, protocols, submission, etc)
Develops, executes and regularly maintains the project clinical plan and other relevant clinical documents that are consistent with the project goals
Consults with internal/external stakeholders and internal/external key opinion leaders to validate the clinical scientific components of the clinical plan
Works closely with the clinical operations group, and provides strategic and scientific direction to support timely and on budget development and execution of the clinical development program
Serves as the clinical representative with investigators and regulatory authorities
Develops and gains approval by senior management for study protocol outlines and study plans created by the clinical project team
Participates and supports the clinical study team in site selection/evaluation including site training and to provide sufficient scientific knowledge for educating the study team and investigators and explain the scientific background and justification of a study/project
Plays a role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to needs and clinical utility represented in the project development strategy
In developing the study synopsis, complete study protocol, case report forms, statistical plans, blinded independent evaluation protocols, etc
In reviewing the clinical study documents such as protocols, CRFs, SAPs, etc
In conducting blinded independent evaluation
In problem solving
In providing clarification on protocol requirements and entry decisions
In developing team competencies
In providing input to operational team members who will execute the studies
In adhering to the timelines
In delivering high quality medical science resulting in high quality efficacy and safety data
In bringing relevant matters, including monthly reports, to the attention of relevant stakeholders as required
Provides scientific interpretation of efficacy and safety data and seeks advice of other experts as required
Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. Serves as the main scientific representative during these interactions, with support from other project team members as needed
U.S. licensed Medical Doctor (MD or equivalent qualification) preferred, including research experience; PharmD or PhD acceptable
The ideal candidate must have at least 8 (Director) or 12 (Senior Director) years of clinical research experience (primarily phases 2-4) working for a pharmaceutical, biotechnology, or CRO company
Knowledge of GCP, Clinical research, Fundamentals of Project Management, working in a matrix-based environment is a must
Demonstrated ability to lead people
Ability to operate independently with minimal supervision and will possess past Clinical experience which includes: literature analysis, providing input to the design and writing of clinical protocols, clinical reports, clinical development plans, CRFs, and other documents supporting clinical development and regulatory submission; ability to perform background research, review and evaluate clinical data in the generation of study concepts, protocols, reports, development plans and IND/NDA or ANDA submissions
Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH are necessary
Excellent written and oral communication skills and a command of the English language are a must
Organizational and cross functional collaboration skills
Approximately 10 to 25% domestic and international travel is required
Proficient in Microsoft Office (i.e., Word, Excel, SharePoint and PowerPoint)

Senior Director Clinical Affairs Resume Examples & Samples

Develops and implements strategies for clinical trials
Directs the design, planning, execution, and interpretation of clinical trials/research and the data collection activities
Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports
Monitors adherence to protocols, standard operating procedures and determines study completion
Develops and maintains good collaborations with premier scientists in the field, in order to monitor priorities in the field, identify outstanding questions, and to review the literature to identify policy questions, or to predict market developments
Reviews pertinent literature, prepares white papers, and provides education to Cepheid staff as needed
Monitors developments in the field of interest in order to be able to assess competitive activity, market development, and to identify opportunities to broaden service utilization
Manage the budgeting and planning necessary to support this department
Review both clinical and analytical sections for regulatory submissions
Interact with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO) authorities regarding clinical research in support of product registration
Provides leadership and mentorship to others especially those in the Clinical Affairs group
Play a role in the support of, and access to, Cepheid’s products in a diverse group of Private, Public, Federal and State payers regionally (Managed Care encompasses HMOs, third party payers, GPOs and IHNs), to ensure end-user access and secure rapid introduction and uptake of new products
Interacts internally and externally with executive-level management requiring negotiation of extremely difficult matters to influence policymaking bodies both internally and externally
Masters or PhD or equivalent experience
10+ years of relevant experience
Have a proven track record in obtaining FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, either in cancer or infectious disease diagnostics
Must have demonstrated accomplishment in obtaining diagnostic product clearances/approvals through U.S. FDA, and successful audits/inspections of clinical evaluation sites
Ensures budgets, schedules, and performance requirements are met
Requires the ability to change the thinking of or gain acceptance of others in sensitive situations
Previous management or project experience
A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology

Senior Director Clinical Statistics Resume Examples & Samples

Lead Data Monitoring Committee activities as an independent and a DMC Statistician
Perform clinical trial design, sample size determination, preparation of randomization schedules, statistical analysis, interpretations of statistical results, and preparation of statistical sections for clinical study reports
Evaluate and recommend appropriate statistical methods for data analysis
Provide support for submission applications being sent to regulatory authorities
Give advice to clients in all dealings with statistical issues as they pertain to submission and approval activities during the entire life cycle of product development
Support post marketing strategy and implementation providing leadership in assuring quality for all statistical deliverables
Develop and mentor staff
Master's degree in Statistics/Biostatistics
Minimum 12 years' pharmaceutical industry experience with expertise in statistical analyses and design of clinical trials across multiple statistical methodologies
PhD. degree in Statistics/Biostatistics
Supervisory/staff management/leadership experience
Development of statistical analysis plans
Understand CDISC standards and Adam Data Structure
Thorough knowledge of regulatory submission process
Experience interacting (direct or indirect) with the FDA

Director, Clinical Documentation Operations Resume Examples & Samples

Ensure a sustainable model is in place to build capability in the organization and drive excellence in the creation and delivery of a TMF that meets regulatory needs for every clinical trial conducted in GSK
Be accountable for the business process and associated written standards and training strategy
Ensure that the Pharma TMF Reference Model and the associated zone content is aligned with current and future thinking, internally and externally. Engage with a network of Zone Leads to drive best practices in utility and currency of the model across the end-to-end clinical development process
Represent Pharma on the Pharma/Vaccines TMF Business Process Governance Team to ensure consistency in working practices and alignment on continuous improvement
Partner with Clinical Development Quality Assurance to create and operationalise a TMF Inspection Readiness Support team that guides study teams preparing for regulatory inspections
Use key performance indicators to monitor performance of adoption and implementation of the eTMF process. Create new and/or revise existing strategies to ensure 100% compliance for all studies, whether they are in scope for the eTMF system or not
Serve as an expert point of contact for TMF, both internally and externally, and in doing so be effective in influencing and engaging across multiple lines and regions
Drive TMF strategies with external collaborators such as Transcelerate and others in the document management arena

Senior Director, Clinical Services Resume Examples & Samples

Implements corporate and clinical services policies and procedures at the center level
Maintains current knowledge of federal and state regulations and standards of accrediting organizations (AAAHC and Joint Commission) pertaining to ambulatory surgery centers. Supports assigned ASC’s in maintaining survey readiness
Monitors, audits and evaluates compliance with federal and State regulations, and the quality of the clinical services provided at assigned ASCs by conducting on-site assessments and developing and monitoring action plans to address areas for improvement
Responsible for all clinical aspects of assigned ASC’s performance
Addresses physician partner concerns and problems related to clinical services. Actively work to maintain and improve relationships with physician partners
Supports implementation of Quality initiatives
Monitors quality data and patient satisfaction data for each of assigned centers to identify areas for improvement and assist in development of improvement strategies
Supports implementation of CMS Quality reporting
Understands the partners, the practice and the market in sufficient depth to bring value to partners by participating in the centers’ business planning processes as it relates to Clinical Services
Communicates often, meets in person outside Board meetings, query satisfaction levels and work closely with all partners (not just board members) exchanging ideas and planning for the future
Educate partners regarding regulatory and accreditation standards to support continual survey readiness
Be viewed by the partners as a business asset and resource (not only for the ASC but practice and other ventures)
Supports analysis of supply, drug, and variable expense cost
Assists in preparation of Quality report for Center Board meetings
Supports educational needs of Center Leader and clinical staff
Actively participates in company-wide educational efforts, including Leadership Conference, new Center Leader training, and webinars
Participates in development and deployment of Best Practices
Maintains ongoing communication with assigned Operations lead VP regarding clinical, quality and risk management activities, corporate initiatives, trends, problems, issues, surveys, letters of deficiency and plans of correction, and sentinel events
Submit Weekly Report to Operations lead VP and VP Clinical Services
Maintains professional knowledge base and applicable certifications

Director Clinical Quality Resume Examples & Samples

Manages daily operations of the Quality department and all Quality related programs and assigned staff, providing oversight and guidance in delivery of process improvement initiatives and goals
Motivates and leads all assigned Quality related departments in setting and reaching departmental goals. Creates an environment where improvement ideas, team-building and creative thinking are encouraged to meet the organization’s needs for process improvement
Responsible for clinical quality measurement, providing analysis and reporting of quality measures to Executive Management Team within ABQ HP, parent organizations and to contracted entities such as health plans, in accordance with contracts, regulations or internal standards as applicable
Responsible for understanding the structure of the clinical data warehouse, providing oversight to decision support and IT teams responsible for creating these reports and ensuring the capture and analysis of relevant criteria. This includes identifying any data gaps and strengths, and deconstructing report data into the specific actions that can be taken by providers and staff to improve outcomes in the areas being measured, especially in relation to national, quality measurement criteria
Works as a cross-functional team member with physicians, peers and others throughout the organization to ensure the delivery of quality care and services. Participates and supports all organizational committees that are responsible for Risk Management, Quality, eHR decision support, Quality of Care and Peer Review, ensuring identification of quality improvement opportunities and the implementation of improvement activities
Works in collaboration with Clinical Management in grievance investigations and resolutions, quality initiatives and Peer Review activities, quality studies, credentialing, central Quality database and other related activities
Performs internal and external clinical quality reporting to provide Clinicians with transparent, actionable data with which to comply. Reviews and evaluates NCQA, (National Center on Quality Assurance), CMS, (Center for Medicaid/Medicare Services), Managed Care department and any other regulatory quality improvement requirements to ensure ABQ HP meets these standards
Reviews, revises and amends the Quality Program at least annually as applicable
Identifies, develops and oversees the educational needs of all Quality Department staff, providers and others in the area of quality improvement
Preferred: Over 10 years of management experience
Working knowledge of Microsoft applications (Word, Excel, PowerPoint)

Director, Clinical Affairs Resume Examples & Samples

Provide direct oversight to PPS’s & PCA's outpatient clinics. This includes financial accountability, cost containment and growth
OSHA Compliance Officer
HIPPA privacy and compliance officer duties and update office staff of changes and process paperwork in emergency cases
Ensure that PPS is compliant with Monarch and health plan contract provisions as they apply to clinical services (e.g., access, follow-up, etc.)
Ensure PPS is compliant with Risk Management issues as it relates to physician medical record documentation. Arrange for chart audits and physician in-services with PPS’s malpractice carrier
Responsible for hiring, layoff, and termination of clinic staff. Ensure that all clinics are adequately and appropriately staffed to handle workloads. Make recommendations for promotion and staff development
Planning, strategizing and implementing of new practice ideas. Assist VP of Operations in opening new outpatient centers bringing them online seamlessly and on budget
Responsible for completing clinical & administrative staff evaluations, as well as providing input into physician and mid-level evaluations. Provide recognition & acknowledgment when warranted
Oversight and review of service, incoming referrals and scheduling and appropriateness of referrals for capitated patients
Conduct clinic staff meetings on a monthly basis at each clinic. Conduct coordinators meeting on a monthly basis to enhance communication, share ideas, discuss billing and compliance with PPS P&P’s
Participate in educational events for PPS physicians and staff (e.g., Medtronic, CHF lectures, lipid lectures), that are appropriate for the services we provide
Interact with the Billing department to ensure coding compliance, e.g., timely submission, risk adjusted coding, etc
Ensure that the staff receives adequate training and support necessary to perform their duties and that they are current with accepted best practices
Interact with administrative and clinical staff at Monarch and various managers at Physicians’ groups to be proactive with PPS’s line of communication to ensure we are meeting client and patient needs. Resolve and troubleshoot any complaints
Responsible for physician service audits, mid-levels, techs, and office staff. Conduct monthly audits of nursing and clinic staff to ensure regular checks are performed on crash carts
Responsible for managing, trouble-shooting and resolving complaints in a collegial manner with physicians, medical directors, the PPS president and vice-president and staff as necessary. Handle all complaints that require telephone calls, letters, reviewing records, involving SCPIE and outside parties. Interact with administrative personnel at all hospitals and address any complaints from same
Support, promote and co-manage clinical research efforts with PPS Clinical Research Coordinator
Prescreen, tour and follow-up on potential candidates for physician cardiology positions with PPS
Responsible for updating and when necessary composing Clinical Guidelines for outpatient cardiology services and guidelines for office staff as necessary
Act as PPS liaison in the accreditation process for Nuclear Cardiology and Echocardiography and ensure compliance
Responsible for creating and monitoring the day schedule matrix for physician and mid-level coverage for both the hospitals and outpatient centers
Provide oversight and management to PPS Anti-Coagulation clinic. Work with Anti-Coagulation Manager to ensure patient and reporting compliance, manage resources and attend monthly utilization meetings at Monarch
Assist Vice President of Operations in providing oversight of centralized scheduling and manage day to day physician scheduling problems (inpatient and outpatient)
Responsible for compiling information regarding PPS’s outpatient center stats such as consults, post hospital appointments, and non-invasive testing, etc. (monthly access reports)
Oversee management of I/I scheduler and unit clerk
Ensure maintenance and service contracts are current and appropriate for company needs
Ensure patient and referring physician satisfaction and create and conduct surveys as appropriate
To act as PPS liaison with associated IPAs, health plans, hospital partners, physician groups and other related sources
In conjunctions with senior management. Write proposals when appropriate and promote PPS services to referring physicians
Responsible for financial accountability, cost containment and growth, and manage clinical operations within budget constraints. Develop annual budget and manage to budget
Responsible for sending out PPS communications to strategic partners and/or patient population when appropriate, and when suitable
15+ years’ experience
5+ years’ clinical affairs experience
Demonstrated experience managing one or more departments
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact

100

Director, Clinical Trail Management Resume Examples & Samples

Ensures operations team, locally and/or globally as appropriate, follow any and all SOP’s, policies and regulatory requirements. Also works in tandem with other Program Operations Leads to ensure consistent processes are collectively agreed upon and followed by all Global Clinical Trial Management team members. Ensures timely communication and problem resolution occurs when study progress may not be meeting study goals. Ensures documentation and reporting occur in a timely manner. Ensures appropriate global tracking and management of study is occurring. Provides operations services to Clinical Leads and Project Team Leaders. Operationally leads clinical research teams to rapidly deliver operational excellence for new projects or indications that meet minimum and desired characteristics for worldwide registration. Ensures all regulatory requirements are adhered to when applicable. Proactively plans study prioritization, budgetary requirements and goal attainment. Ensures consistency with processes and procedures
Provides timely feedback, coaching and counseling in partnership with Human Resources to ensure staff is performing their responsibilities at the most optimal level. Promptly deals with performance issues to minimize disruptions. Provides timely communication to staff members on all relevant matters, provides leadership to minimize distractions and disruptions. Ensures all performance evaluations are conducted in a timely manner. Collaboratively allocates resources based upon employee development needs, study staffing needs and other business requirements
Assists in the development of operations budgets ensuring program needs are identified in budget. Ensures study budgets are managed without overages or discrepancies
The role is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work
Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Other activities, special projects and assignments may be given as required

101

Director, Clinical Information Systems Resume Examples & Samples

Board Certified or Board Eligible Internal Medicine or Family Medicine physician
Board Certified in Clinical Informatics is recommended
Two (2) years of medical and clinical information system implementation experience (EMR/EHR, CPOE, electronic prescribing, health information exchange, etc.). Working experience with departmental applications (e.g. pharmacy, laboratory, radiology), and key information technologies underlying clinical information systems (e.g. relational database systems, integration technologies such as HL7, XML, and CDA). Understanding of medical vocabularies (e.g. SNOMED, ICD-10, LOINC, UMLS), enterprise master patient index, ARDEN syntax, biomedical device gateways, data warehousing, business intelligence tools

102

Director Clinical Information Systems Resume Examples & Samples

Works collaboratively to design, implement and maintain clinical applications
Minimum of three (3) years post graduate training, including five (5) years of Medicine and clinical Information system implementation (EHR/EMR, CPOE) experience
Ancillary Informatics experience a big plus
Knowledge of medical vocabularies (i.e. SNOMED, ICD9, LOINC, UMLS, Enterprise Master Patient Index, ARDEN syntax, Biomedical Device Gateways, Data Warehousing, and Business Intelligence tools, required
Strong leadership and interpersonal skills. Ability to deal with clinicians and administrators

103

Director, Clinical Management Resume Examples & Samples

Develops and maintains a working knowledge of all available services and resources available within the Company and the community
Directs staff to meet patient/client needs through the identification and use of all available resources
Ensures the program is in substantial compliance with all applicable licensure, accreditation and certification standards
Maintains the highest standards of professional conduct in relation to information that is confidential in nature. Shares information only when recipient's right to access is clearly established and sharing of such information is in the best interest of the patient
Adheres to and participates in Company’s mandatory HIPAA privacy program/practices and Business Ethics and Compliance programs/practices
Accompanies others on sales calls to provide clinical expertise, as needed
Performs all duties inherent in a managerial role
Directs and participates in clinical training programs for professional and paraprofessional staff
Provides education to the community of professional, paraprofessionals and other community members, regarding Applied Behavior Intervention (ABI) and Rehabilitation
Coordinates research reviews focused on evidence based practice, identifying reliable and valid treatment approaches
Represents company at National Conferences as needed

104

Assistant Director, Clinical Documentation Resume Examples & Samples

Strategic oversight of Clinical Documentation Center resources within assigned TA(s) to ensure successful study execution related to clinical documentation requirements
Provides tactical direction and oversight to CDC and broader organization to ensure real-time inspection readiness of clinical documentation
Analyzes metrics/ recommendations, makes decision on appropriate action and ensures action is taken in a timely manner; may collaborate with CDC Operations to identify areas for improvement
Works collaboratively across functional areas to lead initiatives related to clinical documentation
Fosters and maintains a culture inclusive of process improvement, collaboration and development
Reports to a Director and will have both direct and indirect reports
Operates within CDC approved budget

105

Director, Clinical Affairs Resume Examples & Samples

Support product efficacy and safety, facilitating commercialization of novel compounds, formulations, and tools, both for final products and for proof of principal studies
Develop compelling, creative, innovative, and differentiated clinical and consumer product claims and testing protocols
Develop and implement product testing processes based on type of launch, including, but not limited to, internal user testing, external user testing, sensory testing, clinical testing, and ingredient claims substantiation, all with specific testing objectives and action standards developed and agreed upon before study initiation
Develop internal skin physiology lab, including instrumentation, test panel, protocols and processes for rapid screening of formulations and POP studies
Elevate the rigor, processes, deliverables and expertise of the function. Identify gaps and develop processes and infrastructure to mitigate gaps
Interpret and integrate research data, draw conclusions/implications and translate into product development and claims recommendations
Audit/qualify external CROs and develop strategic partnerships. Develop clinical protocols, develop questionnaires, manage timelines, statistically analyze and present findings
Work with Market Research and Marketing on concept testing, home use tests and other consumer validation studies. Offer opportunities to improve consumer closeness and build learnings into product design
Ensure that testing activities and endpoints are properly aligned with corporate objectives
Develop effective and collaborative working relationships environment amongst internal/external team members and vendors
Develop and implement product testing in new markets to support global launch initiatives and understand future markets
Develop standard safety testing protocols that align with corporate objectives (i.e. non-acnegenicity, non-comedogenicity, cumulative Irritation)
Infrastructure development
Demonstrated advanced knowledge of design and all phases of clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices
Excellent attention to detail and accuracy in work, ability to handle multiple tasks, strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
Understanding, identification, mitigation, and communication of risks at the study or program level
Proven experience working in a global, matrix organization on a global/international clinical development program
Excellent sense of urgency to deliver at/surpass study conduct targets
Strong leadership skills, self-motivated, adaptable to a dynamic environment, interpersonal, organizational and supervisory skills
BA/BS or equivalent degree in scientific discipline. Advance degree preferred
10+ years of clinical research experience in the skincare industry
Minimum 5 years of experience in a management/supervisory role
Previous experience with development of SOPs, work instructions, and procedures
Able to credibly represent the company in any potential claims challenges
Demonstrated financial acumen in planning and managing clinical program budgets
Proven ability to successfully plan, implement, and manage multiple clinical programs/studies
Experience at/or oversight of outside clinical research vendors (CROs, central laboratories, imaging vendors, etc.)
Knowledge and understanding of statistical analysis as applied to clinical and consumer data
High degree of proficiency in all Microsoft Office platforms including data manipulation and graphing in Excel, Powerpoint, and other organization tools

106

Program Director, Clinical Program Resume Examples & Samples

Patient Satisfaction/Patient Care Coordination Needs Met
Business Development
Meet Regulatory Standards
High Quality Patient Care
Employees Highly Skilled and Satisfied
Health Care Team Satisfaction
Financial Goals Achieved
Minimum two (2) years of experience in pediatric cardiovascular nursing
Experience in regional/tertiary cardiac center preferred
Prior management or program coordination experience
Experience in staff education/professional development preferred
Demonstrates good presentation and writing skills
Able to write strategic business plans
Able to complete SWOT analysis
Above average skills in Microsoft Word, PowerPoint and Excel
Excellent grammar and clarity in articulating in English

107

Director, Clinical Quality Resume Examples & Samples

Providing primary oversight for quality initiatives that meet contractual requirements
Serve as the lead in Compliance with CA State requirement for quality Improvement. including but not limited Facility Site Reviews
BS Nursing or Public Health or Business preferred. Advanced degree is preferred
8+ years experience in Quality Improvement within a health plan or managed care

108

Director, Clinical Engineering Resume Examples & Samples

Maintains a broad working knowledge in all healthcare regulations and understanding of health care regulations pertaining to the management of medical equipment. Continually improves knowledge of regulatory changes. Serves as a resource for all corporate / clinical / regional and corporate entities regarding compliance needs and regulation requirements for the management of medical equipment
Partners with operational / clinical / regional and corporate groups to conduct monitoring activities, implement corrective action plans and evaluate the effectiveness of the medical equipment management plan. Assesses various aspects of documentation as required by Federal, State, and other regulatory agencies for the management of medical equipment to ensure and enhance patient safety. Measures (survey, monitor, and report) compliance to Federal, State, and regulatory agencies
Develops, initiates, maintains, and revises policies and procedures for the general operation of the CTM Compliance Program and its related activities to prevent illegal, unethical, or improper conduct
Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations
Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends
Serves as a subject matter expert and resource to others and may act as an advisor for the compliance department, safety committees, risk, and the environment of care, specifically to be utilized in response to the management and use of medical equipment
Analyzes the results of internal and external compliance audits, equipment failure reports, equipment service reports, and all other Clinical Engineering Data, and utilizes this information to focus on potential education and implementation of corrective action plans to improve overall processes and documentation accuracy throughout the system
Conducts training sessions and audits of Clinical Engineering operational areas to assess and improve understanding of compliance, risk, quality, and regulatory requirements for the management of medical equipment

109

Director Clinical Excellence Resume Examples & Samples

Coordinates and facilitates Shared Governance and Nursing Retention programs, strategies and initiatives, including materials and resources as needed to ensure goals and objectives for quality patient care are achieved
Works with Shared Governance councils and unit based councils to enhance the Shared Governance infrastructure, and ensure strong channels of communication across all partners of the enterprise
Works closely with department leadership, administrators and health care professionals in areas related to the Shared Governance process
Develops and creates presentation materials including relevant data
Participates in the presentation and publication of Shared Governance
Collaborates with academic/clinical nursing programs in onboarding of nursing and nursing support staff
Maintains organized documentation of Shared Governance activities and other clinical excellence projects and initiatives
Ensures that staff is informed regarding the Shared Governance process, goals and objectives

110

Director, Clinical Transformation Resume Examples & Samples

Successful track record of leading clinicians through practice change
Strong analytic/conceptual problem-solver, with ability to work in ambiguity and problem-solve with both senior executives and front-line clinicians
Strong lean or continuous improvement methodology skills
Ability to influence without formal authority
Ability to lead change in face of resistance

111

Director Clinical Quality Resume Examples & Samples

Perform management responsibilities to include, but are not limited to: involved in hiring and termination decisions, coaching and development, rewards and recognition, performance management and staff productivity
Plan, organize, staff, direct and control the day-to-day operations of the department; develops and implements policies and programs as necessary; may have budgetary responsibility and authority
Collaborate across the enterprise to identify programs that align with the mission to improve care and improve patient experience/outcomes while reducing the overall cost of care
Responsible for the implementation of safety and quality strategic initiatives with development of action plans that include clarifying the goals/aims and metrics, collaborating with team members to identify ideas/solutions, applying change methodologies, coordinating activities designed to reinforce and embed best-practice changes and next steps to create continuous improvement
Participate in and/or leads the various quality improvement or other teams in conjunction with clinical and commercial teams
Provide direction and supervises direct reports to ensure that efforts are consistent and complementary
Collaborate with commercial operations to develop specialized networks and programs with appropriate staffing, knowledge and facilities as appropriate through education and training
Develop quality metrics and education initiatives for pilots and strategies that improve and challenge our current delivery model and addresses challenges in hand-offs during transitions of care, safety and appropriate levels of care
Identify outcome measures that test efficacy of clinical programs that comply with industry accepted QI/UR measures and processes
Represent the organization on selected agency committees as requested
Master's Degree - Health Administration, Nursing Home Administration, Nursing or related
5 years of healthcare or related experience
1-2 years of supervisory experience
3 years of experience in the post-acute space
Understanding of various healthcare quality standards: STARS, HEDIS, CMS COMPARE
Understanding of data analytics
Computer proficiency in Microsoft Office
Experience working as part of a team
The ability to work in a complex institutional structure requiring significant collaboration and matrixed reporting
Expertise in operations, regulatory issues and clinical care best practices
Demonstrated ability to work well under pressure, within strict time parameters, and with a strong attention to detail
Ability to work independently with minimal supervision , strong planning and organizational skills

112

Senior Associate Director, Clinical Systems Resume Examples & Samples

Provides leadership and strategic direction to the Clinical Systems group
Accountable for architecting systems infrastructure underpinning all US ClinOps activities: entering and handling of relevant data to group-specific systems; KPI reporting; managing aggregate spend / Sunshine Act reporting; vetting of investigators, and entering and managing of IDBs (Investigative Database); overseeing required system audits; and leading the provision of training and technical support
Leverages deep technical expertise, knowledge of technology trends, and clinical trials experience to define vision for future evolution of ClinOps systems
Guides development and implementation Clinical Systems-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
Oversee third-party vendor(s) to address performance issue for in-sourced resources (Clinical System Programmers) and ensure deliverables are of high quality within planned timelines against contracted scope of work (SoW)
Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Clinical Systems group to deliver value and enhance overall operational effectiveness
Actively remains current with industry standards, trends, and competitive intelligence on Clinical Systems best practices
Leads and fosters a culture of close partnerships with Study Management & Conduct, Site Monitoring, Quality Management, Clinical Trial Supply Unit (CTSU) and Global Sourcing Departments, ClinOps Analytics group, Global Systems, COPI, and Cornerstone team to assure a closely coordinated program of activities based on common objectives and focusing on value, quality and operational efficiencies
Partners with Clinical Application Support (CAS) and local IT organization to ensure the needs of the Clinical Operations function are incorporated into the development of new systems and refinement of existing systems
Support Director in management of annual budget and quarterly forecasting for cost center. Monitor expenditure of budgeted funds, when possible build in cost efficiencies and provide justification of variances. Monitor and approve service provider and independent contractor invoices
Lead and/or represent Clinical Systems processes on local/global working groups
Ensures commitment to customer-centric behaviors: provides visibility to trial teams and broader Clinical Operations into ongoing work through up-to-date tracking; maintains high degree of responsiveness to both internal and external requests; resolve issues by working collaboratively across Clinical Operations and other groups within BI
Identifies, develops, and/or delivers appropriate training for the Clinical Systems group in partnership with the Training and Compliance group
Create a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge, process and procedures. Set job expectations, provide regular feedback, conduct timely MAG Plan reviews, identify performance challenges, oversee the creation and monitor the effectiveness of action plans

113

Director, Clinical Services Resume Examples & Samples

Oversees the statewide clinical operations for all clinical disciplines
Maintains effective clinical staff coverage for the practice within budgetary guidelines
Oversees the completion of performance evaluations including development of performance objectives and developmental goals each year. Assists in the development and preparation of short term and long range plans and budgets based on organization goals and objectives. Hires and coordinates training for all clinical personnel
Directs the correct use of charge codes and educates all clinical staff in correct documentation per reimbursement guidelines
Knowledgeable of applicable labor laws and schedules and coordinates employee vacations, sick leave and overtime
Provides staff training and in-services as required
Develops new services and activities of patients, families and staff in accordance with practice service objectives
Develops annual operating goals and budget for the clinical department in support of the practices business plan under the direction of the Executive Director and Controller. Controls the clinical departments operating costs within budget parameters

114

Director, Clinical Sciences Resume Examples & Samples

Defines clinical trial-related goals and objectives
4 – 8 years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials
Must be able to work productively in a fast-paced collaborative environment
Prior experience with mentoring and leading cross functional teams

115

Director Clinical Bioanalysis Resume Examples & Samples

Primary responsibility for choosing bioanalytical CRO, for providing specification and validation parameters appropriate to the investigational phase of assay methodology, including all documentation needed for study and regulatory write-up. Oversight of all assays so as to meet Daiichi-Sankyo project requirements for quality, time, and cost
Primary responsibility for delivery and certification of data from all assays to the clinical team that meets agreed to timelines
Working with study teams to ensure implementation of appropriate sample logistics, including meeting all appropriate labeling and legal requirements, and the choice, cost and oversight of carriers
Primary responsibility at the project team level for providing in a timely manner standardized sample collection, storage and transmission specifications for use in protocols to ensure the integrity of samples and validity of subsequent sample assay
Establish, maintain and improve standardized working processes to ensure uniform and cost effective practices in clinical bioanalysis
Providing active and knowledgeable support for novel assay samples and methodologies, especially in the early lead optimization and PoC phases
10+ years relevant industry experience (5+ years in clinical development), including CRO monitoring
Experience in addressing inquiries from regulatory agencies regarding specific issues on bioanalytical methodology and when needed, formulating strategies for regulatory interactions
Experience with assay development for antibody-drug-conjugate (ADC) programisms, as well as critical reagent development

116

Director, Clinical Chemistry Resume Examples & Samples

Monitors the AHN laboratory testing procedures, resolves problems, and provides direction
Serves as consultant to AHN medical staff in areas of expertise
Oversees technical management of clinical chemistry, immunology and point of care testing, oversees test development of AHN laboratory system
Instructs residents, fellows, and other health care professionals in clinical chemistry, immunology, and point of care testing
Provides administrative leadership as needed for all AHN laboratories, including Core Lab
Pursues research in chemistry, immunology, urinalysis, and point of care testing and represents the Department of Laboratory Medicine at AHN's laboratory by serving on committees
Provides leadership to staff to ensure quality patient care by utilizing the performance improvement model to correct quality issues. Ensures compliance standards are met according to governmental and accreditation standards

117

Associate Director Clinical Trials Resume Examples & Samples

Act responsible for operational oversight and execution of late phase and/or observational clinical trials within Medical Affairs from inception to completion
Ensure completion and quality of project documentation including project plans (i.e. resources plans, risks plans, and communication plans) through the life of the project
Anticipate and resolve challenges affecting delivery of goals and objectives and liaise with a cross-functional team to influence solutions
Effectively manage external vendors (i.e. Clinical Research Organization, Interactive Web Response System) to ensure study is successful delivered on expectations of quality, timelines and budget
Manage external consultations to ensure smooth and compliant implementation of REMS program(s) including the monitoring and verification of task delivery/completion
Lead the review and finalization of REMS documentation and provide status reports to management
Manage vendor budget and deliverable timelines
Collaborate with Legal, Compliance, Regulatory Affairs, PV and Medical to ensure compliance with REMS program and regulations
Lead execution of complex projects and programs in accord with Bayer’s governance processes
Maintain ongoing responsibility of updating databases including the global database (currently dbox) and master study database (currently IMPACT)
Collaborate with Legal, Compliance, Regulatory Affairs, GMA as appropriate and CRO(s) to establish appropriate study processes to ensure compliance with guidelines and regulations
Evaluate Study processes, contracts and documentation to ensure adherence to corporate Compliance and Legal guidelines and/or requirements
Collaborate directly with Legal, Compliance, Regulatory, and Drug Safety in order to address issues or further clarify policies
Act responsible for promoting adherence to the Bayer Healthcare Compliance Program including, but not limited to, the Bayer Healthcare Code of Conduct and applicable Policies, Procedures, and applicable SOPs, OIG regulations and PhRMA guidelines
Work closely with Therapeutic Area (TA) VP and Medical Experts/cross functional partners to ensure alignment across Medical Affairs priorities and successful implementation of cross BU initiatives
Bachelor’s Degree in Life Sciences with 6 or more years of experience in pharmaceutical industry
An in depth knowledge of the clinical trial management process including, monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, and budget and financial tracking
Proven project management skills, including effective planning and organization skills, attention to detail and excellent follow through
A high level of sensitivity in communication across different levels of hierarchy & across department boundaries (e.g. with Commercial, Global Development, Statistics, Procurement) and the ability to be able to influence & motivate for cooperation successfully without formal authority
Experience in late phase clinical trials
A thorough understanding of PhRMA and OIG guidelines as well as pharmaceutical industry experience in medical affairs, field medical affairs, scientific publications or key opinion leader activities
A thorough understanding of the forecasting and budgeting process, as well as knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
Advanced degree in a scientific field with at least 4 years of experience directly related to clinical research or medical affairs experience
Experience in management of Risk Evaluation Mitigation Strategy

118

Director, Clinical Services Resume Examples & Samples

Works within the Post-acute services framework by optimizing Long term care and Swing bed services as well as wound Care
Ensure that Long term care leadership teams participate in company-wide clinical professional development and clinical leader mentorship/development activities
Works in concert with the Post-Acute Operations Team members to create, foster and maintain a culture of safety and quality throughout all post-acute organizations
Develops and implement standardized clinical guidelines across the facilities
Effectively communicate with group leadership team members and facility staff leadership, regarding updates, identified issues or process improvement activities within the services
Provide guidance to facility leadership/staff on regulatory and compliance issues as identified or as industry changes occur
Possess excellent communication skills in mentoring leadership and staff members within the Post-acute service locations
Ensure, obtain and compile a monthly operational and quality report that consolidates all homecare and hospice findings and promotes early identification of negative trends and or best practices
Complete monthly operational reviews for all post-acute locations
Complete monthly or as needed conference calls to promote and develop a strong knowledgeable team
Act as the subject matter expert in long term care IT systems; provide education and onboarding to the field
Become the go-to person for long term care and swing bed quality across the organization
Assist with orientation and development of strong clinical leadership teams within the long term care service locations in order for successful succession plans to be implemented as necessary
Review outcome information and identify clinical operating indicators on an ongoing basis for potential issues or trends and implement interventions or corrective action plans as indicated
Collects, compiles, analyzes and interprets performance improvement data and presents to the facility leadership teams as required
Ensure that PAC leaders and managers remain current on accreditation standards and regulatory requirements
Conduct pre-survey assessments PAC survey readiness approximately 3 months prior to each facility’s anticipated survey
Prepare and present educational programs using adult learning principles
Coordinate and/or conduct workshops or conferences as indicated for PAC facilities on topics relating to accreditation issues, resource management, case management, finanicial optimization, clinical documentation, clinical professional development and clinical leadership development, patient safety, or other relevant clinical topics
Act as a liaison with other departments and outside resources to insure delivery of safe, effective quality care
Provide operational evaluation, development, and implementation and variance determination though on site and data metrics review monthly

119

Director, Clinical Documentation Excellence Resume Examples & Samples

Change Leadership: Supports the structure, organization and culture for continuous quality and operations improvement. Initiates and facilitates redesign and Clinical Documentation Improvement strategies for strategically important priorities within the organization. Creates detailed, comprehensive project and action plans and timelines to ensure successful execution of programs. Monitors and measures results; develops standards and applies benchmarking and best practice applications to support improvement at the team and organizational levels. Acts as a consultant and advisor to leadership to build consensus and support for CDI initiatives at an organizational level. Researches and remains current on CDI opportunities, and methodologies appropriate for a healthcare environment. Provides training and education to support CDI initiatives in the organization. Consults with organizational learning and development and designs educational curriculums and programs to support leadership, medical staff and employee education and training to participate in CDI initiatives. Mentors and supports local CDI Managers and staff and other organizational leaders and change efforts to support their development and improvement efforts. Assists leaders and teams to facilitate major change and organization improvement
Metrics and Reporting Leadership
Bachelor's Degree in Nursing, Health Care Administration, Business, or related field preferred, OR equivalent combination of education and work experience
Certification / Licensure / Registration
Lean or TPS required within 1 year of hire
Six Sigma Black Belt Certification preferred
4-6 years’ Experience in leadership and/or management required
4-6 years’ Experience facilitating CDI teams/role as a change agent required
4-6 years’ Experience in teaching and instruction required
4-6 years’ Hands-on experience with CDI methodologies and approaches required
Strong Verbal Communications Skills,
Strong Written Communications Skills,
Excellent Interpersonal Skills,
Computer skills: Access, Excel, PowerPoint, MS Word - Intermediate Level,
Excellent Organizational Skills,
Ability to lead, coach and persuade others as needed to accomplish projects,
Knowledge and experience with rapid cycle performance improvement,
Ability to work with statistical concepts and analysis,
Knowledge of organization and leadership development concepts and tools
Work is performed in a standard office environment

120

Director Clinical Systems Resume Examples & Samples

Implemented electronic health records and computerized physician order entry
Acute Care or Emergency Department Nursing Background
Subject Matter Expert in clinical workflows and clinical informatics best practices
Lead large-scale hospital partner and THP projects and cross functional teams with medium to high complexity
Build and test of clinical information systems and elbow to elbow in person and web based go live support
Participate in the formulation of annual budget and goal reviews for the information technology department
Perform RFP and analysis of new or replacement systems and technologies
Project Management of milestones, deliverables, testing, training, resources, issues, risks, and lessons learned
Responsible for building consensus, change agent, and promote adoption of best practices and innovations among stakeholders
Design and build dashboards, analytics, and reports for clinical, operations, and quality departments
Experienced developing and presenting training programs to clinical staff including nurses, physicians, and hospital administration
Recruit, manage, hire, mentor, knowledge sharing of team of clinical systems managers, analysts, interns
Ensure HIPAA compliance, safeguards, privacy and security of protected health information
Upholds the values and mission of the Tandem Hospital Partners family
Understands clinical systems, answers technical questions and performs all assigned tasks
Use tools provided to develop and maintain applications, reports and other solutions
Translates customer requests into software application solution specifications, appropriate to assigned tasks
Maintains detailed technical knowledge of assigned systems
Work with internal clinical, operational and revenue cycle teams on workflows, build, testing and training
Work with hospital partner clinical teams on workflows, build, testing and training
Identifies issues and concerns and communicates them to the leadership team. Develops options and recommendations
Assists customers with optimizing their use of assigned systems and specific project-driven tasks. Participates in application support as needed
Other – Performs other duties and special projects as assigned by VP of IT or Chief Technology Officer
Adhere to all THP policies, procedures, and standards, within budgetary specifications, including time management, supply management, productivity, and accuracy of practice. Promotes individual professional growth and development by meeting requirements for mandatory/continuing education, skills competency, supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor, and resource to less experienced staff
Bachelor’s degree or equivalent, required
Master’s Degree in Healthcare or Business Administration, preferred
Eight (8) years of increasingly responsible experience in a large, corporate systems development and implementation activities in a wide variety of Healthcare Management Information Systems (MIS)
Training experience in clinical systems, workflows preferred
Licenses/Certifications: Licensed or credentialed in a clinical discipline
Basic working knowledge of application support, development tools and methodologies
Hospital Management Leadership Experience, preferred
Experience in Epic, Cerner, Allscripts, or Meditech, preferred
Passion for innovation
Excellent understanding of the organizations goals and objectives
Highly self-motivated and directed, with keen attention to detail
Able to prioritize simultaneous projects and execute tasks in a high-pressure, short timeline environment
Knowledge and ability of needs, goals, deliverables and interdependencies of other functional departments
Able to keep a positive attitude and problem solving stance in difficult circumstances
Highly resourceful team-player, with the ability to be extremely effective independently

121

Assistant Director, Clinical Practice Plan Resume Examples & Samples

Bachelor’s Degree in Business Administration, Finance or related field, required. Master’s Degree, preferred
Minimum of five (5) years progressively responsible experience managing faculty practice plan operations, primarily in front office
Knowledge of Federal, State and third party payor reimbursement rules and regulations, ICD-9-CM and CPT-4-codeing practices
CPC, highly desired
Revenue cycle experience in a hospital or multi-site practice setting, highly desired

122

Director, Clinical Services Resume Examples & Samples

A Master’s degree in Hospital and Health Administration, Public Health or Business Administration or equivalent combination of education and experience is required
Comprehensive (5-7) years of progressive healthcare leadership/administrative experience preferably in an academic medical center
Expertise in financial management, practice management, and human resources required
Experience with budget preparation and implementation
Strong strategic planning skills
Demonstrated job-related experience with and/or commitment to diversity in the work/academic environment
Excellence written and verbal communication skills
Demonstrated ability to drive organizational change
Previous experience in academic/medical administration and expertise in physician compensation and reimbursement, grants management and revenue cycle management are desirable
Previous experience in the administration and management of primary care clinical settings is preferred
Demonstrated results in improving patient satisfaction levels
Demonstrated results in improving access and clinical operations
Experience managing in a unionized environment
Membership in the Medical Group Management Association or American College of Healthcare Executives

123

Director Clinical Quality Resume Examples & Samples

Provides expert knowledge for the wide range of exploratory research activities (collaborations/ acquisitions, non/low intervention studies) in order to ensure compliance regulatory requirements and overlap/interdependence with the GCP areas for the fast changing research environment. Lead/support evaluation of existing clinical processes across NIBR for the identification of risks and potential gaps to Novartis and regulatory requirements. Work effectively in a matrix environment with stakeholders to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance
Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter, supporting business partners and assist with achieving deliverables per set targets
Collaborate with internal partners and other Novartis functions to drive Quality

124

Director, Clinical Quality Programs Resume Examples & Samples

Creates and supports an environment where improvement ideas, team-building and creative thinking are encouraged to meet the organization’s needs for process improvement
Reviews and evaluates NCQA, DMHC, CMS, Medicaid, and any other regulatory quality improvement requirements to ensure DHCP meets these standards
Reviews, revises and amends the Quality Improvement Program and Work Plan at least annually as applicable
Works with the Senior Director of Quality in the creation of reports and analysis of data that will meet the needs of the regions and the Office of the Medical Director (OMD)
Provides supervision and guidance to the Central and Regional Quality Teams with grievance investigations and resolutions, QI and Peer Review Committees, QI studies, credentialing, central QI database and other related activities
Participates in and supports organizational committees such as the OMD, Medical Committee, Regional Quality and Peer Review
Accountable for organizing and facilitating the quarterly Quality and Language Assistance meetings including maintaining a management process for the gathering of reports and the integration into a cohesive presentation
Works in collaboration with the OMD, Care Management, Risk Management, Regional QI and Peer Review Committees and other departments to identify opportunities for quality improvement and implementation of improvement activities
Submits a semiannual quality improvement report to health plans and any other requests as applicable
Ability to interact with cross functional departments including operations, IT, and the medical management team
Reviews Language Assistance DMHC regulations and updates the Language Assistance Program as needed
Ensures that health plan corrective action plans are submitted timely
Identifies, develops and oversees the educational needs of the QI staff, providers and others in the area of quality improvement
Key participant in health plan and DMHC quality oversight audits
Motivates and leads the QI department in setting and reaching departmental goals
Develops and manages an annual departmental budget and goals
Ability to make judgments regarding medical care

125

Director, Clinical Trials Management Resume Examples & Samples

Lead clinical studies teams and deliver clinical studies/programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and all applicable regulations and requirements and manage all clinical operations activities for CSS franchise globally to insure appropriate resources, timelines and budget are in place for regional sites/activities
Collaborate with Clinical R&D Franchise Leaders to identify and ensure global strategies, resources and accountabilities are in place to achieve rapid, cost-effective and well-executed clinical studies, for the supported franchise delivering high quality clinical data to support Regulatory, Market Access and reimbursement needs
Provide internal communication to key stakeholders of important clinical data and events (inc. escalation of compliance issues and status reports) and project updates
Develop innovative solutions for complex problems, risk management strategies, and resource allocation
Communicates with and supports management of vendors (CRO, Central lab, etc.), as needed
Ensure Regulatory body inspection (including BIMO) preparation and readiness (including study documentation filing and maintenance appropriately and timely)
Participate in evidence generation reviews, Protocol reviews and project core teams as needed and appropriate
Support Clinical Operations and Clinical R&D Franchise by taking on other tasks, as needed
Exhibit proficiency and acts as a Subject Matter Expert in clinical trials involving complex execution issues
May serve as a J&J representative on Industry committees/organization
Bachelor’s Degree with 12 years of relevant experience OR a Master’s with 10 years’ Experience OR a PhD/MD/PharmD with 8 years of relevant experience is required
Investigational New Drug/Device Exemption (IND/IDE) experience is strongly preferred
Experience in Cardiovascular and/or Neurovascular/stroke studies is strongly preferred
A minimum of 3 years supervisory experience is required
Proven track record in project management of clinical studies is required
Clinical Research Organization (CRO) management experience is strongly preferred.0695170510

126

Director Clinical Quality Resume Examples & Samples

Serve as primary liaison with UHC Community National Quality Team, effectively leveraging and coordinating national quality team resources and initiatives with local health plan quality resources, initiatives and requirements
Responsible for NCQA readiness, accreditation, and ongoing compliance with NCQA requirements
Providing effective leadership and management oversight of direct reports and members of the quality team
Developing and implementing programs and processes to achieve HEDIS and state value-based purchasing program requirements
Establishing and implementing initiatives to achieve maximum results from CAHPS and state provider satisfaction survey initiatives
Establishing and implementing governance and oversight of health plan quality program, including coordination of committee structure described in the health plan quality improvement program
Serve as primary driver of Performance Improvement within the health plan, including committee oversight, work plans and annual evaluation
Serve as the lead in establishing and implementing Health Education Program
BS, Nursing, Public Health or Business preferred; Advanced degree is preferred
5+ years of experience implementing effective HEDIS programs and NCQA accreditation
Experience managing and coordinating regulatory audits including documentation, onsite preparation, and responsive corrective action plans
4+ years demonstrated previous management experience
Prior experience and familiarity with audit processes of External Quality Review Organizations (EQRO)
Previous experience working as an executive-level health plan quality leader strongly preferred

127

Director, Clinical Resume Examples & Samples

Clinically advise the Marketing and Commercial teams on troubleshooting Invisalign cases, building confidence in penetration and adoption of the Invisalign aligner system and iTero scanner
Build a network of KOLs in each market and at APAC level to promote Invisalign system adoption, penetration and utilization
Develop and drive local, region and global publication strategy and execution to promote the Invisalign product and iTero scanner
Clinically advise the Marketing and Commercial teams future changes to the Invisalign product leveraging global knowledge on clinically uses of our existing product
Clinical advise the global marketing and international marketing team on claims and proof of efficacy
Key member of the global clinical team with responsibility to share future recommended changes to the Invisalign product and clinical competitive intelligence
Serve as the clinical leader on all aspects of the physical product and competitive intelligence
Core member of projects for treatment planning, clinical support model projects or any other projects that require product or clinical input
Work with APAC Clinical and Marketing teams to establish and execute training programs and partnership with Universities. Work with teams to ensure adherence to key messaging and updated clinical information. Approve and review content for GATI
Develop advisory boards in the region and markets. Oversee development of content of clinical training and reference materials. Work with teams to ensure adherence to key messaging and updated clinical information. Approve and review content for GATI
Serve as clinical business partner for country and APAC summits, develop main content and speaker management
Own and manage personnel for International Gallery Program including yearly Smilescore program. International list of publications and library
Responsible for Clinical Support Messaging & Protocols. Manage content, process, and message of clinical support team with quarterly meetings as well as International team meeting. Work with Costa Rica and APAC Treat centers on protocols for product and technicians. Establish and provide clinical training to internal employees
Serve as clinical business partner for International Product launches, which includes messaging creation, clinical protocol creation and clinical input
Maintain up to date information on R&D, publications, academia, thought leaders and education, through the appropriate leads, ensuring consistency and provide feedback to global and R&D
Collaborate with Global Clinical Study and R&D teams including partnering with the clinical technology team on studies for APAC such as writing of hypothesis and study protocols as well as Study doctors for recruitments, consents, monitoring, etc
Manage clear aligner research award program as well as limited releases and pilot programs. Manager multiple countries and multiple different legal and regulatory requirements
Support marketing/legal/and other functions on collateral reviews
DDS degree or equivalent; Certificate of Orthodontics from an accredited University or Post Graduate education in Business would be an advantage
Seasoned regional leader with a successful track record of at least 15 years clinical and commercial management experience
Experience working in a global matrix organization and successful partnership in collaborating with cross functional teams, regional groups and local markets is preferred
Demonstrated track record of people development and leadership
Experience in providing thought leadership - taking business / customer insights and using them to drive thinking and decisions
This role requires 50% regional travel
Strong interpersonal skills and ability to interact effectively with key opinion leaders, health authority and internal and external stakeholders are required
Experience in developing and managing strategic relationships with clinical experts/KOLs is required
Strong influencing and communication skills, a collaborative approach and strategic business acumen
A demonstrated track record leading matrixed, cross-functional work teams
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues
Ability to think critically and scientifically
Ability to write scientific protocols and scientific articles
Spoken languages: English – Required. Mandarin, Japanese, Korean - Plus

128

Director Clinical ICU Resume Examples & Samples

Demonstrates commitment to the universal guiding principles of the patient care model in order to achieve the HealthEast Nursing Vision
Creates unit/service line plans and set goals based upon the HealthEast mission, core behaviors, and clinical and organizational strategies
Creates a professional climate, which utilizes teaming and effective communication to meet the identified goals
Responsible for the leadership and management of the unit human resources to ensure a culture of high employee engagement with qualified, well trained employees who have a focus on clinical outcomes and customer satisfaction
Manage fiscal resources creatively and efficiently to achieve productivity and expense benchmarks
Collaborates with the Advanced Practice Nurse, Clinical Manager, and unit staff to drive the Unit Quality Improvement Processes
Achieves customer service excellence by understanding the needs of all internal and external customers (patients, families and physicians)
Ensures compliance with regulatory requirements, patient safety requirements, established practice standards, policies and procedures
Bachelor's degree from an accredited School of Nursing required
Masters degree in nursing or related field preferred. Must be enrolled in a Master's program within 18 months of hire
RN-MN License required thru MN Board of Nursing
4 to 6 years of nursing experience
2 to 3 years of progressive leadership experience (i.e. charge nurse, preceptor, project/committee management) preferred
Operational management experience preferred
Connecting People to Purpose: Bringing the vision to life
Engaging the Team: Fostering a climate in which people want to do their best
Interpersonal Savvy: Building relationships through effective communication
Systems Thinking: Understanding how things influence one another other within a whole; carefully balances the good of the department or site with the entire organization
Knowledge: Knowledge of staffing and scheduling processes and tools

129

Director, Clinical Services Resume Examples & Samples

Create and communicate a vision of success for Gateway's Clinical Services department, delineating measurable goals that are consistent with, and contribute to, achievement of high level of quality, service, and outcomes
Provide effective leadership, strategic direction and business planning for Gateway's Clinical Services department, including Utilization Management, Disease Management and Case Management activities, to measure and improve quality of health care provided to members
In conjunction with medical staff, plan, implement, direct, evaluate and continuously improve the organization’s use of Medical Management
Assure periodic review of internal and external benchmark data, quality management data, and risk management data for the purpose of prioritizing clinical improvement initiates
Establish operational as well as outcome monitoring systems related to clinical improvement initiatives
Stay current with industry best practices to develop strategic and operating plans. Develops and ensures execution of these plans
Directs UM, CM and DM operations to ensure medically necessary services are provided in a timely, cost effective and quality manner and at the appropriate level of care
Analyzes and reviews utilization and health cost data to identify opportunities of clinical quality improvement, cost savings and support of revenue maximizations
Participate in the planning, development, and implementation of major policy and business initiatives. Assists in review and approve contracts and legal documents related to clinical services and clinical performance
Tracks laws and regulations applicable to Program and ensures compliance with all applicable laws, rules, regulations and contractual requirements
Establishes processes for initial and continuing staff training and competency verification of personnel. Evaluates staff educational needs and coordinate training
Maintains fiscal responsibility for departmental operations. Directs the development, implementation, and evaluation of department budget. Integrates financial information for use in clinical resource management
Establishes and communicates department goals and accomplishments, incorporation of individual and team efforts in formal and informal feedback and recognition programs
Creates an atmosphere of collaboration, building effective partnerships within the department and organization. Interact with providers, vendors, Members, regulators and other outside organizations/persons in a manner that assures a positive customer experience
Representative and Liaison to external stakeholders, including local, State, Federal/National regulatory entities
Bachelor’s Degree in Nursing or public health field
Five (5) years’ experience with continuous quality improvement processes including project planning and managing multiple priorities
Five (5) years of experience interpreting regulations and assessing plan impact, implementing processes to enhance compliance, and auditing results
Five (5) of leadership experience
Current RN license for state of Pennsylvania
Strong analytic skills and a broad working knowledge of current health insurance accreditation guidelines and applicable government regulations
Master’s Degree in Business Administration or health-related field is preferred
At least three years’ experience working in an outpatient clinical setting

130

Director, Clinical IS Operations Resume Examples & Samples

Root cause analysis following high impact changes
New technology evaluation which could improve Operations or Optimize Costs
Ability to be a strong leader and communicate at a high level to project sponsors, executives and hospital leadership
Mentor and grow leaders within the organization while promoting HRO principles
Create and advise on vendor risk assessments for infrastructure upgrades
Minimum 5 years of leadership experience with healthcare information systems and technology
Minimum 4 years with a EMR system (Cerner, NextGen, Meditech and McKesson preferred) including broad exposure to entire product suite
Structured ITIL processes
Worked in an environment encompassing 3-tier architecture including Citrix, Oracle, and Unix systems
Previously worked with a large EMR system
Strong customer service, coordination and interpersonal skills
Diligent, detail oriented and structured with the ability to remain impartial
Proven experience in effectively grooming new leaders
Planning, organizing, and facilitating remediation activities
Reporting, monitoring, and resolution of process and system related issues

131

Director Clinical Services Resume Examples & Samples

Three years of relevant administrative leadership
Five years of clinical experience in the behavioral health services, with a focus toward youth and family
Can function independently and /or collaboratively as a team member and leader
Possesses effective team building skills
Business/administrative skills sufficient to effectively manage the assigned business units
Ability to cognitively analyze & reason to perform above responsibilities
Auditory or visual skills to perform above responsibilities
Excellent interpersonal relationship skills
Possesses strong communication (written and verbal) skills
Computer and data analysis skills sufficient to monitor and ensure staff compliance with the clinical and operational requirements of the assigned business units

132

Director, Clinical Services Resume Examples & Samples

Utilize a full range of leadership and management skills; develop and achieve departmental goals and objectives; manage the day to day priorities and goals of the department; maintain staffing levels and ensure staff development and training needs are met; ensure that work activities are based on returns on investments or other evidence of effectiveness; create plans for achieving long and short term objectives and financial goals; communicate on an ongoing basis department priorities, problems, and processes to a supervisor
Oversee the organization’s comprehensive case and disease management programs designed to contain costs and improve the health outcomes of members with chronic diseases; apply care management principles and understanding to implement member-focused case and utilization strategies using alternative settings and care practices whenever possible
Collaborate with internal and external resources, including other health care providers, to lead in the intervention and development of appropriate care planning; analyze data, including claims utilization and other relevant data sources, to develop medical management strategies that contain costs while maintaining high levels of quality care
Develop policies to support pharmaceutical care and services; monitor and analyze utilization and undertake initiatives to contain costs; ensure member safety and provide directions for contracts as required; meet the needs of Care Management in collaboration with the Network Contract Management Department
Maintain and compile a comprehensive understanding of Care Coordination, Case and Disease Management processes to establish metrics for trending, interpreting, evaluating and reporting results of day to day activities and performance management; lead, support and collaborate with internal resources to develop policies, procedures, strategies, and measures for achieving quality utilization and cost targets; identify variances to plan and implement solutions that improve performance, team efficiency and productivity
Maintain an awareness of and promote all rules and regulations governing the work performed within the health management and wellness areas; maintain compliance with regulatory and accreditation organizations at the local, state and federal levels, maintain the physical and technical security and privacy of protected health information
Oversee adherence to program standards and monitor performance of departmental interventions and outcomes related to programs including (but not limited to) the Duals Special Needs Program (Dual SNP) Model of Care, NCQA requirements for Complex Case Management and Disease Management, QARR/HEDIS, Medicaid Quality Improvement Project (QIP) and Chronic Care Improvement Project (CCIP)
Actively collaborate with IT, other customer care units and market relations to promote strategies and proposals that increase provider participation, membership growth and awareness of programs and services
Collaborate with Provider Relations to provide ongoing education to our Provider Network and customer care units utilizing a full range of facilitation and delivery methods on Quality Incentive Programs for members, Care Coordination, and Case Management
Develop effective working relationships with key providers and customer care departments; communicate to them the rationale and objectives of our programs, obtains their input, buy-in and feedback; continuously evaluate the impact of programs and efforts on our key providers and customer care units
Develop annual administrative budgets and lead, support and collaborate in the compilation and execution of auditing functions and preparedness
Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
Lead using a performance management and development process that provides an overall context and framework to encourage employee contribution and includes goal setting, feedback, and performance development planning
5-8 years related experience required

133

Associate Director Clinical Quality Resume Examples & Samples

Development and execution of clinical and quality strategies related HEDIS and Part D Stars improvements in partnership with Medicare Market CEO, Executive Director, data support, and other Optum and UnitedHealthcare parties as appropriate
Day to day leadership of the markets’ Medicare Stars results
Participation and leadership in provider meetings focused on HEDIS and Part D quality improvement (coordinating and working with direct reports, network management team, and local Medicare leadership)
Cross functional leadership and engagement with health plan, clinical care teams, and operations
Regular reporting and updates to senior leadership, including Health Plan CEO and segment clinical and quality teams
Development of PowerPoint and data packages
Leadership and support of achieving a minimum of 4 Star rating for market level Medicare & Retirement contracts and for achieving 85% of our members in 4 Star or better plans
Direct management of Quality Field team - Approximately 16 Direct Reports
Participation in health plan senior leadership team
Bachelor’s degree in Healthcare, Health Administration, Communications, Science, Business Administration or Finance (or equivalent education and experience)
3+ years of leadership experience (Manager or Director level) with a proven track record of exemplary leadership experience in the managed health care industry
2+ year front facing provider experience (preferably Stars related)
1+ year direct input/involvement in business strategy planning and development
2+ years of HEDIS, Stars and Risk Adjustment experience
Advanced technical skills for Microsoft Word, Excel, PowerPoint, Outlook, Adobe and Access
Proven record of strong analytic thinking capabilities
Must be located in NH, VT, ME, VA, PA but is a telecommute position
Travel (50%+) within above states
Demonstrated success, with a deep understanding of Health Care delivery operations and compliance, health care financing and industry trends
Strong negotiation skills; the ability to gain acceptance from others of a plan or idea and to achieve mutually beneficial outcomes
Strategic thinking capabilities
Quality Measurement and Medicare STARS rating program experience
Strong knowledge of electronic medical record systems
Consulting/sales experience a plus
Strong knowledge of the Medicare market
Strong problem-solving skills
Experience in managed care working with network and provider relations/contracting a plus

134

Director, Clinical Services Resume Examples & Samples

Day-to-day management of clinical operations and clinical client relationship, including evaluation of current priorities, allocation of resources to support daily and strategic objectives, and communication of client expectations to the account management and operations teams
Maintains efficient operation of the Beacon VA CCC Plus Clinical Program, including implementation and ongoing oversight
Enhances and develops clinical delivery systems
Develop, implement, and maintain operating policies, procedures, and performance standards
Monitors overall compliance related to contractual performance metrics related to completion of assessments, care plans and other required elements
Knowledge of the VA Medicaid Mental Health service delivery system
Proven ability to manage a clinical program through financial and clinical data analytics and trend analysis
Outstanding client relations skills with demonstrated accomplishments working with internal and external stakeholders
Ability to prioritize and manage multiple tasks simultaneously while meeting deadlines for deliverables
Excellent written, oral and presentation skills
Ability to manage and coordinate with internal departments and external agencies
Must be detail oriented; able to work independently in an ever changing environment

135

Senior Director, Clinical Svcs Resume Examples & Samples

Manages clinical services, across multiple offices in multiple states
Ensures adequate and appropriate staffing to support contract requirements
Reviews operational and performance metrics regularly and drives action plan development and execution
Works closely with other Clinical Operations team to ensure that monthly and annual targets are being met
Develops and maintains standardized outcomes and productivity reporting for all of clinical services
Develops and maintains standardized policies and procedures for all clinical services across all sites/locations
Provides oversight of appropriate data collection activities and reporting for Executive team and customer requirements
Supervises staff setting clear and consistent performance expectations
Develops and recommends strategies for targeting business opportunities and implements approved strategies to efficiently and effectively grow the business
Working with the Medical Director, develops internal review guidelines, operational clinical review processes and procedures to ensure contract deliverables while maintaining high quality and performance standards across all contracts
Develops presentations and other documents related to clinical services for customers or other internal customers
Serves as the SME in working with account management and teams on proposal/bid development as requested
Excellent interpersonal, communication and presentation skills
Able to multi-task and work on multiple projects simultaneously in a fast-paced environment while driving and meeting project timelines
Knowledge in and successful application of basic level of health care data analysis skills
Knowledge in and successful application of quality improvement skills in developing and implementing quality improvement programs
Active, unrestricted RN license preferred
Six Sigma Black Belt certification preferred, Green Belt required
10+ years’ healthcare leadership experience
Clinical review / utilization review experience preferred

136

Director, Clinical Affairs Resume Examples & Samples

Provide overall management for clinical trials as assigned
Manage all aspects of trial budgets, costs, and site payments
Originate clinical trial protocols and ancillary documents
Provide project/study management and monitoring plans for projects
Develop and maintain relationships with investigators, coordinators and site staff
Ensure conformance with GCP, ISO, MDD, CFR and other regulations as necessary
Investigate and solve problems that impact work processes and personnel in multiple departments
Ability to develop presentation materials and make presentations to senior staff
Assist with the planning, preparation and presentations at Investigator Meetings
Ability to multitask business, clinical, product and physician requirements
BS degree in life sciences plus 10 years of related work experience, MD or PhD preferred
Experience developing and executing clinical programs for medical devices, including prior clinical trial project management
Prefer MD orPhD. Minimum requirement: BS degree in life sciences plus 10 years of related work experience, or equivalent combination of education and experience
Prior people management and clinical trial project management experience required
Fluent in both written and spoken English

137

Director Clinical Services Resume Examples & Samples

Provide clinical leadership for assigned services based on Hazelden Betty Ford's standards of care, including integration of the multidisciplinary team, individual and group clinical supervision, monitoring of quality trends and implementation of quality improvement initiatives
Participate in strategic planning processes for designated clinical services
Maintain a qualified and competent staff to provide the clinical services and programs identified for professional services
Participate in customer education through lectures, individual information sessions and groups
Minimum of 5 years addiction experience using the 12 step model and multidisciplinary approach
Clinical supervisory experience
Five years leadership experience hiring, managing and leading high performing teams
Current license or certification as an alcohol and drug dependency counselor
Experience with mission and business perspectives, specifically in regards to balancing organizational mission priorities with effective business practices to promote program sustainability
Knowledge of license and regulatory requirements
Experience building partnerships with community services/resources
Experience in public speaking

138

Director, Clinical Excellence Resume Examples & Samples

A key responsibility is to assure ongoing progress toward SJHS Clinical Excellence Goals integrating methodologies to improve clinical quality while assuring compliance with external agencies and regulatory agency standards, integrating information from the Clinical Quality databases, coordinating CMS Partnership for Patients, Premier, IHI, NQF, HCAHPS/PRC and Leapfrog initiatives and other system-wide quality initiatives
Internal facilitation of best practices to achieve and sustain best practice for best benchmark performance and meet internal and external benchmarks
The Director is responsible for creating and performing orientation and educational programs in collaboration with regional and system PI experts for a continuous learning system that continues to build ministry capability and capacity for continuous improvement
The Director is also responsible for staffing the Quality Committee of the Board for Humboldt ministries and for other committees as requested. This position requires regular travel to local ministries to lead or coordinate meetings, activities, and resolve issues
Act as an agent on behalf of the best interests of the Humboldt; works to address special needs (e.g., disparities in care, health literacy, and employee safety), values and works to provide support and resources as needed
Analytic thinking and knowledge-based decision making: breaks problems down into parts or steps; (workflow) recognizes multiple layers of cause and effect; collects appropriate information to make decisions informed by available evidenced competencies and patient experiences and perspectives; values and supports transparency
Development of a knowledge-rich environment—supports continuous improvement/learning in the quality of data available to support decision making (collection, record keeping, access) by using emerging technology and methods
Help positionthe St. Joseph Health System, Humboldt County as the premiere hospitalrelative to key clinical/patient safety and patient experience outcomes. Examples of activities would includethe development of clinicalpathways with medical and hospital staff, benchmarking, participation in multi-hospital collaborative, and standardization of care to supportadoption and implementation for best documentation and ease of use
Able to balance competing priorities and balance clinical, operational and financial goals. Able to make a business case for changes in process or product in collaboration with other disciplines so that mutual goals are met or potential consequences for changes requested by Quality and Patient safety are weighed and mitigated in advance
PI Program management must include ability to rapidly respond to shifts in regulatory and accreditation requirements or emerging science through a nimble adaptive management style
Demonstrates SJH ethics and values and supports integrity in his or her professional conduct; considers the ethical implications of decisions; acts openly and transparently; develops a reputation as trustworthy/reliable
Ensures integration of the Hospital’s quality, financial, operational and strategicplanning processes to facilitate house-wide focus and achievement of performance improvement priorities
Fosters a climate that facilitates clear,fast, open and accurate communication regarding Performance Improvement (PI) and outcomesat all levels of the organization, with the Board of Trustees, Medical Staffs, and with the communities we serve
Creates an environment where
Proficiency in knowledge of data management, data governance and clinical analytics (internal and external) as well as data presentation
Excellent organizational skills especially when coordinating big projects, committees and special events, like CEU, CME
Idea championand effective change agent
Strong interpersonal skills to work with all levelsof employees, physicians and customers
Ability to create strong business partnerships
Strong facilitation and complexproblem-solving skills
Ability to maximizeoutput to multiple deadlines, while maintaining a calm demeanor
Demonstrated excellent verbal, written and presentation communication skills
Expert knowledgeof applicable accreditation and regulatory standards
Age-specific patientneeds that employee is required to understand and meet

139

Director, Clinical Analytics Resume Examples & Samples

RN, Doctor of Pharmacy or MD required
Five to ten years designing and overseeing clinical analytics in a healthcare setting, preferably a health plan or health plan analytics department
Must be clinically focused. Experience with SAS Enterprise Guide, extensive knowledge of medical and pharmacy reference data sources and their appropriate utilization. Experience with medical and pharmacy claims analytical methodologies

140

Medical Director, Clinical Skills Center Resume Examples & Samples

Direct the overall administration, programming, delivery and quality assurance of services offered by the Clinical Skills Center
Develop short and long range plans for program expansion and resource acquisition to ensure best practices in the use of simulation resources (standardized patients, low and high fidelity simulators and task trainers) for academic programs within the school, partner organizations and interprofessional initiatives
Design a multi-year clinical simulation curriculum to teach students and assess expected competencies and assure graduates meet school and national accreditation and certification standards
Provide clinical expertise and participate in the development of all SP cases, simulation clinical encounters and assessment instruments in collaboration with course directors
Actively engage in student and resident education and the development and remediation of their clinical skills
Participate in faculty development on the use of simulation, debriefing and innovations in clinical education
Provide clinical expertise in the training of standardized patients
Supervise staff and faculty involved in the delivery of center programs and services
Oversee the collection of data on learning outcomes and participate in preparing reports on program activities, outcomes and student performance; quality assurance monitoring; accreditation requirements; and other related reports
Direct the center budget, operations, staffing, space and the purchase of technology in collaboration with the Administrative Director
Work with RowanSOM foundation to seek funding and grant support for center expansion and new programming,
Collaborate with Information Technology professionals to design and deliver onsite, web-based or distance learning simulation experiences
Promote and collaborate in research and scholarly work in the field
Perform other all duties as assigned
Medical Degree (DO or MD or equivalent degree)
Must be able to obtain a New Jersey Medical License
Experience in medical education and curriculum development
Experience with use of an audio-video/textual data capture application for simulation, such as CAE Healthcare’s LearningSpace or similar
Exceptional leadership, organizational and problem solving skills
Excellent written and interpersonal communication skills
Meet all qualifications for holding a faculty position in the appropriate clinical department

141

Director / Clinical Services Resume Examples & Samples

Working knowledge of the business of healthcare; hospice, home care, or DME background is preferred
Ability to plan and schedule projects and facilitate/coordinate projects through teams across departments
Strong written and verbal communication skills with demonstrated facilitation skills
Skill and proficiency in standard software programs including but not limited to: Microsoft Word, Excel, PowerPoint
Work will require excellent analytical and statistical skills with ability to read, interpret, and apply complex guidelines
Ability to lead and motivate individuals and groups toward the accomplishment of organizational goals
Skill in negotiating with and between individuals and groups of people, including Associates, management and physicians
Ability to plan and schedule tasks and projects to maintain control of work flow
Skill in developing and implementing long term plans and programs
Ability to work without close supervision or professional guidance and to exercise independent judgment

142

Director, Clinical Operational Informatics Resume Examples & Samples

Transformational Leadership
Quality and Innovation
Graduate of an approved school of nursing for registered nurses, BSN required
Master's Degree in Nursing, Management Information Systems/Business Administration or other healthcare related field required
Requires five years relevant experience in nursing, management or clinical information technology experience including two years in an academic medical center or large, complex healthcare organization managing cross functional teams, projects, and influencing key leadership stakeholders
Comprehensive knowledge of healthcare information systems and understanding of clinical applications and related technologies, preferably with the Cerner system or another advanced electronic medical record system is necessary
Demonstrated experience in nursing informatics
Demonstrated experience with project management approaches, tools and phases of the project lifecycle
Exceptional communication skills-both written and verbal
Able to work effectively at all levels in an organization
Problem solving and root cause identification skills
Strong analytic and decision making abilities
Must be a team player and able to work with and through others
Ability to influence others and move toward a common vision or goal
Experience with large-scale organizational change effort

143

Director, Clinical Pharmacogenomics Resume Examples & Samples

Lead a small team of scientists responsible for developing pharmacogenomic plans to support clinical programs
Oversee the analysis of clinical genomics data to generate genomic biomarker hypotheses for asset teams
Translate clinical/real world data into targeted hypotheses; connect insights to early and late stage programs, to inform the pharmacogenomic plans
Support clinical project teams in the design, implementation and interpretation of pharmacogenomics strategies
Develop and improve processes and infrastructure to support a world class clinical pharmacogenomics operation
Partner with key Biogen stake-holders: clinical development, COE/Biomarkers, Worldwide Medical, Value Based Medicines, asset teams, regulatory, safety, biostats, RED Research Units and IT to ensure alignment and prioritization of plans
Initiate and manage external collaborations to support Biogen in the area of pharmacogenomics, genomics and precision medicine
Contribute broadly to the leadership of CBG and the RED CoEs at Biogen to develop strategies that fully integrate genomics and other biomarker technologies across the R&D pipeline
Ph.D. in a relevant scientific discipline and/or technology area and/or M.D. is required
At least 8 years of post-graduate experience with biological and/or medical data sets and 3+ years of experience analyzing large data sets with advanced analytics approaches
Deep experience with the analysis of biomarkers (including genomic and or genetics) and clinical data sets required. Experience working with electronic medical records (EMRs) and image data desired
Knowledge of the pharmaceutical drug discovery and development process with a strong track record of delivering impact on either the R or D side of the business is required. Experience in both pre-clinical and clinical drug development is desired
Pragmatic leader with a focus on value-creating activities and a track record of creativity, innovation, and delivery of real world value, including relevant peer-reviewed scientific publication, is required
Demonstrated ability to work collaboratively with research project teams and/or clinical development program teams is required
Excellent communication and presentation skills are required. Ability to translate complex statistical/informatics terminology in such a way that scientifically trained individuals can readily understand their significance is required
A track record of leading a technical team and developing staff as individuals and leaders is required

144

Director, Clinical Program Management Resume Examples & Samples

Oversee the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving clinical program objectives; Accountable for Early Engagement process with Strategic Partners
Oversee Clinical Program Managers assigned to represent Clinical Operations as members of the Global Project Team (GPT) and/or Clinical Subteam(s) (CST), working closely with GPT Leadership to ensure program objectives are met
Represent Clinical Operations for assigned program in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees
Accountable for program budget planning and external spend related to program execution. Works closely with Clinical Program Managers, Project Management, and Finance to ensure budgets, enrollment, and gaiting are accurate; ensures communication of program status, cost and issues to inform timely decision-making by senior management
Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees when warranted; accountable for operational risk management strategy in collaboration with Strategic Partners
Provide TA-level direction to clinical program manager(s) for the development of operational plans including enrollment models and , risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; accountable for inspection readiness
Provide TA-level direction and/or contribute directly to due diligence projects across the therapeutic area
Accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate
Collaborates with and is responsible to the Global TA Clinical Operations Lead to ensure adequate clinical operations resources are assigned to program
Support functional strategic initiatives and processes managed by Clinical Development Services Group
Act as a role model for Takeda´s values
Line Manager Clinical Program Managers
Provides expert counsel for issue resolution, including projects assigned to other staff, when required
Able to assist in role of Global TA Clinical Operations Lead as required
Demonstrated excellence in project/program management and matrix leadership
Fluent business English (oral and written)
10+ years experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study management
Experience must include Phase 2 and 3 studies and global/international programs
Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals

145

Associate Director Clinical Bioanalysis Resume Examples & Samples

Propose project-specific bioanalysis strategy according to project needs and regulatory guidances,
Manages regulated bioanalytical assay development, validation and sample analysis
Writes/reviews bioanalytical components of clinical study protocols. Reviews bioanalytical data (quality oversight)and reports from quality and compliance perspectives
Contributes to NDA (summarizing BA methods and studies, and write relevant sections in NDA package)
Contributes to functional process improvement (revise and/or propose better practices that can improve compliance and efficiency, drafting guidelines)
Executes ex-vivo/in-vitro studies to enhance clinical development
Manages and maintains project-based relationship with laboratory with supervision
May provide mentorship or people development

146

Senior Director, Clinical Effectiveness Resume Examples & Samples

Serves as the point of contact for RFP and bid content for clinical, medical and quality organizations for the designated business segment and ensures that the model of care program integrity, staffing models, and interdisciplinary dependencies are tracked and monitored. Works closely with Business Development writers to ensure current model of care constructs are translated, accurately reflected and subsequently priced appropriately
In lock step with the designated CMO(s), directs, coordinates and evaluates Medical Director efficiency, quality, and productivity. Organizes monthly and annual medical director conferences. In collaboration with national clinical teams, assures that all Medical Director functions within utilization management, disease management, and case management activities meet the standards required for the state and federal requirements, client contracts, and NCQA and URAC accreditation standards
Leads and organizes the ongoing evaluation of the medical management program against quality and utilization benchmarks and targets for behavioral and physical health clients. Identifies opportunities for improvement; organizes and manages cost of care initiatives in partnership with Medical Directors and designated operations and network teams. Collaborates with local and national leaders including Quality, Clinical Analytics, Finance, Network, and other areas to assure a comprehensive approach to managing quality of care, service, and cost of care. Provides expert input to Finance regarding patterns of utilization and cost and high cost cases as tracked through Medical Director activity
In partnership with the designated CMO(s), assures staff hiring, selection, training, and evaluation to promote the development of a high quality team, interventions, and effective care protocols (i.e.: rounds) with the clinical care, quality, and operations teams
Works closely with and provides input to national health plan and / or designated business segment clinical teams on RFPs, public presentations, ACO development, value based purchasing models, program design, policies, procedures, workflows, systems, evaluations, and correspondence
Assures inter-rater reliability and audit processes are met, and corrective actions are operationalized and implemented in daily operations for Medical Directors for processes affecting cost of care and medical management. Responsible for resolution and communication of Medical Director issues and concerns and corrective action plan activities and reporting

147

Associate Director Clinical Quality Resume Examples & Samples

Providing business analysis and interpretation of quality measure specifications to technical teams in the deployment of quality measures; mentoring business analysts to do same
Creating methodology solutions based on healthcare data
Leading efforts to improve product testing, validation and documentation activities
Engaging with customers to define scope and clarify requirements for requested work
Answering questions; providing subject matter expertise, training, and detailed documentation to clients
Performing complex analysis of client data to troubleshoot client issues
Strong attention to detail and accuracy to perform job tasks
Excellent written/oral communication and listening skills communicating internally and cross functionally with leaders and customers
Experience implementing aspects of national quality measures (through provider groups, payers, state/federal institutions), such as HEDIS, Medicare Stars, PQRS, Meaningful Use, State Medicaid programs; this experience could include quality improvement initiatives, reporting, EHR/Practice Management data analysis, etc
2+ years working on projects or products that fell into a product or project lifecycles
2+ years performing data analysis or business analysis
5+ years of experience working in the healthcare industry (for example in a clinical, managed care, or care management setting)
Working knowledge of administrative claims data and medical coding systems (i.e. CPT, HCPCS, ICD-9, NDC)
Intermediate skill with Excel - must have ability to work without assistance creating spreadsheets, utilizing formulas, etc
Location available for this role is Minnetonka, MN - consideration will be given to those outside of the state if willing to relocate
ICD-9, ICD-10, CPT, and HCPCS coding experience
Understanding of clinical taxonomies (SNOMED, LOINC, RxNORM, etc.)
Experience writing queries in analytics tools such as SQL or Microsoft Access
Knowledge of relational database structures
3+ years of experience managing a team of employees including resource planning and hiring
Experience with managing budgets, financial reporting, and forecasting

148

Director, Clinical Management Resume Examples & Samples

Hiring Requirements
Significant clinical research experience (comparable to over 10 years experience)
A demonstrated track record of success in leading and managing professional staff
Or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
Health Science degree
Experience in global clinical trials
Proficient knowledge of medical/therapeutic area and medical terminology

149

Director, Clinical Laboratory Resume Examples & Samples

Bachelor's degree in Medical Technology or related science. Master's degree preferred
Five (5) years of clinical laboratory experience with at least two (2) years in a supervisory position is required
Certification from the American Society of Clinical Pathologist (ASCP) or National Certification Agency (NCA) required
Mathematical, computer, reasoning, and language skills at the undergraduate or graduate level is preferred

150

Senior Director Clinical R&D Resume Examples & Samples

Define and develop Target Product Profiles and Integrated development strategies
Design and optimize clinical trial design and to ensure clinical trials meet ethical and regulatory standards
Lead Clinical Development programs and interact with other functional areas such as Discovery, Safety, Marketing, Regulatory, Research and other functions
Responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports
Work with cross functional team members to prepare abstracts, manuscripts and presentations for external meetings
Author clinical sections of regulatory documents such as INDs, Investigator Brochures, CTAs, ISE’s, Clinical overviews, Health Authority responses, PSUR, and DSUR
May participate as clinical representative on multidisciplinary Project Teams

151

Director, Clinical Flow Cytometry Resume Examples & Samples

Delivers high quality flow cytometry based biomarker assays for target engagement, pharmacodynamic endpoints and patient selection
Ensures that analytically validated fit for purpose assays are developed and delivered to support early clinical development
Manages internal and external laboratories for whole blood/PBMC sample processing and flow-cytometry based analysis
Make critical strategic decisions to forecast and manage the demand of flow-cytometry assays, including viable outsourcing strategies that maximize delivering clinical data on time with high quality, while minimizing risks to development programs
Manages a complex series of relationships with external vendors, in conjunction with a matrixed team at BMS, to ensure that vendors provide assay validation and sample results according to transferred methods and procedures
Oversees the quality of transferred assays and ensures that results from both internal and externally sourced assays are provided in real-time to support decision making in clinical trials
Ensures appropriate CLIA certification for flow-based patient selection assays as necessary
Understand, implement and ensure good clinical laboratory practices
Be responsible for the career development and performance management of a group of 10 -20 researchers with varying levels of experience and responsibilities in the flow laboratory
Provides both strategic and tactical direction, and resource prioritization, as well as acting as a resource for troubleshooting as necessary
Provides biomarker expertise to the Center of Excellence in Pharmacodiagnostics and partners to progress appropriate validated biomarkers into diagnostic development. Leadership & Matrix Alignment
Acts as an active contributor to the Biomarker Technology matrix team, continuously seeking opportunities to optimize interfaces and processes to delivery highest quality biomarker data to clinical programs
A Ph.D. in Biomedical Sciences. Immunology or Oncology a plus
Minimum of 8 years experience beyond post-doc
At least 5 years of experience in an industrial setting. Within diagnostics or translational biomarker setting a plus
Demonstrated excellence in managing flow cytometry research projects
Familiarity with the techniques common to translational research including flow cytometry, genomics, proteomics and importantly, data analysis
Experienced manager of people and projects
Ability to interact well with senior managers and develop and articulate a strategy for translational research
Understanding of good clinical laboratory practices
Familiarity with CAP/CLIA regulations a plus

152

Director, Clinical Statistics Resume Examples & Samples

MS in statistics or related field with minimum 10 years pharmaceutical or related experience or
PhD (or equivalent) in statistics or related field with minimum of 7 years pharmaceutical or related experience
Experience in design, execution, analysis and interpretation of clinical trials
Strong statistical capabilities with wide breath of statistical expertise including proven ability to provide both bespoke statistical and data mining solution to complex problems and hand-on programming experience to execute these analyses
Candidate to have a solid understanding of development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and business objectives
Experience with Bayesian methods
Excellent interpersonal and communication skills, with
Track record of statistical contributions, commitments and accomplishments in clinical drug development
Proven ability to organize workload and competing priorities, and complete tasks on time. Proven ability to successfully lead and manage other statisticians in a clinical development organization
Clinical pharmaceutical industry experience with a working expertise as well as a proven track record of successful application of both frequentist and Bayesian-based methods
Ability to effectively communicate to matrix team members, putting information into context
Proactively provide strategic input in clinical development programs and facilitate communication among fellow staff members, and across Clinical Statistics to take advantage of knowledge gained on individual projects to share best practices, innovative designs and methods, therapy area knowledge, and continual improvements in efficiency
Experience in working with, and coordinating the work of contingent workers and CROs
Demonstrated ability to influence and contribute strategically to the broader statistics organization
An analytical and inquisitive mind with a proven track record for problem solving
Well honed written and oral communication skills are essential
A proven ability to build effective and trusting relationships with the members of interdisciplinary matrix teams
A proven ability to build powerful networks within and outside the company and use these relationships to achieve support for the planning and implementation of innovative approaches

153

Director, Clinical Engineering Resume Examples & Samples

Master’s Degree in biomedical engineering, electrical engineering or a related technical field required. PhD is preferred. CCE certification, or similar preferred. An MBA, or Master’s Degree in another related field can be considered for individuals with relevant technical experience and undergraduate education
Eight (8) years professional experience in the field of clinical engineering, or equivalent related experience in an electronics field is required
In addition, five (5) years of progressively responsible supervisory, budget formulation and execution, and management experience is required
Knowledge of the engineering and application of key clinical technologies such as CT scanners, MRI’s, ultrasound, used in health care diagnosis and treatment sufficient to engage substantively in strategic and tactical discussions with subject matter experts on their use, efficacy, physical and operational characteristics, strategic value, acquisition and operating costs
Comprehensive knowledge of The Joint Commission, local, state, federal codes, building codes, industry standards in medical equipment and clinical engineering fields is required
Successful experience leading the planning, selection and adoption of new technology in a medical environment
Knowledge of computer-based automated asset management systems is required. Demonstrated knowledge of microcomputer applications, including word processing, graphics, spreadsheets, and data management is required
A high level of proficiency and demonstrated effectiveness in problem solving and implementing new programs related to increasing departmental and organizational operating efficiency is required. Highly effective interpersonal skills are needed to manage multi-trade teams and interact effectively with clinicians at all levels in the organization
Highly effective verbal and written communication skills are required to work successfully with a diverse group of staff at all levels within the organization, including executive management and the Board of Directors

154

Director Clinical Trial Management Resume Examples & Samples

Previous senior leadership position in Clinical Research
At least 10 years’ experience in clinical trial management; preferable with a CRO
This position is office based in Cambridge, MA

155

Director Clinical Trial Management Resume Examples & Samples

Minimum of Bachelor’s degree; Master's degree or PhD preferred
A minimum of 10 years experience in the clinical research industry, with at least 5 years' experience in clinical trial management (preferably with a CRO)
This position is office based in Cincinnati therefore relocation to Cincinnati is required

156

Director Clinical Admissions Resume Examples & Samples

Aggressively seek out potential clients and facilitate referrals into Genesis HealthCare service locations
Triage clinical cases in "Yellow" or "NonStandard" criteria to appropriate Area designee,
Respond to referrals based on published productivity/performance standards
Identify opportunities for and threats to business and communicate this information to appropriate personnel
Use Genesis technologies to document activities; submit reports and summaries in compliance with policy
Other related duties and responsibilities

157

Executive Director, Clinical Quality Resume Examples & Samples

Along with the Medical Director, co-leads the Clinical Quality functions of The Federation and CMI
Provides vision and leadership to Clinical Quality staff
Provides strategy, leadership and support to the Federation of Permanente Medical Groups for clinical quality and care management initiatives
Provides leadership of the Kaiser Permanente National Quality Committee (KPNQC) planning group, and KPNQC support team, the National Permanente Quality Leader Committee and the Permanente Quality Board
Oversees the leadership and support of various national and interregional clinical practice groups to facilitate the design, development, and implementation of clinical quality and care management initiatives
Leads Clinical Quality Federation and CMI programs and initiatives
Collaborates with other appropriate interregional KP units
Facilitates interactions with other relevant KP units, especially other PO Quality Departments
Leads and staffs major and complex program wide health programs and initiatives with strategic importance to KP
Provides expert consultation to leadership for clinical improvement initiatives, leveraging key relationships with Permanente Medical Group, region and Program Office leaders
Provides new views and insights on clinical practice improvement specific to quality, safety, service, and affordability
Leads interregional physician specialty and multidisciplinary groups to address quality, safety, service and affordability aspects of clinical care and practice
Provides leadership and management for cross-regional initiatives to drive reductions in clinical practices variations and standardize successful clinical practices
Part of the leadership team for CMI, partnering across Medical Group entities with Health Plan and Hospital groups
Supervises Directors and project management staff in The Federation and CMI for leadership and support of interregional physician specialty and multidisciplinary groups, related projects and support
Works closely with Federation and CMI Directors and colleagues to set strategic direction and framework of projects
Overseeing/managing Quality functions staff and budget resources to optimize contribution to quality, safe, accessible and affordable care
Minimum fifteen (15) years of experience in the health care field
Minimum ten (10) years of complex multi-specialty medical group, hospital management and managed care experience
Regional and Program Office experience within Kaiser Permanente
Experience in healthcare performance improvement
Experience with Patient and Family Centered Care
Experience in resource stewardship

158

Director Clinical Quality Resume Examples & Samples

Develop model of clinical supervision for nurses and medical assistants and/or other clinical support personnel in coordination with the medical directors and managers
Ensure nurses, medical assistants and/or other clinical support personnel are appropriately oriented, trained, and demonstrate competency within their scope of practice
Develop systems with managers to ensure orientation, competency training and monitoring
Manage quality dashboards and performance on quality metrics, such as Boeing quality metrics and HEDIS 5-Star quality metrics for Medicare Advantage
Develop, implement and standardize clinical workflows to meet or exceed quality targets (including clinical quality measures as well as patient satisfaction and employee/provider engagement targets)
Patient Safety Coordination: Regularly track and monitor patient safety publication, list serves and web based materials. Help to identify and anticipate future patient safety initiatives; Take a lead role in coordinating patient safety initiatives across provider and staff teams consistent with the goals and priorities established by Providence Health & Services and specifically Providence Northwest Region
Oversee development of incident, events, and near miss case review in conjunction with the Chief Medical Officer, medical directors and clinic managers. This includes daily response to high harm scores, systematic review and reporting of trends, and recommending strategies for improvement
Serve in lead role in coordinating and facilitating Leadership patient safety rounds and lead role in implementing High Reliability processes and work throughout the Medical Group
Ensure clinical policies are current, approved by the medical leadership, implemented, and monitored for quality outcomes
Lead collaborative efforts in working with inpatient and outpatient shared patient safety functions (inclusive of patient satisfaction and High Reliability work processes and initiatives)
Chair respective Quality, Safety and High Reliability Committees and other committees as assigned
Provide education and training opportunities for nurses and medical assistants in partnership and conjunction with our Clinical Nurse Education team
Assist managers in specific operational issues related to quality and scope of clinical practice
Five years of supervisory/management experience (or equivalent work experience with progressive leadership)
Experience in ambulatory nursing
Experience in quality, safety and clinical practice
Experience in producing positive outcomes from collaborative work with medical leadership

159

Co-block Director, Clinical Anatomy Resume Examples & Samples

Assist in the organization of Block material
Assist with identifying and recruiting guest instructors
Be available as a student contact for clinical questions related to Block material
Review mid-block and end of block evaluations and provide input as to how the Block should or should not be altered for the subsequent year
Write and review exam and practice questions, attend exam review sessions, and assist with responding to student exam question challenges
Assist with exam set-up and proctoring
Teach in all block sessions, including overseeing small group exercises and dissections of the willed body donors
Attend and participate in instructor meetings immediately following class
Provide assessment for assigned students for appropriate competencies
Attend the annual Ceremony of Appreciation
Attend Block/Course/Theme meetings (BCT) if possible
MD or DO (or equivalent)
Teaching experience in a gross anatomy laboratory at the undergraduate medical student level
Experience in medical school course administration
Experience with multiple teaching methods including lecture, lab, independent learning modules, and team based learning in the medical school environment
Experience writing USMLE style exam questions

160

Director, Clinical Quality Resume Examples & Samples

Leadership.Responsible for hospital and system-wide coordination and standardization of all aspects of clinical quality, performance improvement, and process redesign through collaboration with hospital, nursing and medical staff leadership. Leads, supports and mentors quality professionals
Project Management.Tracks departmental and strategic performance improvement initiatives to ensure that objectives are met and recommended actions are fully implemented. Implements the necessary processes to ensure compliance with the New York Patient Occurrence Reporting and Tracking System (NYPORTS)
Quality. Provides technical support for quality improvement activities of clinical departments and units, specifically providing improvement teams with the necessary tools and approaches to improve measures of quality and safety. Ensures that any corrective or preventative actions are thorough, appropriate, and fully implemented to reduce risk and improve patient safety

161

Division Director Clinical Documentation Resume Examples & Samples

Act as manager support for the staff positions for the department
Train and mentor new staff hired, including onsite assistance at request of Division CFO
Conduct onsite training and updates as needed to staff in all 4 markets and float to market based facility assignments as needed
Conduct initial and extended-stay concurrent review on selected inpatient admissions to assess for appropriate clinical documentation that reflects the services and procedures received by the patient
Document findings on current clinical documentation system on a daily basis
Identify co-morbidities/complications and obtains appropriate chart documentation from physicians to support these conditions
Obtain clarification of clinical documentation daily, querying the medical staff via written/verbal communication to obtain complete and accurate documentation, advocating for appropriate DRG assignment, for the patient care resources consumed and the level of service rendered
Utilize critical thinking skills to identify documentation issues such as quality, appropriateness, completeness and reimbursement issues and communicates these issues to physicians and other caregivers so that immediate resolution can be made in medical record documentation
Act a liaison for documentation efficiencies with Health Information Management, Case Management, Ancillary Departments, Physicians and Senior Management
Demonstrate knowledge of DRG payor issues, appropriate DRG assignment alternatives, and clinical documentation requirements
Conduct daily follow-up reviews of clinical documentations to ensure points of clarification have been recorded in the patient’s charts
Review clinical issues when appropriate with coding staff to determine a working DRG and/or clarification of documentation as needed
Develop training materials and tools to conduct ongoing clinical documentation education sessions for physician and other hospital personnel
Identify documentation trends and issues for individual physicians and reports these to the Case management Director, HIM Director and/or Quality Director for any appropriate peer review follow up monthly
Registered Nurse with current Florida License required
More than 7 years hospital clinical experience with 2 years clinical chart review experience

162

Associate Director, Clinical Trial Management Resume Examples & Samples

Delivers high quality clinical trial deliverables on time and within budget
Performs job duties with minimal guidance
Develops work plans, establishes clinical research objectives, assigns tasks appropriately (aligns skill sets with assignments.)
Maintains schedules (timelines) for overseeing assigned clinical research studies and drives decision making to ensure adherence to timelines
Provides guidance to Clinical Team through setting clinical research goals aligned with department policies and standards
Identifies and recommends changes to practices and policies
Directs activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
Acts as a point of escalation for internal and external team members
Communicates operational aspects of studies in each project throughout the organization
Contributes to clinical development planning and life cycle timelines
Acts as the point person for information on status of different projects in program
Develops and provides challenging yet appropriate assignments and communicates progress toward development goals
Leads, guides and mentors CTM staff
Must be able to effectively communicate to all levels of the organization, including senior management
Analytical problem solving experience
Must be able to develop and present varied and unique ideas
Must have broad knowledge and cross-functional understanding of clinical trial methodology

163

Director, Clinical Engineering Resume Examples & Samples

Lead a team of three managers who oversee a staff of more than 50 individuals who provides project, maintenance, and elbow support to employees of UMMC
Collaborate across organizations coordinating with UMMS Information Technology on projects for deployment programs at UMMC
Support system projects as the director oversight of the UMMS radiology technology team
Represent UMMC as a leader by attending UMMS council meetings where technology initiatives within the system are discussed

164

Director, Clinical Trial Patient Advocacy Resume Examples & Samples

Develop and maintain strong relationships with key disease-based and minority-focused advocacy organizations, and leverages these relationships to remain informed and achieve goals related to the ongoing support of compounds in clinical development, specifically around clinical trial recruitment
Collaborates with advocacy groups around key issues related to clinical trials, drug development, and patient awareness
Develops strategies and tactics to engage patients, caregivers and advocacy groups in the development of protocol design and study operationalization
Proactively brings the “Voice of the Patient” to the Clinical Teams to ensure that barriers that may prevent study enrollment are discussed, and to ensure that solutions are identified
Development, management and execution of voice of patient plans/playbook at disease and/or compound level to support well integrated site and patient centric patient recruitment program
Partner with Corporate advocacy group to build and enhance relationships with advocacy , community and diversity groups to raise awareness of Celgene clinical trial portfolio
Ensures that the data generated by Clinical Trial Planning and Analytics (CTPA) group & feasibility activities is adequately interpreted and leveraged in serving as foundation for identifying patient advocacy opportunities
Works closely with the Clinical development, Lead AD/D, Trial managers, MSLs, commercial, e-business etc. for understanding and development of patient journey that will support patient recruitment plan and to ensure smooth flow of information and coordination of activities to optimize site and patients engagement for clinical trials
Conducting and leveraging lessons learned emerging from use of innovative patient recruitment, retention and engagement strategies to formulate recommendations for optimal use of these emerging principles
Fosters a collaborative, innovative, problem-solving culture and mindset
Provides training in patient advocacy and clinical research engagement for team members (as applicable)
Provide regular communication and updates to all relevant stakeholders
Support scientific / educational local meetings for site personnel (as applicable)
Establishes and fosters relationships and professional contact with investigators, advocacy groups, consultants and vendors as needed
Study stakeholder management KOLs, Patient Groups on a needs basis
Ensures that all activities meet regulatory requirements and are conducted to GCP standards
Effectively participates in project teams and company-wide committees
Acquires knowledge related to drug development program, clinical trials methodology and clinical operations as needed
BA/BS degree or equivalent
More than 7 years in patient advocacy and/or a combination of patient advocacy and clinical drug development in the bio-pharmaceutical industry and strong experience in managing relationships with advocacy and diverse groups
Strong team player, willing to share information and ideas
Knowledge of GCPs and ICH guidelines and clinical operations
Ability to travel with overnight stays, as necessary
Ability to effectively work in a global environment
Ability to interface professionally with a wide spectrum of internal and external professionals
Ability to work on multiple projects with aggressive timelines
Ability to demonstrate operational excellence, innovative thinking, scientific mindset and strategic thinking
Good understanding of regional regulations
Knowledge in clinical trials methodology
Bilingual skills (e.g. Spanish), would be highly beneficial

165

Director Clinical R&D Lead Resume Examples & Samples

MD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology
Minimum 3 years industry experience or minimum 10-years experience working in a scientific or medical institution, prior experience as Principal Investigator, Medical Monitor or commensurate to Clinical Research Scientist position
Good theoretical and practical knowledge in clinical research. Previous vaccinology experience highly desirable
Role requires the ability to translate scientific skills in the field of vaccines and clinical research into business driven strategies
Understanding of GCP and ICH guidelines; experience working with Regulatory functions (i.e. filing IND, BLA, CTD) a plus
Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills
Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence
Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP
Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape
Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum
Strategic thinking skills and achievement oriented
Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks
Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making
Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences
Excellent knowledge of spoken and written English
License to practice medicine and board and/ or professional certification is an asset
Participate at a senior level in Clinical Development activities for a series of studies within a large program or group of related programs or, for a mid-size program, lead Clinical Development activities
Where applicable, lead matrix team, to author clinical development plans, design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability will be to Clinical and Epidemiology Research & Development Project Lead (CEPL)
Responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CEPL
Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report
Where applicable, support or act as the delegate of the Clinical and Epidemiology Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed
If applicable, represent clinical development within Vaccine Development Team (VDT), Vaccine Commercial team (VCT), Discovery Performance Unit (DPU,) Protocol Review Board (PRB), Toxicology Working Group (TWG), etc
If appropriate, support the CEPL or serve as delegate of the CEPL as the principal liaison to Independent Data Monitoring Committee (IDMC)
Serves as a scientific and management reference for the project (internally/externally)
Supports internal process improvement activities and initiatives involving coordination of multidisciplinary working team across departments (clinical, safety, regulatory) and maintains contacts with internal and external stakeholders (e.g., Brighton collaboration working group, CDC, and others)
Assumes accountability for the medical/legal and human safety aspects of the clinical program. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer)
Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program
Address scientific and medical issues related to one or more projects. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals
Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), on clinical program level accountable for. In clinical programs, together with PV analyse safety and potential signals and escalate accordingly
Publishes clinical data in peer review journals and presents in external scientific meetings / congresses
Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology
Budget, resourcing and timing
Supports the clinical team to consistently achieve high standards in attainment of project timelines in global programs
Interfaces with the PDL to ensure milestone realization and resource optimization
Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety)
Supports or Leads the Clinical Project Team(s)
Support or leads one Clinical Project team (matrix teams including, but not limited to, CRDL’s, Science Writers, Biostats, SDLs, and Study Data Managers) with a spirit of creativity and instills optimism and a can-do attitude
Provides formal feedback, which encourages team member develop their skills. Provides performance feedback on matrix team members to responsible line managers
Enhances the knowledge level of the entire team by developing project-specific training programs
Consistently displays creative and innovative leadership skills while working in a matrix team
Provides support to Marketing/Business Development throughout product life cycle
Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development as applicable
Provide medical support to Marketing in order to achieve Company’s objectives
Actively follows-up the product-related Environment
Responsible for follow-up of project related literature, discussions with external experts and authors, participation in congresses and presenting GSK data
Reviews and approves labeling and related promotional materials where applicable
Within Clinical RDC, contributes to provide leadership, direction and vision for the team of CRDL function
Provides input and participate in the recruitment and development of the team of CRDLs within Clinical RDC
Build and foster the establishment of a CRDL community
Serves as mentor in line / matrix reporting setting with an active interest in the leadership and technical development of team members
If applicable, provides operational and administrative management to the Clinical RDC. In this capacity, manage direct reports (objective setting, performance assessment, career development); mentor and train junior CRDLs

166

Associate Director, Clinical Laboratory Resume Examples & Samples

Monitor laboratory operations in order to verify that accurate, precise, and medically-reliable data are being generated
Interact with corporate leadership, administration, government agencies, accrediting agencies, and potential sponsors/clients to gain information and knowledge required to make appropriate business and/or operational recommendations and decisions; and
Oversee multiple technical areas of the central laboratory
PhD Genetics, Oncology, Immunology, or other similar areas; and
Experience with sequencing technologies and bioinformatics pipelines; and
Experience with other molecular technologies; and
Experience in a Central Laboratory setting preferred

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