Manager, Clinical Resume Samples

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A Mante

Araceli

Mante

96522 Wehner Union

Los Angeles

+1 (555) 878 1634

96522 Wehner Union

Los Angeles

Phone

p +1 (555) 878 1634

Experience Experience

Boston, MA

Manager, Clinical Services

Boston, MA

Jerde Inc

Boston, MA

Manager, Clinical Services

With support, from the Assistant Manager of Clinical Services, manage the Clinical Team of 15-17 coaches and enrollment personnel
With the Assistant Manager for Clinical Services, manage the day-to-day operations of the Clinical Team
Work with the Community Development Team Manager to coordinate efforts related to the proactive fax referral program
Develop and implement quality and productivity standards then establish the expectations with the staff in the performance of their jobs
Guide the Assistant Manager of Clinical Services in schedule management for services coverage
Facilitates the development of working relationships, which enhance team and individual performance to achieve best practice
Provides assistance with clinical system enhancement request, testing and training

Detroit, MI

Manager, Clinical Documentation

Detroit, MI

Walsh-Collier

Detroit, MI

Manager, Clinical Documentation

Works effectively with the Coding Manager/Coding Auditor to improve coding services provided by the coding staff
Assist the CDIS Director monitor the quantity and quality of work performed by the Clinical Documentation Improvement Specialist team
Assist with performance improvement projects to identify key drivers for selected populations and/or evaluate trends of concern
Lead performance improvement initiatives to improve clinical documentation and/or coding
Teaches Clinical Documentation Improvement Specialists clinical documentation improvement techniques, processes and tools
Participates in the analysis and trending of statistical data for specified patient population to identify opportunities for improvement
Provides CDC leadership for audits/inspections in partnership with Operations and functional stakeholders

present

Phoenix, AZ

Senior Manager, Clinical Development

Phoenix, AZ

Kunde, Watsica and Schuppe

present

Phoenix, AZ

Senior Manager, Clinical Development

present

Providing Clinical Development oversight on clinical development aspects for ongoing clinical trials
Develop project timelines (utilizing Microsoft Project software), study budgets and project management plans. Report project status to senior management
Works with business development to identify and select consultants, vendors, contract research organizations (CROs), etc
Managing the project‐related clinical development budget with the Clinical Sub‐Team and Project Manager
Forecasts and manages study-related finances within established budget parameters and communicates project status to clinical team
Perform periodic review of TMF/eTMF to ensure accuracy and completeness. Assist with archive TMF/eTMF following study closeout
Communicating project progress to their line function managers

Education Education

Bachelor’s Degree in Behavioral Health

University of Central Florida

Bachelor’s Degree in Behavioral Health

Skills Skills

Makes decisions based on knowledge, experience and the ability to forecast using information management and relevant data
Demonstrates understanding of patient care and its issues and represents the nursing profession to others
Ensures that quality support of research laboratory in vivo programs is a team effort between LAR, research staff and other support organizations
Demonstrates the knowledge and skills necessary to provide service/care appropriate to the age of the patients served, in
Demonstrates general working knowledge of computers and department specific software (i.e. Healthstream, internet, etc.)
Self-motivated, able to effectively prioritize in a fast paced environment
Can-do attitude and ability to work collaboratively with internal staff and external partners
Collaborates and fosters positive professional relations with medical staff
Makes work assignments, ensures completion and quality, and administers personnel policies and contract employee agreements
Negotiates adeptly with individuals and groups over roles and resources. Is a team builder; brings people together successfully around tasks

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Analytics Manager, Clinical Analytics Resume Examples & Samples

Experience leading teams engaged in analytics and the development of actionable business insights and/or business solutions; has led others in Analytic or technical roles
Passion for solving problems; Proven ability to draw analytics insights and communicate outcomes effectively to all levels of project and program stakeholders
Experience providing consulting to business units around operational, clinical and/or consumer analytics insights
Master’s degree of Engineering, Informatics, Public Health, Business Administration, Econometrics, Information Technology, Mathematics, Statistics or a related field or equivalent experience
Minimum of 3-5 years planning, managing and delivering complex, large scale, cross-functional projects or programs
Experience using one or more cutting edge technologies and applications in analyzing large, dynamic data sets – examples include, SAS, SQL, R, Qlikview, Tableau, etc
Experience with developing strategic analytics programs
Problem solving utilizing innovative or creative approaches
Experience leading teams engaged in cutting edge analytics of Big Data
5+ years’ experience in Data Science, statistics, predictive modeling, text mining, machine learning or similar advanced analytics capabilities

Senior Manager, Clinical Statistics Resume Examples & Samples

5+ years of experience in molecular diagnostic development
3+ years of experience performing routine and complex statistical analyses
3+ years of experience in molecular diagnostics development
3+ years as a manager of highly-technical teams

Senior IT Manager, Clinical Data Standards Resume Examples & Samples

Develop and maintain a strong view of external capabilities and their ability to drive business value
Create strategy and roadmaps for product lines
Embed agile practices into projects and guide stakeholders on agile methodology and practices
Manage business partner expectations, resolving conflicts
Negotiate the needs of multiple users or business partners
Ensure solutions are consistent with business objectives and strategy
Build and maintain strong partnerships with business and BTL & other PLO organizations
Contribute to the documentation and visual representation of the end-to-end view of process, systems and data flows
Contribute to budget development and monitors budget within area. Optimize application portfolio and operating costs to drive ongoing business value
Bachelor’s degree or equivalent and a minimum of 8 years of relevant experience OR advanced degree and a minimum of 6 years of relevant experience is required
Strong knowledge of Clinical Development processes and technologies is required
Working knowledge of industry standards, vocabularies, data set format such as: CDISC standards (SDTM, ADaM, etc), MedRA is required
Relevant experience in process and technologies to govern and manage master data across complex organizations is required
Ability to relate business priorities to associated technology investments. Ability to recommend priorities based on highest business value based on multiple stakeholders needs is preferred
Knowledge of trends in technology and opportunities in healthcare is required
Successful project delivery experience is required
Broad technology experience with ability to lead assessments of proposed solutions and develop recommendations. Understanding of the business impact of different solutions and ability to assess impact and communicate the tradeoffs between business needs, technology requirements, timelines, costs and risks is required
Understanding of departmental budgets and the ability to allocate resources accordingly is preferred
Thorough understanding of Agile with ability to coach/mentor IT and business partners; Working knowledge of SDLC including requirements elicitation, system design, development and validation/regulatory requirements is preferred
Strong communication and interdependent partnering skills in global setting is required
Three years of staff management and development is preferred.Info Technology

Manager Clinical Forecasting & Analytics Resume Examples & Samples

Bachelor of Science (BSc) or Arts (BA) degree or equivalent degree. (Preference for degree in Health Sciences, Finance, and/or Business Administration)
6 or more years of operational experience in clinical trials within a pharmaceutical company and/or a CRO
In depth knowledge of drug development, global clinical operations, and financial/budget management, specifically financial aspects of conducting clinical trials
Understanding and experience with associated information systems (e.g. SAP, Clinical Trial Management Systems, Planning Systems, Procurement Systems, Investigator Grant benchmarking databases)
Leadership of a team within a matrixed environment
Ability to effectively use Microsoft Excel, Word and Outlook with special emphasis on utilizing Excel spreadsheets to complete business analyses
10%Travel required both domestic and international
Individual must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business
Self-motivated and team-oriented
Ability to see the big picture, well organized, focused on results and customer focused,
Capable of managing multiple projects w/excellent time management and prioritization skills
Experience with tools such as Planisware, Cognos, Beacon, Medidata, Tableau

Manager, Clinical Trials Dcri Resume Examples & Samples

Coordinate the standardization and maintenance of status reports and other information sources
Facilitate communication with external partners and key therapeutic area investigators when issues arise that affect multiple projects and/or Therapeutic Area(s)
Work with project leadership to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues
Assess overall project metrics and study timelines across the assigned Therapeutic Area (s) and assist with the coordination and prioritization of TA team efforts
Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities. Evaluate impact on resource needs, study processes and related documents
Collaborate with clinical operations management and staff to identify current and anticipate long-term staffing resource needs
Collaborate with project leadership to provide project-specific training as needed
Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes as required
Provide input into the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports
Strong personnel management and team leadership skills
Ability to train, coach and evaluate site management and clinical monitoring team members
Ability to direct and manage competing complex individual and team clinical trial activities to meet objectives, timelines and budget
Strong technical knowledge and skills for monitoring procedures and practices
Strong knowledge of clinical research trial operations
Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
Ability to collaborate with team members to achieve trial-specific goals within specified timelines; ability to collaborate with internal and external partners to achieve departmental and organizational goals
Proficient computer skills including MS Office, Word, Excel and PowerPoint, EPM, CTMS, etc.; ability to learn and use computer applications
Ability to independently use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
Strong knowledge of medical terminology
Knowledge of scientific application to clinical trials research
Understanding of departmental SOPs and systems
Ability to travel 25%, some for consecutive nights
Therapeutic Experience (2 years + recent)
Multicenter trial experience (2 years)
Experience managing all phases of a trial life cycle
Experience managing multiple levels of employees
Experience managing multiple number of employees
Experience on commercial and government projects
Regulatory knowledge

Manager, Clinical Services Team Resume Examples & Samples

This position supervises a team of clinicians that will be responsible for care coordination and case management
Responsible for leading a team through coaching, training, motivating and coordinating activities for team members
Ensures the team operates at maximum efficiency
Utilizes data to maximize resource efficiency
Coordinates Choice Time Off management and workload monitoring
Effectively manages projects and implements suggestions for continuous improvement
Supports team by initiating additional training and implementing programs to meet company objectives, as applicable
Builds and leads a strong motivated team by providing guidance, feedback, and day to day direction
Drives performance management through coaching, motivating team members, providing feedback and direction against stated goals, writing and delivering performance evaluations and taking corrective action as necessary to drive individual and/or team performance
Facilitates resolution of Tier 1 and 2 case escalations from team members
May require 50% case load depending on business needs

Manager, Clinical Services Resume Examples & Samples

Serves as a change agent to facilitate communication and transition that supports the mission of the organization
Maintains required program records, reports and statistics for administrative purposes, ensures compliance with established DHCH policies, procedures, objectives, quality control, PI, safety environmental and infection control. Communicates requirements to staff, and holds staff accountable to established requirements
Collaborates with the Director of Business Development to determine fiscal requirements of department and prepare budgetary recommendations. Monitors the level of resources utilized in service delivery and determines the appropriateness of resource consumption
Develops action plans in conjunction with the Director of Business Development to ensure budget and resource efficiency, and satisfaction with patient care delivery
Displays a professional appearance
Gives high priority to client/referral source satisfaction and anticipates client/referral source needs

Manager, Clinical Advisory Services Resume Examples & Samples

Direct Leadership—Provide day-to-day oversight to assigned team of clinical advisors, holding regular one on one and team meetings, and disseminating pertinent company and department information. Hold Advisors accountable for behavior expectations and established metrics, including developing client relationships and engagement, creating and executing account plans, and providing advice that helps their clients improve the patient experience
Provide leadership and professional development coaching to Advisors to elevate their skills in delivering value to clients. Actively seek to challenge high-performance Advisors with more challenging assignments
Client Retention and Engagement—Ensure client retention and satisfaction by developing and executing client retention and engagement strategies (consistently but customized to the client), acting as the primary problem solver, and knowledge resource for the team, and working cross-functionally with leaders and associates supporting clients
Collaboration Across the organization for innovation, product development, and Client Engagement Services to assure that the voice of the client is being heard and the client is at the center of our care—Will serve on a variety of team or focused project committees and serve as a major contributor
Education, Sales, Marketing, Planning, Product, etc. Will work to integrate clinical team advisory services and assist partnership planning templates and measures of performance for our clients
Department and Team Operations-Contribute and adhere to an annual budget, departmental plan, department projects, and appropriate staffing plans
6-8 years of experience required

Manager, Clinical Programs Resume Examples & Samples

Provide support to the team including coaching, mentoring on technical matters pertaining to medical information, compliance support, case coordination, drug reimbursement, financial assistance
Manage team of Medical Information Specialists and Adherence Nurses
Management of employee performance within McKesson policy and procedures
Create staffing plans with the support of the Director, Operations
Create and monitor operational metrics to ensure that operational deliverables meet the standards of McKesson and the client
Work with the Senior Manager, Clinical Patient Services, to develop and implement departmental objectives
Accountable for the creation and maintenance of training records, work instructions, for operational activities related to McKesson Specialty Medical Information Programs
Identify and implement opportunities to improve operational efficiency and quality
Work collaboratively with patient services and pharmacy management to optimize the integration of services supported by McKesson
Work collaboratively with program management and account management teams to develop and implement solutions that address clients and McKesson business objectives
Work collaboratively and supportively with all members of the Operations group
Perform duties in compliance with all relevant company standard operating procedures (SOP) and policies, regulations and client SOPs when applicable
Maintain appropriate communications with all levels of the organization
Track/record and submit time spent on projects and other activities
Always keep work area safe, organized and clean
Account and client relations preferred
Experience managing a remote workforce
Average to advanced proficiency with Microsoft Office software
Familiarity with drug reimbursement in Canada
Health Care Professional (Nursing, Pharmacy, Physician)
Call Centre/Contact Centre experience preferred
Bilingual, an asset

Senior Manager, Clinical Analytics Resume Examples & Samples

Accountable for the management, triage, and quality assurance of ad-hoc clinical analytics requests including the management of clinical business advisors / analysts performing client analytics
Project management of team / departmental initiatives including the supervision of enhanced analytics projects to facilitate quarterly plan performance review analytics, Strategic Account Review evaluations, client insights, and comprehensive trend management and utilization forecasting
Management of strategies and interfacing with clinical consultants and account management teams to drive comprehensive client analytics, recommendation of clinical program solutions, identification of cost drivers, evaluation of clinical outcomes, and communication of program solutions and product upsell opportunities
Responsible for ad hoc client analytics including clinical program analysis / modeling as well as development and maintenance of analytical reporting that contains insightful, action-oriented information
Support the initiation, development and implementation of solutions for enhanced clinical analytics including clinical model development, clinical outcome solutions, cost driver analysis and other clinical analytics/predictive modeling
Interface and serve as liaison with other internal teams including Product Development, Outcomes Research, and other teams to provide analytical insights applicable to current program management as well as future program development
Lead team meetings and on-going employee engagement, development and training initiatives
Performance of duties as required by Director and departmental needs
5 years of relevant work experience leveraging pharmacy and or medical administrative claims data in a managed care or pharmacy benefits management setting
Expert level of proficiency in MS Office tools specifically Excel and or Access
3+ years of progressive leadership experience with direct report/staff management responsibility
SAS experience
Excellent leadership as well as written and verbal communication skills are needed, including the ability to translate analytic concepts, approaches and results for executive or lay audiences, and analytic interpersonal skills with an ability to communicate to small and / or large audiences (both internal and external clients)
Experience in communicating to a senior management audience and ability to drive consensus on complex, controversial issues
Strong commitment to customer service and ability to work collaboratively across multi-disciplinary teams

Program Manager, Clinical & Quality Solutions Resume Examples & Samples

Manage client priorities and coordinate internally with various stakeholders to successfully manage HEDIS/Stars projects on behalf of clients
Understand payer challenges and basic concepts of CMS Quality Programs
Demonstrates ability to consistently follow published HEDIS and Stars technical specifications and manage annual and ongoing HEDIS projects
Analyze, review, forecast, and trend complex data
Function as the first point of contact for all client questions (e.g. provide primary software support for clients)
Provide software training to clients
Thorough understanding of measure analytics to perform investigative research
Manage customer expectations, and provide critical feedback to software development personnel
Directs / provides enhancements to business processes, policies and infrastructure to improve operational efficiency across the organization
Take a leading role in assisting the QI leadership in the evaluation of patterns and trends related to HEDIS, CAHPS, HOS data
Provide strategic support in the development of member/provider incentive programs
3+ years of experience with data analysis in a health care delivery organization, such as a managed care organization
3+ years of CMS Stars and/or HEDIS experience, performing a wide range of functions with strong focus on data analysis
3+ years of process improvement and/or project management experience
3+ years of experience gathering and documenting requirements from clients
Intermediate level of proficiency with MS Excel and PowerPoint
Experience with claims and claims processing
Knowledge of Medicaid and/or Medicare programs
Knowledgeable of current trends in HEDIS in managed health care
Knowledgeable of NCQA, CMS, HEDIS, HOS and CAHPS requirements
Ability to work with and be comfortable with ambiguity
Ability to manage and prioritize large, highly-visible projects
Ability to communicate analysis including trends and opportunities to clients in writing and verbally
Intermediate level of proficiency with MS Access

Manager, Clinical Process Quality Resume Examples & Samples

Provides day-to-day oversight of Quality Analysts and Medical Coding Coordinators for the DataRAP® department to ensure DataRAP® processing is completed timely and accurately
Develops quality audit program to ensure quality of medical record reviews are performed accurately and consistently by each reviewer
Works with the Chief Education Development Officer to ensure training for providers is consistent and accurate
Develops, in partnership with DataRAP® leaders, policies and procedures, process metrics, data collection tools, and presentations of resultant data as it relates to risk, change control, and policy and procedure issues throughout the entire DataRAP® process
Coordinates HEDIS activities as required by Physicians Health Choice as well as coordinates HEDIS reviews with Director of Clinical Data Operations
Ensures continuous improvement in the development and implementation of DataRAP® medical record review processes and resource tools
Manages the continued implementation of DataRAP® application and quality upgrades to DataRAP® applications
Continually develops and implements quality improvement initiatives to maintain compliance with CMS and ICD-9 coding requirements
Responsible for monthly reporting and tracking of medical record chart reviews and return audit process for all markets assigned
Manages and assists with the development of the department budget by controlling expenses indicated within the budget plan, and provides justification for expenditures outside of budget plan
Oversees and coordinates preparation activities for CMS and/or health plan audits. Performs mock CMS audit to ensure readiness in event of CMS audit. Prepares and serves as the department representative for the interview/audit process with CMS and / or health plan auditors
Verifies, reviews, and communicates audit results and reports and institutes corrective action / follow-up
Works with IS to provide nurse productivity reports and analysis to senior leaders. Informs and educates the DataRAP® team on return audit workflow and operations
Selects and uses a wide variety of quality and auditing tools and techniques in practical applications to evaluate the effectiveness of the quality program
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements
Establishes performance improvement teams as necessary to address any issues identified
Ensures adequate staffing is in place to meet market demands. Manages the staffing FTEs within budgeted guidelines. Provides employee coaching, counseling, and annual performance reviews
Education Bachelor’s degree in Nursing, or Associate’s degree in Nursing combined with four or more years of experience
Current, unrestricted RN license required, specific to the state of employment
Five or more years of RN-level clinical nursing experience
Three or more years of management-level experience in a clinical setting
CPC certification or ability to obtain one within nine months from the American Academy of Professional Coders
Demonstrated leadership ability to manage and direct various levels of staff
Ability to effectively manage projects, plan and implement programs and evaluate accomplishments
Ability to effectively report data, facts and recommendations in oral and / or written form
Ability to analyze facts and exercise sound judgment, arriving at proper conclusions
Ability for adaptability and flexibility
Strong analytical, problem solving, time management and attention to detail skills
Goal directed, results oriented and change management attributes
Bachelor of Science in Nursing (BSN) or other related Bachelor’s degree
Certification as an RN coder or actively pursuing certification
Process/Quality improvement experience

Business Manager, Clinical Service Lines Resume Examples & Samples

Minimum five (5) years of experience in consulting, operations or project management ideally in a health care setting preferred. Minimum three (3) years of management experience preferred
Experience with business process improvement and the tools and data requirements for supporting an effective business process improvement project
Demonstrated experience developing and implementing key strategic initiatives and project management required
Must have proven experience in managing multiple projects and priorities of a complex nature
Demonstrated ability to structure, drive and execute complex multi-disciplinary issues to closure with minimal direction
Demonstrated ability to lead professionals and manage others through influence and collaboration
Expert knowledge (broad expertise or unique knowledge) of health care policies, practices and systems
Knowledge of health care operations/ health care delivery, project management, and quality improvement is required
Working knowledge of Lean principles and process improvement desired
Expert proficiency in spreadsheets using pivot tables, formulas and graphics
Work requires advanced interpersonal skills necessary to direct the work activities of multiple departments, provide motivational direction and guidance to management who are not direct subordinates but who work in the Clinical Service Lines
Demonstrated ability to determine key business issues and develop appropriate action plans from multidisciplinary perspectives
Demonstrated performance in strategic/operational analysis and planning, analytical techniques, financial and market assessments
Proven leadership skills in project management and consulting. Must exhibit efficiency, collaboration, candor, openness, and results orientation
Superior communication, facilitation, negotiation, conflict management, problem resolution, change management and consensus building skills
Proven ability to effectively manage in ambiguous situations with minimal direction
Proficient in team building, project management, and budget management
Excellent interpersonal skills (written, oral, and presentation)
Must be detail oriented and self directed - able to work effectively in a team environment and independently
Results driven in order to drive quantifiable initiative success throughout Sutter Health
Must demonstrate the ability to cultivate a strong network within Sutter Health
Must be skilled in keeping others focused on the end goal – improving quality of patient care

Associate Manager, Clinical Development Resume Examples & Samples

Ensure high quality data and rigorous scientific analysis of clinical studies and provide input timely preparations of scientific papers and publications
Assist with designing early stage clinical studies, develop analysis strategy, and assess results of FIH programs
Maintain regular contact with Marketing, Clinical affairs, and R&D organizations for the exchange of study related information and its impact on project strategy

Manager, Clinical Outsourcing Resume Examples & Samples

Science background BS or healthcare degree or diploma preferred
Experience in clinical or pharmaceutical/biotech or academic setting
Experience contract negotiations
Knowledge of Physician Financial Transparency Reports (Sunshine Act)
Ability to work to work across multiple functions
Ability to review complex and disparate data in a clear and concise manner
Ability to learn and work autonomously
Excellent interpersonal, organizational and multi-tasking skills
Ability to interface with outside counsel, vendors, collaborators, all internal departments and all levels of management

Manager, Clinical Study Resume Examples & Samples

Supervise clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs
Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished
Participate in forecasting study expenditures and resourcing needs
Establish communication flow with CRO and investigative sites to maximize compliance with study protocol
Manage recruitment efforts and activities to meet study enrollment goals and timelines
12+ years of experience in the pharmaceutical/biotechnology industry
Experience in management of international or global clinical trials is preferred
Experience in protocol development/writing
Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I- IV, start-up through close-out), scientific methods, research design, regulatory compliance, and clinical data management
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members
Ability to travel up to 25% travel including ground and air required

Global Manager, Clinical Site Services Resume Examples & Samples

Excellent verbal and written communication skills. Analytical skills and the ability to carry projects to successful completion. Strong multitasking abilities
Leadership Skills, ability to oversee operations teams across different studies and therapeutic areas
Strong multitasking abilities
Self-motivated with ability to work with minimal supervision, with aggressive deadlines
5+ years of experience with clinical investigator sites participating in clinical trials
Exposure to study coordinator roles and responsibilities
Experience with medical imaging preferred

Manager, Clinical Data Standards Resume Examples & Samples

Operational Support for Implementation of Celgene Data Standards
Develop and maintain project data standards, considering the needs of individual studies within the project, while following Celgene global data standards. Make decisions in conjunction with Global Standards Manager(s) regarding when project data standards can and should deviate from Celgene global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models
Provide input into individual study deliverables with data standards components, including
CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project
CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
Programmed edit checks, to ensure consistency across the studies within a project
Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project
Work with standards management systems and software, such as a Metadata Repository, OpenCDISC, and issues tracking systems
Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from software tools such as OpenCDISC and Celgene custom validation programs
Communicate and reinforce content and interpretation of Celgene data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project
Act as the key point of contact for project specific standards implementation issues
Provide input into project and study timelines and vendor contractual agreements
Participate in project and study team meetings as needed, specifically in a supportive capacity
Standards Support for Submissions
Provide guidance to Submission Team regarding overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used
Work with the Submission Team to prepare pre-NDA correspondence on submission datasets
Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files)
Act as a consulting resource for study teams regarding the validation of eCRT/define packages
Represent CDSI group on the submission team
Other Key Activities
Assist with development of department or cross-functional processes and best practices
May coach junior personnel or manage contract staff, as required
Lead or participate in special projects as assigned
Propose solutions and share best practices with project and study teams, and within DOP as required
BA/BS in a relevant health science or computer science discipline; minimum experience: 7 years as a programmer, data manager, or standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience
Strong working knowledge of the Study Data Tabulation Model and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml
Strong project management and negotiation skills
Ability to work effectively with minimal supervision in a cross-functional team environment, across Celgene departments, and with external vendors
Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus. Experience with a Metadata Repository or other related standards management system is preferred
Experience in CRF design, query resolution, and data validation
Good communication skills; ability to work in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians
Experience with regulatory submissions or working with submission teams is preferred

Manager, Clinical Process Development Resume Examples & Samples

Drive the development, review and continuous improvement of new/revised clinical SOPs, including identifying and working with the author and subject matter experts to define the process and coordinate the clinical steering committee review
Support clinical staff in the development of work instructions and/or other procedural tools, as necessary
Coordinate Global Clinical Operations Steering Committee review of new/revised SOPs, work instructions and other procedural tools
Liaise with Quality Assurance to ensure that clinical SOPs are approved, updated, stored, etc. according to company SOP requirements
Develop and implement communications to ensure clinical staff members are appropriately informed of Sharepoint, Process Optimization updates
Manage SOP/WI workflows and timelines for Global Specialty Development (eg GCO, BM)
Participate in Global Process Optimization initiative with key stakeholders throughout the organization and partner CROs
Manage Procedures and Training SharePoint site including design, updates, notifications, and improve ease of use for end users
Supports the design and implementation of training courses
Interfaces with CROs for SOP/WI and training requirements, including gap analysis and operational manual/process improvements
Lead or conduct other projects/tasks as requested
Bachelor degree in science, with preference in a healthcare field, or equivalent is required
3 – 5 years in pharmaceutical industry experience with at least 2-3 years experience in an SOP/process, training, or clinical position
Demonstrated success in facilitating, communicating and implementing process design and/or improvement initiatives is a must
Good working knowledge of GxP and demonstrated skill in effective written and oral communication, collaboration/negotiation skills and proven record of being an effective team player are required
Relevant experience in instructional design, education, training or equivalent expertise is strongly desired

Manager, Clinical Trials Resume Examples & Samples

Manages/oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements
Assist with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones
Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports and reviews and approves monitoring reports as appropriate. Reviews CRO site monitoring calendars, tracks site visits, tracks monitoring report issuance and receipt, conducts initial reviews of reports, to assure that full internal reviews are conducted on a timely basis
Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of annual reports, IB updates
Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies
Participates in special projects as appropriate
Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues
Acts on constructive feedback by using feedback from peers, supervisors, and colleagues to improve performance

Manager, Clinical Development Resume Examples & Samples

Reviews clinical study documentation submitted by Sandoz Business Partners for GCP as well as regulatory compliance as part of due diligence and co-development processes
Responsible for the Clinical Information Management System for study scheduling, status re-porting and any required safety reporting
Coordinates Bio study Sample shipments to CRO’s with document preparation and regulatory requirements for sample shipment
Coordinates activities required for obtaining CTA or T-License approvals for studies run abroad
Participate in updating and review of existing Standard Operating Procedures and Clinical Trial Procedures
2 years or more FDA clinical review experience preferred

Manager Clinical Evaluation Resume Examples & Samples

Writing clinical evaluation plans and reports according to the MEDDEV 2.7.1 guideline
Working cross-functionally with Product Development, Regulatory Affairs, Product Management, Launch Team and Marketing on pipeline projects
Supporting other departments with clinical content and knowledge

Manager, Clinical Quality Resume Examples & Samples

Prior experience in quality assurance; global experience preferred
Strong understanding of regulations and guidelines related to quality systems and documentation
Strong attention to detail and ability to resolve issues collaboratively
Ability to interact across multiple functional areas, as well as countries, with keen attention to cultural differences
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute
Asks question to better understand the rationale for and benefits of change
Maintains optimism and composure in times of change, uncertainty, or stress
Deals constructively with mistakes and setbacks
Maintains a high level of performance in the face of ambiguity or change
Responds openly to feedback viewing suggestions as learning opportunities

Manager, Clinical Supplies Resume Examples & Samples

Bachelor’s degree in a science or logistics field or equivalent number of year’s experience in the Clinical Supply sector
4-6 years of direct line management experience
Clinical Supplies specific training and courses
Detailed cGMP, GCP and ICT knowledge
Expert knowledge of GMP’s and GCP’s

Manager, Clinical GDN, Grades Resume Examples & Samples

Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning,
Assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct on boarding training for new staff in conjunction with Human Resources and Global Talent training programs
Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review and mentored training experiences, as applicable
Participate in the allocation of resources to projects by assigning staff to studies that are appropriate to their experience and training
Manage the quality of assigned staff's work through regular review and evaluation of work product
Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by Management
Assist in ensuring consistent standardized processes are implemented and department deliverables meet expected quality, financial and productivity targets
Ensure timely movement of project work through the process steps, in accordance with governing Standard operating Procedures (SOP) and working instructions
Develop specialist expertise in aligned specialist areas, as well as applying them across various functions
Prepare presentation materials for department meetings
Works constructively in a matrix framework to achieve project and internal stakeholder deliverables. Actively contribute to initiatives and work in close collaboration with Operations team
Participate in Department quality and/ or process initiatives
Mentor Leads/ Associate Managers as assigned
Assist in meeting department financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions
In-depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Basic therapeutic and protocol knowledge
Good leadership skills
Strong mentoring skills
Bachelor's degree in life sciences or related field and 7 years relevant experience; or equivalent combination of education, training and experience

Senior Manager, Clinical Trials Resume Examples & Samples

Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines
Keeps management informed by escalating issues requiring intervention to the study and project teams under the supervision of the Associate Director/Director
Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues
Bachelor's degree from a four-year university or college; and 7 to 10 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, including GCP
Ability to manage complex and global clinical trials
Ability to effectively present information to and respond to questions from groups of managers, sites, etc
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists
Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel

Program Manager, Clinical & Operational Resume Examples & Samples

Ensures detail project plans have agreed timelines, critical milestones and interdependencies are defined, and communication checkpoints occur and risk are mitigated
Proactively identifies and communicates specific issues, risks and conflicts to appropriate stakeholders
Communicates portfolio health and risks
Plans and conducts readiness assessment and milestone reviews including managing and reporting project expense anticipating overrun(s)
Ensures all initiatives within portfolio adhere to companies Solution Development Process
Create and maintain visibility of overall value and health of the portfolio and specific product(s)/project(s) under consideration, underway and implemented
Determine and analyze resource capacity levels across initiatives within the portfolio
Work with product leaders and delivery teams to define and create success measures that are realistic, achievable and implementable; track these measures through ongoing performance assessments
Bachelor’s degree preferred. Master’s degree in business and/or healthcare administration desired
5 + years program or project management experience with a proven track record of successfully managing complex programs and projects
Experience in B2B healthcare technology or services are preferred. Demonstrable knowledge of Agile development methodologies is preferred
Able to proactively lead cross-functional work teams through influence to define project plans, identify dependencies, create milestones and document risks
Must possess strong facilitation, communication, influence negotiation skills in order to drive a vision and lead work stream team members towards the accomplishment of program/project goals
Strong communication skills with ability to develop artifacts that accurately convey actionable information about key project measures
Flexibility to work with ambiguity and changing priorities
Adept at managing project plans through strategic partnerships across the organization
Effectively implement best practices in product, project and change management
Project Management Professional) certification is preferred

Manager, Clinical Rehab Liaison Resume Examples & Samples

Coordinates the assignment of CRS to assure coverage of the market. Effectively moves CRS to assure prompt response times to hospitals with a high number of referrals on particular days. Coordinates physician and case management marketing opportunities for the market. Completes face-to-face, in-service educational contacts with physicians, case managers, other interdisciplinary members and other professionals. Serves as an educational resource to patients, family members and caregivers
Coordinates the intake process to assure all benefit verifications and insurance authorizations are completed. Assures fair and equitable assignment of patients between rehab programs with consideration given to geography, patient choice, specific needs of the patients, census considerations, and the 60% Rule status of each program. Effectively collaborates with Program Directors at each site. Performs on-site and off-site clinical evaluation to assist Rehab Medical Director in determining appropriateness of patient for admission
Advises referral sources on inpatient rehab criteria. Ensures all referral sources receive appropriate and timely follow-up communications regarding their patients and hospital programs
Assists Rehab administration in the development of a SWOT analysis and strategic plan. Identifies opportunities where admissions are challenging to attain, and develops a strategy and a working plan to grow admission volume in those places, including analysis and communication about potential qualifying patients being lost to competitor IRF or SNFs in the community
Required: Licensed Professional in a clinical health care specialty with current state licensure in clinical practice area or eligible for state license transfer

Manager, Clinical Trials Operations Resume Examples & Samples

2+ years of observational research experience
Pediatric research experience
Background in Public Health

Associate Manager, Clinical Trials / Study Resume Examples & Samples

Support in the management of all aspects of clinical research program(s) and/or non-interventional study program(s)
Adjusts priorities and demonstrates adaptability, identifies and implements new or different ways to achieve goals
Identifies, analyzes, and communicates problems, issues, and opportunities. Develops and implements effective solutions to achieve desired outcomes
Lead Registry process improvement initiatives
Completes assigned tasks within functional team
Assist with any special projects as assigned
Expected to provide valuable input on plans & decisions
Evaluates and manages time and resources effectively
Provide mentorship within functional team
Knowledge of the drug development process in the planning and management of clinical studies
Develops and delivers information in a clear and concise manner within company and clinical research guidelines
Listens actively and shares relevant information with others
Develops effective working relationships with business partners to achieve business goals
Demonstrates an understanding of clinical research processes and industry competition
Understands the disease state and treatment options
Develops project plans and manages multiple projects to achieve goals within established timelines
Ability to create and deliver a presentation
Collaborates to identify strengths and developmental areas; creates, owns, and implements professional development plan
Responsible for implementing plans & decisions in collaboration with Study Manager
Ability to work collaboratively, effectively, and productively in diverse organization structures
Team player and ability to build relationships
Ability to demonstrate leadership capabilities
Solid computer skills and practical knowledge of MS Word, Excel, PowerPoint and project management software
Knowledge of clinical research databases, especially EDC
Ability to create and deliver presentations to management or team members
Must be flexible and manage change easily
Ability to work positively within a continually changing environment
Ability to effectively prioritize and execute tasks in a high-pressure environment
Familiarity with ICH / GCP and regulatory guidelines/directives
Knowledge of medical/scientific terminology
Completed BA/BS in directly-relevant discipline or equivalent experience required
8 to 10 years of experience in the pharmaceutical, CRO, or healthcare environment(s) required
Knowledge of drug development process, FDA, ICH, and GCP guidelines
Oncology experience is strongly preferred
Experience working with non-interventional study program(s) is strongly preferred

Associate Manager Clinical Trial Mgmt Resume Examples & Samples

Participates in cross-functional study team (s) and/or sub-team(s)
Assists with building, managing, and maintenance of budgets, contracts and timelines for a given clinical trial
Prepares content for training materials and coordinates training on study procedures
In collaboration with medical director for study, may create study plans and study specific working practices
Helps establish study team contacts, roles, responsibilities, and objectives
Develops, manages, and maintains relationships with external partners
Assists with development of study execution plans and risk management plans
Facilitates effective communication between study sites and study team members to ensure ongoing successful execution as required
Provides ongoing mentoring and guidance to CRA’s/CTAs as assigned

Manager Clinical Audit Resume Examples & Samples

Provides supervisory oversight of the auditors on the Clinical Audits Department, national team
Meets with auditors on national team on monthly
Coordinates new auditor training for national team
Complete annual reviews of assigned auditors
Will conduct initial interviews of any new open positions for the national team
Tracks the status of all assigned audits (all requested, re-credentialing, and quality of care audits) for entire Clinical Audits Team and reports status to Senior Manager
Communicates with Credentialing Department lead and appropriate network management/contracting in situations where there are issues with completing re-credentialing audits and logs updates
Complete ongoing reviews of audit assignments of all types (credentialing, re-credentialing, and quality), identifying audit assignments that are delayed, and discussing with auditors when there are audits at risk of not being completed with expected turnaround times
Review and assign all quality of care audit requests
Oversee training of new auditors related to quality of care audits
Review quality of care reports written by auditors for completeness and clarity
Presentation of Quality of Care audit results for
National Peer Review Committee
Sentinel Events Committee
Medica Quality of Care Committee
Provide oversight of receipt of Corrective Action Plans with the auditor
Licensed Master's degree - level clinician in Psychology, Social Work, Counseling or Marriage or Family Counseling OR a Licensed Ph.D. level Psychologist
License must be independent and must be active and unrestricted
2 +years of experience in behavioral health
Strong computer proficiency with Word, Outlook, and Internet
Quality improvement knowledge
Experience in managed care
Hospital and Outpatient experience
Background working as an Auditor, including chart audit experience

Manager Clinical Medical Management Resume Examples & Samples

Manages and is accountable for professional employees and / or supervisors
Supervise the day to day operations of the department - including direct supervision of the field case management team overseeing the skilled nursing case managers and team
Help to achieve Medical Management targets of: bed day reduction, readmission rates and post discharge outreach
Oversight of internal audit to insure compliance and effectiveness of programs
Trouble shoot clinical issues involving patients and providers in the Utah market
Assist in clinical direction for the clinical teams in Utah involving skilled nursing, acute inpatient rehab, long term acute care, home health and palliative care
Help prioritize and facilitate pilot programs for clinical success in the Utah market
Insure MCG criteria is meet for clinical determinations
Organize and prioritize clinical meetings involving patient centered care
Active RN license in the state of UT
3+ years experience providing direct patient care - with an emphasis on skilled nursing
3+ years of clinical leadership experience involving direct reports from a clinical team
5 years supervisory experience in managed care or skilled nursing
Case management in skilled nursing or equivalent for 2+ years
Understanding of long term acute care, acute inpatient rehab, home health, palliative and acute inpatient qualifications
Utilization management and discharge planning experience
Understanding of Medicare criteria and guidelines
Understanding of Medicaid long term care qualifications
Ability to work within our core values, integrity, compassion, performance, innovation and relationships
Ability to adapt to an ever changing and growing environment with a positive attitude and a willingness to embrace change

Manager Clinical Supplies Associate Resume Examples & Samples

Qualified candidates will have a Bachelors in Pharmacy or related field-MS or PharmD a plus
Minimum 5 years of related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination
Demonstrated experience in global inventory management, forecasting global drug supply needs, global distribution of clinical supplies, use of IXRS systems to assist in drug supply forecasting and site supply management, and contributing to budget control
Must have ability to effectively communicate and influence others to accomplish clinical supply goals and objectives
Must have strong problem-solving skills
Experience in managing third-party contract clinical supply operations required
Strong knowledge of clinical supply planning, manufacturing, packaging, and labeling
Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
Experience managing biopharmaceuticals and small molecules and a variety of dosage forms (sterile injectables, capsules, tablets) and packaging configurations
Thorough understanding of pharmaceutical development, Quality Assurance, and Regulatory (domestic and international)
Strong knowledge of cGMPs and GCPs for drug products
Organize all activities involved with the management of clinical supplies
Proactively and strategically manage the forecasting, procurement, packaging, labeling, distribution, return, reconciliation, and destruction activities of investigational products and ancillary items (i.e., labeling components)
Work with both internal and external customers and suppliers to develop and communicate clinical supply strategy (including project budgets and timelines) and to ensure that all project objectives are met in a timely and compliant manner
Collaborate with clinical teams to forecast global demand and identify appropriate inventory levels; distribute monthly inventory and distribution reports
Facilitate the development, negotiation, and approval of formal quotes/work orders/proposals
Confirm production plans and shipping schedules; develop depot/site resupply strategies and coordinate packaging schedules with third-party provider(s) to support clinical demand changes, i.e., change in distribution timelines for new studies, enrollment changes, additional sites, etc
Track the import and customs clearance of bulk and labeled clinical supplies to depots
Work with third-party providers to develop detailed project plans and timelines for the packaging, release, and distribution of clinical supplies
Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records, etc.); maintain electronic and paper files
Manage the performance of third-party providers to ensure the efficient, high quality, cost effective execution of outsourced clinical supply activities
Contribute to CMC content of pharmacy manuals
Coordinate the design, internal review and approval, and translation of labels to meet regulatory needs and comply with US and foreign regulations, as appropriate
Plan and oversee the implementation of expiry date extensions
Coordinate the assessment of and track temperature excursions during storage, receipt, or transit to clinical sites or depots
Support the transportation and disposition of returned/unused materials, as needed
Provide support to source comparators and placebos
Recommend appropriate blinding strategies
Evaluate emerging trends, technologies, and best practices and provide recommendations. Identify opportunities for efficiencies and expedited performance
Support the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, disposition of returned/unused materials, etc

Senior Manager, Clinical Systems Resume Examples & Samples

Is responsible for the delivery of CPMO’s systems projects
Is responsible for ensuring day-to-day support needs meet business expectations
Ensures consistent and compliant support of systems
Partners with CPMO Management to ensure business needs are met on-time and with quality
Provides leadership and subject matter expertise on projects
Partners with vendors in keeping abreast of technology trends and applicability to business needs
Contributes to the CDRA Systems Strategy and Governance
Works collaboratively with Corporate IT in the management of enterprise systems, the development and adherence to standards and governance, enterprise architecture and common infrastructure
Understands Regulatory business domain and/or technology very well, and is able to analyze business challenges and present technology solutions
Excellent and hands-on experience in technologies such as Veeva, SharePoint, CTMS, IVRS, and off-the-shelf software that supports the Clinical Operations
Has strong experience in SDLC methodologies and CFR Part 11 compliance
Responsible for all Functional Systems SOPs, compliance and workflows, and Deviations and CAPA
Participates in the development, modification and implementation of company practices, and policies
Responsible for career development for CDRA Systems organization supporting one or more business function(s)

Associate Manager, Clinical Affairs Resume Examples & Samples

Work with project teams to develop clinical study strategies, understand patient population and customer requirements
Lead cross functional meetings to develop and establish project schedules
Develop and/or review study protocols, reports, and other materials
Develop and/or review clinical SOPs
Create and implement regular process improvements
Work with external vendors, as needed to meet business objectives
Implement training strategies ensure site compliance of clinical studies, in alignment with clinical protocol and applicable regulations
Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships
Work independently to manage all clinical tasks and deliverables to meet clinical timelines
Maintain current knowledge of clinical regulations and standards (including changing regulations)
Bachelor's degree, in a related biological or life science discipline or nursing degree is required
Clinical research experience, 5-7 years
Previous project management experience preferred
Ability to work independently and as an active member and leader of a team
Ability to address delicate situations and effectively manage conflict
Ability to lead and motivate others to action
Must be able interact with high profile investigators in a positive and constructive manner
Knowledge base of medical device regulations, domestic and international

Senior Manager, Clinical Market Engagement Resume Examples & Samples

Partnering with Business Line and Functional leaders and supervisor in the execution of strategic plans for product launch platforms that clearly articulate the value proposition and are aligned and measurable to business goals - ensuring those plans execute on strategy, on time and on budget
Acting as steward of the 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
Driving development and distribution of relevant marketing and communications pieces by maximizing planning and synergies across inVentiv Health ensuring connectivity to the organization's global business goals to achieve a competitive edge in the marketplace
Overseeing production of multimedia content pieces such as podcasts, videos and webinars and collaborating with internal partners including Commercial experts on synergistic activities
Engaging clients and BD targets through strategic activities at conferences and other events, designed to showcase Clinical products and services including (but not limited to) abstract development, relationship management, panel recruitment, discussion guide development, on-site support (photography/recording), post-conference reporting
Supporting the execution of Clinical Executive Visibility activities, award applications and publicity
Rolling out enterprise initiatives and their pull-through for Clinical leaders, e.g. social media channel strategies and execution for amplification of content
Researching competitor landscape to identify opportunities to differentiate inVentiv Health thought leadership and drive market share of voice that supports the prioritized Business Line objectives
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
Maintaining a comprehensive communications calendar representing all Clinical activities within the master calendar the GCC&M team maintains
Bachelor's degree required. Business and/or Healthcare media experience a plus
Must have a minimum of 8-10 successful years of experience in public relations, corporate communications or marketing in healthcare, with 2-3 years' experience with a CRO strongly preferred
Collaborates effectively with communications professionals across the business units to apply best practices to all communications
Ability to work in a fast-paced, deadline driven environment
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 PowerPoint presentations
Ability to distill complex language from a variety of sources into effective, easy-to-understand, concise messages for a variety of internal and external audiences
Highly developed analytical skills and an ability to solve complex problems
The drive for self-development, the ability to collaborate, and an action-oriented work ethic

Manager, Clinical Services & Analytics Resume Examples & Samples

Takes a key role in the execution of developing complex data models and advanced reporting deliverables leveraging data across the enterprise. Can work and execute independently as well as collaboratively within the team
Partners with Account Management and Clinical teams to communicate the value of Argus products through analysis and presentation of the customer's data, reports and other analytics
Commercializes customer facing Predictive Analytics, Trend and Insights Consultative Analytics through requirements, methodology and standardization
Acts as customer advocate, rigorously understanding their unique requirements, in the development and delivery of clinical, financial operational value based analytics solution
Identify and incorporate current industry-specific and book of business metrics into analytics to highlight relevant trends and support fact-based recommendations and decisions
Assist and train internal account and clinical teams on how to effectively access and use analytics. Communicate key messages, risks, and opportunities in financial, clinical and operational information to leadership
Analyzes data, identify patterns and recognize trends using financial and statistical programs
Strong attention to detail in producing, cross-checking, and validating data products to ensure its accuracy; ability to verify data accuracy from feeder systems as well all internal and external reporting and analytics deliverables
Prior experience in coordinating reporting/analytics projects involving multiple staff members within work group and/or cross-functional teams
Collaborates with IT to improve the quality of analytics and reporting processes according to internal and customer requirements
Keeps abreast of new analytics tools and methodologies for possible deployment. Aware of business trends, macro/micro economic factors and socio-demographic changes
Understand Argus’ vision and strategy (long- and short-term) and how they translate into analytic approaches
Strong proficiency with computers and MS Office Products
Intermediate to advanced working knowledge of Microsoft Suite including Access and Excel

Senior Manager, Clinical Development Resume Examples & Samples

Responsible for the day to day management of assigned clinical studies including but not limited to investigator selection, analysis and establishment of enrollment strategies, and preparation of study-related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements)
Develop project timelines (utilizing Microsoft Project software), study budgets and project management plans. Report project status to senior management
Participate on product development core teams as the clinical representative for assigned projects
Writes and/or reviews clinical study protocols and ensures compliance with applicable regulations
Leads clinical sub-teams and reports sub-team activities to core team
Works with business development to identify and select consultants, vendors, contract research organizations (CROs), etc
Responsible for overall management of vendors/CROs to ensure project success
Ensures adequate monitoring of study is conducted by clinical sub-team/CROs
Responsible for the oversight of the ongoing maintenance of the Trial Master File
Manages multiple clinical studies in parallel, through direct reports and/or other support staff, as appropriate
Performs personnel related supervisory duties as applicable, including selection, development, and performance evaluation of personnel to ensure the efficient operation of the team
Monitors compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities
Reviews all unanticipated adverse device effects (UADEs), ensures medical review and reporting requirements are met, and that all company procedures are complied with
Compiles reviews and concludes device complaints; ensures corrective action is taken as needed
Writes and/or reviews clinical sections of regulatory submissions and product labeling and ensures compliance with applicable regulations
Reviews, assesses and interprets data from ongoing and completed studies, and prepares reports as required
Writes abstracts, papers, and manuscripts related to study results as required
Creates and implements departmental procedures (including project management processes and SOPs) in compliance with industry standards and regulatory requirements
May provide input and support for post-clinical activities and market launch of product
May participate in organizational initiatives
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities

Manager, Clinical Services Resume Examples & Samples

Hire Clinical Team staff including tobacco quit coaches and enrollment personnel
With support, from the Assistant Manager of Clinical Services, manage the Clinical Team of 15-17 coaches and enrollment personnel
With support, of lead faculty for Training and New Initiatives, oversee training for the Clinical Team
With the Assistant Manager for Clinical Services, manage the day-to-day operations of the Clinical Team
Actively participate in ASHline Management Team
Guide the Assistant Manager of Clinical Services in schedule management for services coverage
Work with the Community Development Team Manager to coordinate efforts related to the proactive fax referral program
There may be additional duties assigned as it relates to this position
Master’s Degree in Public Health, Counseling, Social Work or Health related field
Experience in supervision of staff providing direct counseling, coaching or public health services
Three or more years’ experience working with clients in a clinical setting
Prior experience in personnel management with evidence of strong leadership skills
L.M.S.W. or L.C.S.W
Working knowledge of Motivational Interviewing, preferably specific to tobacco cessation
At least two years’ experience with clients with mental illnesses
Experience with clinical documentation and confidentiality
Experience in program development and strategic planning
Previous experience in publicly funded community program management
Experience with multimodal behavior based software to deliver coaching (i.e. text, email, forums and phone)
Ability to read and speak in English and Spanish

Manager, Clinical Information Systems Resume Examples & Samples

Lead the team that supports the database and reporting needs of the Drug Safety and Pharmacovigilance organization. Recruit and retain top performers and provide leadership to CIS team members assigned to one or more applications or customer groups
Manage workload and provide updates on projects, reports, and customer/application status to management
Perform or oversee administration of Argus. Manage the system change process and interact with Drug Safety personnel to improve processes and troubleshoot issues within the system
Manage the intake, analysis, design, and development of complex reports in support of Drug Safety Operations and Safety Evaluation and Risk Management groups. Reports may be for regulatory submissions, safety review or other ad hoc business needs
Oversee system validation activities, including authoring requirements and authoring and/or approving report specifications, test plans and other documentation
Establish and manage service level agreements with end users, both internal and external
Ensure standard processes for assigned customer(s) and application(s) are documented and followed
Participate in the implementation of new systems as a member of the project team, providing technical expertise, analysis, and oversight
Develop and maintain SOPs, Work Practices and Training Guides; ensure documents reflect current practices and are consistent across documents
Identify production support trends for assigned areas and systems; escalate suspected systemic issues to management
Create user documentation and train personnel on applications/reports/solutions, as required
Work with Head of Clinical Information Systems to develop and maintain department tools, templates, guidelines, scripts and systems
Serve as mentor and department resource for system related issues
Sever as liaison to assigned vendors and chair vendor meetings as appropriate
Serve as liaison with IT and QA
Keep current with the latest technology and industry trends; regularly attend training in order to maintain technical and domain expertise
7+ years experience performing the duties and responsibilities listed above
Previous experience providing leadership to a team
Sound understanding of drug safety and pharmacovigilance systems and reporting
Sound understanding of system validation requirements outlined in 21 CFR Part 11
Knowledge and experience to exercise independent judgment and provide indirect oversight to project team members and application administrators in other departments
Experience with business intelligence tools (e.g. Spotfire, Cognos, Business Objects, Tableau, OBIEE, etc.)

Manager, Clinical & Scientific Writing Resume Examples & Samples

Strong clinical skills, with extensive knowledge of oncology/hematology therapy area
Strong writing skills, with a demonstrated record of scientific/medical publication
Familiarity with clinical trial design and statistics and their application to the interpretation and presentation of clinical data
Detail-oriented and experienced with fact-checking and copy-editing
Structured and well organized with excellent work ethic
Ability to organize, prioritize, and maintain high quality work output in a fast- paced dynamic environment while working on multiple projects
Functions well in a team atmosphere
Detailed knowledge of the pharmaceutical industry and experience with issues surrounding the marketing of pharmaceutical products in the global marketplace to include the design and use of health economics and outcomes research studies
Strong project management skills, including establishing project timelines and milestones
Ability to communicate complex material in presentations and discussions in a straightforward manner
Ability to network and partner with important external customers, including pharmaceutical companies, medical thought leaders, academic institutions, large group practices, medical directors and pharmacy directors
Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel) and associated software

Manager, Clinical Quality Consultant Resume Examples & Samples

Oversight through matrixed business partners for compliance actives associated with coding and documentation including provider query
Providing guidance and support related to CMS regulations and Optum Coding Guidelines
Process improvement recommendations around said activities
Supporting best practices for provider engagement
Coding certification required (RHIT, CCS, or CPC)
6+ years ICD coding experience
5+ years’ experience in Risk Adjustment
5+ years of previous experience interacting with providers
3+ years managerial/supervisory/lead experience
Expert knowledge of clinical coding and documentation improvement
Expert knowledge of CMS / Risk Adjustment Rules and Regulations
Up to 25% or more travel required
Clinical license RN, LPN, Pharm D, or equivalent degree
Familiarity with government pay for performance programs a plus
Lead a complex or multifunctional / multi-location team/organization
Proven experience managing organizational growth and change
Master’s Degree in relevant field

Program Manager, Clinical Programs Resume Examples & Samples

Provides program and project management for complex development initiatives
Develops clear and measurable project management plans by defining scope, timelines and milestones
Ensures Clinical Programs savings reports, stakeholder reports and program/project plans are accurate and up-to-date
Effectively and efficiently facilitates program/project related meetings/discussions
Facilitates the review of projects with Senior Management, makes recommendations for action and ensures appropriate follow-up by management to achieve approved program/project objectives
Prepares project/program level reporting by collecting, analyzing, and summarizing data and trends
Meets FWAE savings targets
Participates in the capital request process, as appropriate (e.g., presentations, cost-benefit analysis, business case)
Translates highly complex concepts in ways that can be understood by a variety of audiences
Identifies and implements the appropriate Payment Integrity solution for initiatives through in-depth end-to-end process knowledge
Drives designing new processes or re-designing existing ones to facilitate the execution of programs/projects
Serves as a liaison and resource to OST, Triage and AAL to assist with program/project execution
2+ years of project/program management experience
Ability to establish credibility and build relationships at all levels of the organization
Highly collaborative style; experience developing, implementing and delivering on strategies in a matrix environment essential
Demonstrated strong communication and presentation skills; able to present effectively and persuasively to all levels of leadership
Ability to function independently and effectively in a self-directed environment
Ability to understand and influence the necessary and appropriate actions to ensure program/project success; a bias for action is critical
Proven ability to operate in a highly dynamic environment
Creative-thinking and willingness to ask questions to improve a project or deliverable
Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
Experience managing innovation programs or strategic change management projects
Proficiency with Microsoft Word, Excel, Visio and PowerPoint is required
Previous managed care or provider billing experience
Knowledge of Fraud/Waste/Abuse principles
Registered Nurse and/or CPT/HCPCS coding knowledge
Working knowledge of CMS and state Medicaid regulations

Manager, Clinical Trial Management Resume Examples & Samples

Study Team Leadership
Preparation of Study Documentation
Enrollment of Subjects
Study Close Out
Leadership skills/negotiation skills

Temp-manager, Clinical Trial Management Resume Examples & Samples

Study Planning
Selection and Evaluation of Investigative Sites
Input Clinical Database, Safety and CSR Reports
Project management/organizational skills

Manager Clinical Documentation Integrity Resume Examples & Samples

Assists with the hiring of new CDI staff, interviewing, on-boarding process (access requests, equipment requests, etc.), and orientation to the Department and training
Works with the CDI Director to develop a Clinical Documentation Integrity plan that supports the strategic priorities of UTSW, continuum of care, quality, and coding. Assists to update and create CDI Competency Standards, Policies and Standard Operating Procedures
Demonstrates skill in prioritizing, delegating, and performing a variety of duties within an environment where assignments, priorities, and deadlines change frequently. Demonstrates excellent written and verbal communication skills, critical thinking, decision making and interpersonal skills. Proactively escalates risks and issues to Leadership to ensure timely and effective resolution
Works collaboratively with, and is a liaison to other Departments, Leadership, Service Line Champions, Physicians, and other members of the Healthcare Team
Assists with the development of reports and identifying key metrics to monitor CDI program success. Analyze reports to identify opportunities for process improvement and educational opportunities for CDI staff, Coding staff, and Physicians
Develops recommendations as appropriate for documentation templates and physician queries based on coding and regulatory changes, and data quality review findings
Responsible for productivity and accuracy of CDI staff ensuring that education, auditing, and feedback are given on a consistent basis. Promotes collaboration and teamwork by involving the CDI team in planning, and decision-making. Ensures CDI staff understand their role and responsibilities in achieving CDI program and organizational success

Manager, Clinical Special Projects Resume Examples & Samples

Do you love working in a dynamic environment?
Do you thrive in a culture that values Service Excellence, Integrity, Team, Continuous Improvement, Accountability, Fulfillment and Fun? If so, DaVita Rx is the perfect fit!
The ideal candidate will have exceptional written and verbal skills
Strong experience communicating with executive level teammates
Ability to manage day to day operations for key programs with a laser focus on metric driven execution, troubleshooting and improvements
Proven track record in operational design and program development
Experience leading and executing large growth initiatives in fast paced, dynamic environments with a Get Stuff Done attitude!
Exceptional problem solving and analytical ability
Manage the development, piloting, deployment and outcomes of new clinical programs in a systematic manner, including taking accountability for managing timelines, deliverables, and budgets
Define and drive analytics to better characterize patient populations, inform program design, define success metrics, and track progress and outcomes
Lead operational design for key initiatives, including operational workflows, clinical workflows, policies and procedures, compliance, training materials, success metrics etc
Work with Information Technology to update, design and/or develop software changes to support the implementation of clinical programs and drive outcomes performance
Manage day to day operations for key programs with focus on metric driven execution, troubleshooting and improvements
Build relationships with, and coordinate across, external partners and key internal stakeholders (business and clinical leaders, IT, marketing, finance, legal, compliance) for program design, improvements, implementation, and reporting
Create and present materials for readouts to leadership as needed
Strong background in healthcare
Experience in consulting or healthcare services/operations preferred (i.e. healthcare services design, services launch, services delivery); prior experience working with payors, physician networks, pharmacies preferred
Ability to balance strategic goals and execution capabilities to drive results with new clinical programs
Strong strategic thinking and problem solving ability, comfortable with basic operational and financial analysis
Detail oriented thinker, with ability to design effective and efficient workflows, policies, and metrics
Team player with ability to influence and work closely (on a day to day basis) with external and internal partners effectively through building trust and credibility quickly
Strong project management skills and ability to balance multiple/changing priorities
Ability to handle ambiguity and drive design of new models of care
Proficiency in Powerpoint, Excel, Visio
Willing to travel 30% of the time

Manager Clinical Services Outpatient Nephrology Days-south Tacoma & Puyallup Resume Examples & Samples

Must be a graduate of an accredited School of Nursing
BSN or Bachelors’ Degree in a related field is preferred
Three years’ experience and clinical knowledge in the same or similar clinical specialty
Two years in a charge nurse/ leadership or equivalent position required
Clinical knowledge as a Registered Nurse in the same or similar clinical specialty preferred

Manager, Clinical Project / Task Resume Examples & Samples

Serves as a licensed clinician with technical or functional expertise supporting one or more clients
Performs highly specialized clinical analysis, literature reviews, best practice analysis to ensure current clinical guidelines are are integrated into technologies
Works with clients to identify business needs and coordinates a plan to meet the bussiness needs
Applies clinical expertise and experience to significant business projects or processes
May perform business development activities, including providing clinical input to proposal efforts
Will serve as a task or project leader
8-10 years of related experience, including supervisory experience
GDITHCSD

Manager, Clinical Services Resume Examples & Samples

Minimum of (2) years’ experience in a Research Laboratory In Vivo field
Minimum of (1) year experience in a Research Laboratory In Vivo field
AAALAS certification
LATG
CMAR
Minimum of 2 years’ experience in research laboratory in vivo field

Manager Clinical Documentation Program Resume Examples & Samples

The analytical abilities necessary to formulate policies and procedures, prepare various reports and records, assists in the development of department budgets. The interpersonal skills necessary to interact with all levels of department personnel, other departments, physicians and individuals from outside the Hospital
Leadership skills including demonstrated willingness to pursue leadership roles with increasing levels of accountability, comfort with decision-making responsibilities, coaching, teaching and counseling skills, and the ability to inspire and build confidence in others
3-5 years of progressive supervisor/managerial experience. 5 years of inpatient coding and/or recent nursing experience in medical/surgical in an acute care setting

Account Manager Clinical Resume Examples & Samples

Onderhandelingsvaardigheden
Kan zelfstandig werken
Teamspeler
Flexibel
Doorzetter
Kennisniveau van de verkopen producten en verkoopvaardigheden op peil houden

Manager, Clinical Administration Resume Examples & Samples

Supporting a team of non-clinical support staff responsible for Medicaid contractual requirements. Will need to manage teams through performance management reports to hit targets, as well as foster an environment of engagement within the team
Impact of work is most often at the National level
Sets team direction, resolves problems, and provides guidance to members of own team
May oversee work activities of other supervisors
Manage activities that include analyzing, reviewing, forecasting, trending, reporting, and presenting information for operational and business planning
Evaluate performance metrics to deliver programs to drive consumer outcomes, client return on investment and productivity improvements from better processes and technology
Support short and long term operational/strategic business activities
Develop and implement effective and strategic business solutions through research and analysis of data and business processes
Provide leadership and support in the areas of quality, productivity, and customer service
Utilize critical thinking, communication, and change management skills to drive productivity
Work cross-functionally with team members, SME’s, and other departments to achieve program goals on time and on budget and plan future business needs
Monitor and facilitate workflow, maximizing resources to provide quality, consumer and company focused services
Identify problem areas and develop contingency plans
Deliver excellent customer service maximizing customer growth
5+ years of behavioral health or health-related field experience
Project planning and management experience
Expertise in using PC based tools
Excellent written, presentation, and verbal communication skills
Coaching and mentorship skills
Self-motivated worker

Manager, Clinical Administration Resume Examples & Samples

Impact of work is most often at the local level
This is an office based position in Sugarland, TX
5+ years of experience in wellness or other health-related field

Manager, Clinical Data Programming Resume Examples & Samples

Manage clinical data programming tasks for multiple studies
Provide programming support for study team members from the study start up to the end
Review/generate specifications for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards
Perform data reconciliation, data quality control, and program SAS edit checks
Generate all necessary outputs (table, listing, figures) for ongoing data review meetings and RBM using SAS and Spotfire
Review/generate/validate electronic submission deliverables such as SDTM datasets, Define.XML, aCRF, Reviewers Guide
Perform Quality Testing/User Acceptance Testing of EDC systems
Provide adhoc listing, reports and graphs to various teams on request from the ongoing and legacy studies
Support quality control and quality audit of deliverables
Contribute to activities in validation and implementation including standard reporting systems, SAS macro utility programs and associated tools
Minimum of 5 years’ of hands on SAS programming experience in a pharmaceutical environment
Strong understanding of clinical trial data
Strong understanding of relational database components and theory
Strong understanding of SAS Programming
Experience with SAS Drug Development
Experience with Pinnacle 21 Enterprise to validate and design studies
Experience with Medidata Rave
Experience with Sportfire
Strong knowledge of regulatory requirements and guidance (e.g. GCP, ICH)
Strong knowledge of industry standards with at least 5 years of hands on experiences (e.g. CDISC SDTM, ADaM, ODM, Define.XML)

Manager, Clinical Management Resume Examples & Samples

Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports
Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables
Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
Performs report review for assigned CRAs
Performs onsite performance assessment visits annually for assigned CRAs
Conducts face-to-face training with new hire CRAs to the program as needed
Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
Ability to utilize problem-solving techniques applicable to constantly changing environment

Manager Clinical Analytics Resume Examples & Samples

Responsible for clinical analytics to support commercial, Medicare Advantage and Medicaid managed care payer contract renewals for Dignity Health hospitals and medical groups
Analyzes utilization data to provide insight into clinical performance enhancement opportunities
Manages the planning and direction of departmental projects and operations. Sets direction and priorities regarding areas that require more in-depth analysis
Prepares and delivers clinical analytics to corporate managed care personnel and other senior management
Serves as key liaison with third-party payer personnel to represent Dignity Health results
Directs and manages professional finance staff and participates in key project teams
Participates in various aspects of key cross-functional assignments
Participates in staff interviewing, performance evaluation, performance management
Able to assign, direct, review and perform work as well as related follow up and coordination activities
Able to provide training and assistance on a full range of finance issues to internal and external staff
Bachelors degree in Finance or Accounting or equivalent experience. Advance degree and/or CPA preferred
Seven years demonstrated in-depth healthcare finance experience, of which at least three years are in a supervisory/management capacity
Extensive experiences in analyzing clinical savings opportunities
High degree of advanced analytical and problem-solving skills with specific application to hospital, medical and actuarial data
Working knowledge of information systems and their application to managed care and hospitals
Working Knowledge of MS-DRGs, APCs and other coding methodologies as they apply to managed care
Working knowledge of risk scoring techniques and measurement of healthcare utilization against benchmarks
Working knowledge of disease management analyses
Has functional and cross functional area project experience
Able to guide, lead and oversee staff while providing clear and accurate information regarding tasks, assignments, policies, etc
Exhibits strong understanding of business strategies
Maintains effective working relationships within and outside managed care while gaining the confidence and trust of client management
Uses appropriate communication vehicles; understands audience and uses the best method of conveying a message

Manager Clinical Data Resume Examples & Samples

Minimum of two years of experience in healthcare and project management
Excellent verbal and written communication skills, willingness to learn, comfortable and skilled at working with physicians and healthcare providers, excellent computer skills including excel
Proficient in excel and experience with other statistical software
Highly developed problem solving skills, ability to manage programs and projects

Manager, Clinical Administration Resume Examples & Samples

Supporting a team of non-clinical support staff responsible for Medicare contractual requirements. Will need to manage teams through performance management reports to hit targets, as well as foster an environment of engagement within the team
Impact of work is most often at the LOCAL Regional level
Ability to interact positively and professionally with co-workers and internal/external customers
5+ years of healthcare experience or health-related field
Knowledge of health industry and associated regulatory requirements
Expertise in using PC based tools – Microsoft Suite (Word and Excel)
Knowledge of healthcare process how various components and systems tie together (pre –authorizations, UR, Clinical Reviews, Claims, Network, etc.)
Minimum of 3+ years of Direct Supervisory Experience
Analytical and Comparison Skills

Manager, Clinical Labelling Systems Resume Examples & Samples

This position is responsible for leading and managing the design, creation, printing, receipt/control and destruction of primary and secondary packaging labels utilized in packaging and distribution of stability, analytical, commercial, and clinical trial material. This also included the creation of and control of randomization for clinical trial studies as well as all clinical labeling systems and technology
Manage the overall function of label receipt, creation/design, inspection, receipt/control, storage, destruction, and release
Communicate label status to other pertinent functional areas concerning Label issues and status
Liaise directly with Pre-Production, Scheduler, Warehouse and Production to ensure proper staging of materials per timelines
Partner with Packaging Engineering on label design requirements
Monitor and report metrics for on time delivery, and CCP
Manage the creation of all label inspection packets prior to the arrival/printing of all labels (English, foreign text, booklet, multi-panel, CRF, open-label and randomized)
Manage the creation of and/or formatting all randomization codes
Adhere to and manage labeling project timelines to ensure the label proofs, randomizations and printed labels are ready within the agreed upon timeframe
Correspond with Production staff and assist in follow-up of label issues and destruction
Interact with Project Managers and other personnel from various Catalent divisions on label generation and requirements
Ensure compliance with all FDA (GMP / GCP) regulations. Implement standard operating procedures (SOPs) and training documentation
Ensure Label Control efficiency and cost effectiveness through optimum utilization of resources and ongoing
2 – 5 years relevant experience in the pharmaceutical industry

Manager, Clinical Analytics Resume Examples & Samples

Develops and maintains systems that allow for ease of data retrieval and manipulation from a variety of sources including claims payment, utilization management, health plan risk pools, subcontractor capitation, internal charges, subcontractor risk pools and others
Audits and recovers claims overpayments, capitation revenue underpayments by the health plan (e.g., ESRD, Institutional), inappropriate risk pool expense deductions (HealthNet Aids and Transplants), and other areas identified as a cost benefit to direct audit and recovery efforts
Assures accuracy and timeliness of subcapitation payments
Develops systems to assure the timeliness if risk pool reconciliations
Develops financial models for new ventures
Performs historical studies to forecast future costs
Develops subcapitation and risk pool models
Develops models to evaluate provider contract proposals
Identifies trends in claims expenses and recommends methods for reduction
Coordinates requests for analysis from internal and external clients including assignment, mentoring and establishing timelines
Performs research on industry performance measures for evaluation of client performance
Develops departmental and individual goals
Ensures accuracy and readability of for all team projects
Proficient in Microsoft Office applications (Word, Excel, Access)

Manager Clinical Data Resume Examples & Samples

Oversee all clinical data registries and clinical performance databases both internal and external
Oversees and manages all clinical data analytics including relevant HCA and local systems
Provides supervision or through matrix reporting of all staff performing abstraction or data entry for clinical data registries, publically reported databases or similar processes
Monitor division and corporate clinical excellence and performance improvement initiatives and programs including analyzing corporate and division dashboards
Routinely and at a minimum of annually, participates in the review and update of the Quality Assurance and Performance Improvement Plan by conducting evaluations
Assures that practices are evidenced-based and consistent with regulatory guidelines to include core measures
Provides ongoing Orientation, Education and Training pertinent to quality assurance and performance improvement based on customers’ needs assessments
Facilitates and as needed leads continuous quality improvement teams using the FOCUS PDSA methodology as well as LEAN and Six Sigma
Monitors key performance indicators and performance improvement including the use of control charts, statistical analysis and gap detection
Using LEAN, Six Sigma and other quality improvement methods does process analysis to include barrier, efficiency and opportunity for improvement analysis with process mapping
Executes position responsibilities that demonstrate leadership, experience, and creative approaches to management of developmental needs that contribute to the enhancement of patient care
Regularly communicates PI and quality/safety activities to leadership and QM staff
Utilize conceptual and diagnostic skills to prioritize and manage projects in an effective manner
Coach and facilitate prioritized quality initiatives to achieve desired outcomes
Facilitate teamwork and communications to assure optimal outcomes in the provision of quality improvement services to the organization
Facilitates understanding and implementation of systems for quality improvement purposes
3 - 5 years (Project Management)

Genetics Screening & Tracking Manager Clinical Services Resume Examples & Samples

Develops, implements and ensures high quality and cost effective clinical genetics services
Develops and monitors the quality assurance program, assesses clinical services developmental needs for short and long range plans
Manages human resources
Develops and monitors the clinical services budgets and staffing plan
Identifies opportunities to reduce costs, change staffing mix, and improve services
Ensures staff complies with established policies and procedures, federal, state and local requirements
Manages the department clinical caseload
Ensures accessibility and timely services
Provides clinical expertise for the more complex cases
Identifies service and operational problems and issues
Provides project management support to identify research, develop and implement solutions
Oversees the implementation of new services, procedures, and computer systems and changes
Ensures programs are in compliance with federal, state, and local requirements
Identifies areas which require additional support to better service their clients
Provides genetic counseling services for all areas of medical genetics, including pediatric, prenatal, adult, and cancer referrals
Ensures membership service complaints are investigated and action taken
Participates in the development of regional clinical policies and procedures, and administers programs
Minimum five (5) years of experience as a genetic counselor

Manager, Clinical Pack & Label Outsourcing Resume Examples & Samples

A degree in pharmacy, mechanical, packaging or chemical engineering or by experience are preferences
A minimum of 8 years related work experience in a clinical supply environment is required
Excellent written, verbal and presentation skills with experience in working with cross-functional, cross-sector teams are required
Experience with outsourcing and contract oversight, experience managing P & L budgets at a trial or compound level is required
Excellent project management skills are required
Experience with process development, launch and implementation of global clinical supplies systems is required
Excellent time management, priority setting and communications skills required
Effective leadership skills and proven ability to foster team productivity and cohesiveness is required

Manager Clinical Statistics Resume Examples & Samples

PhD or MSc(or equivalent) in a statistical discipline
Experience in the design, execution, analysis and interpretation of clinical trials
Excellent interpersonal and communication skills; record of building and maintaining strong working relationships; demonstrated ability to explain novel and standard methods, both to fellow statisticians and to scientific and clinical colleagues
Strong time management skills; able to effectively organise and manage a variety of tasks across different projects
A good understanding of drug development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and/or business objectives
Experience providing support for publications (both analyses and review)
Experience of working with, and coordinating CROs
Experience with modeling and simulation, and other innovative methodologies
Providing statistical input to the design, analysis, reporting and interpretation of clinical studies
Study responsibility within one of GSK's key therapeutic areas: ID (Infectious Diseases and Oncology) Respiratory, MPC (Metabolic Pathways and Cardio Vascular), II (Immuno Inflammation) or ADD (Advanced Drug Development)

Manager, Clinical Statistics Resume Examples & Samples

Experience supporting product life-cycle management
Experience in submissions and interacting with regulatory bodies
Demonstrated innovative thinking and excellent communication skills
Excellent influencing skills, which are applied effectively at all levels of an organization and across multiple functions
Self-motivated, independent worker
Proven ability to project manage and prioritize activities
Influencing clinical development plans, regulatory and commercial strategies
Building and maintaining effective strategic working relationships with internal and external partners to meet business needs
Identifying, developing and implementing novel statistical methodologies in support of medicines development and product life-cycle management

Manager, Clinical Statistics Resume Examples & Samples

Expertise in a broad range of statistical methodologies
Prior experience with pharmacokinetic and pharmacodynamic (i.e., biomarker) endpoints; and linear as well as nonlinear dose response modelling with application to real problems is a plus
Demonstrated leadership and capabilities to reach across functional lines to support and manage a wide variety of tasks across different projects
Excellent influencing skills, which can or have been applied effectively at all levels of an organization and across multiple functions

Manager, Clinical Quality Assessment Auditor Resume Examples & Samples

Independently manages and performs compliance audits of Contract Research Organizations (CRO), Systems and Clinical Investigator sites for Phase I to IV clinical trials performed by the CSO Platform. CRO / System audits include external and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, GCTM, study start up, DRS etc. Lead both routine and complex directed audits. During Investigator site audits, the Manager, CQA Auditor has direct access to subject individual data for records review. The Manager, CQA Auditor is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information
Represents CQA on various project/study team meetings. Acts as GCP Project Representative to provide quality and continuous improvement support at the study/project level. This includes responsibilities such as: (a) Follow-up on progress status of assigned project(s), (b) Establishment of regular contacts with operational teams, (c) Advice and consultation on GCP and Quality issues, (d) Identifying and analyzing potential issues with impact on quality, (d) Contribution to audit planning / programs and assistance in the monitoring of the implementation of those programs, (e) Participation in the analysis of results of audits for the assigned projects and (f) Proposing improvements and/or process changes
As requested by CQA Management may represent the sponsor during Regulatory Inspections. This will include preparation, coordination and communication to management
In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance
When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner
Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc
Participates in the development, revision, and implementation of CQA Quality Documents, working methodologies, tools and systems
Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia
Supports the coaching of less experienced and / or newly hired GCP Quality Assurance Specialist(s)
Bachelor degree in a life / medical / natural sciences or scientific discipline or related area
Minimum 3 years related experience
Ability to travel (25%+)
Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance
Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain
Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel
Good business communication skills in English (orally / in writing)
Good analytical abilities and attention to detail
Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity
Ability to deal with multi-cultural environments
Capacity to work in team oriented environment
Current regulatory knowledge

Manager Clinical Quality Middle Tennessee Resume Examples & Samples

Oversees the implementation of plan EPSDT quality improvement program
Works to coordinate the work within C&S Quality in order to improve EPSDT performance and to close gaps in care
Manages EPSDT Playbook or work plan programs and activities
Collaborates across business segments to achieve goals and targets
Develops and maintains positive relationships external state organizations within the scope of Quality Improvement
Helps ensure the creation, integration, maintenance, approval of the quality improvement Playbooks or work plans
Continuously monitors EPSDT interim results and adjust programs to insure meeting targeted goals
Manages compliance with TennCare Kids contractual requirements and annual EPSDT audit
Supports PIPS, accreditation, and regulatory audits as needed
Develops, mentors, and coaches staff
Clear, active RN license in the state of Tennessee
5-8 years of experience in leading an integrated and progressive quality organization, preferably within health care industry
5+years of managerial experience with direct reports
Relationship focused
5+ years of experience with demonstrated functional knowledge of process improvement, quality improvement, and change management
Strong written and oral communication skills with internal and external partners and employees
Experience with Corrective Action Plans
Change management experience and demonstrated skills
Demonstrated staff development skills
Strong team building, collaboration and motivational skills
Knowledgeable of the managed care/health insurance industry, products and services
Knowledge of NCQA accreditation standards, HEDIS, EPSDT, STARS, Regulatory Adherence and Performance Improvement Projects

Senior Manager, Clinical Affairs Resume Examples & Samples

Work in conjunction with Clinical Science to develop clinical trial strategies and protocols by collaborating with Investigators, Regulatory, Marketing, and R&D to develop clinical trial strategies, plans and protocols
Development includes knowledge of relevant medical literature, regulatory environment, marketing requirements and the performance characteristics of the devices
Partnership with resources for statistical and data management plans is required, as well
Oversee and manage a clinical team to assure clinical trials are executed successfully - this includes site development and management, subject recruitment, maintenance of data integrity and regulatory compliance, project timeliness, budget oversight and all aspects of study communications
Develop study materials to support trial conduct such as case report forms, investigator brochures, and core lab documents
Develop and manage performance metrics (trial and personnel) for internal and external resource assessments
Develop and manage relationships with key medical and scientific investigators, CECs, DSMBs, CROs and Core Laboratories - activities would include contract negotiations, developing vendor milestones and metrics for efficient trial conduct
Develop and manage trial budgets to key business objectives
Lead, maintain and anticipate regulatory compliance objectives and documentations requirements in US and international trial executions
Ensure that safety requirements are met through adverse event reporting which may also include support of medical monitoring, CEC review and DSMB review as individual trials require
Facilitate and participate in clinical trial reports on all aspects of a study for regulatory submissions, marketing support and other business needs
Support regulatory and quality assurance requirements throughout the product life cycle - this may include special reports for regulatory body requests, complaints, product investigations, marketing needs or other customers
Develop, manage and oversee the staff and communication requirements (internal and external) to meet clinical trial needs in an effective and efficient manner
BS in Life Sciences, advanced or professional degree preferred
Minimum of 10 years’ experience in medical device industry
Track record of clinical trials management and execution for medical devices
In-depth knowledge of regulatory compliance requirements for FDA and CE Mark
Work in Japan would be considered a plus
In-depth experience in cardiovascular and peripheral vascular devices desired

Manager Clinical Auditing Resume Examples & Samples

Current RN license or licensed psychologist or social worker
5 years experience in inpatient Behavioral Health services. Experience as an Executive Leader is preferred
Must have strong working knowledge/understanding of hospital systems and operation as well as health care federal guidelines and regulations
Experience with state and The Joint Commission standards and survey processes, Hospital Quality/Risk Management, legal reviews, and Case Management
Ability to develop and implement review tools to effectively identify and capture the information required by legal, compliance, QM, and other requestors that results in a report that succinctly describes issues identified
Ability to interact with all levels of Tenet’s Home Office and hospital personnel and outside Legal Counsel
Excellent computer skills. Ability to learn and effectively utilize the IS applications (Compliance Central, InterQual, eCare, HPF, Exel, etc.) unique to Tenet that will be used to access, interpret and report data

Manager, Clinical Services Resume Examples & Samples

Establishes and oversees staffing to ensure the efficient, effective and safe completion of therapeutic apheresis procedures while meeting hospital needs and physician requests
Hires new staff and ensures that new staff meets all requirements of training plan
Maintain knowledge of therapeutic apheresis procedures and may perform therapeutic apheresis procedures when needed ensuring safe and appropriate care of patient
Contributes to the development and monitors implementation of local operating procedures, quality control procedures and staff training protocols to assure compliance with American Red Cross Blood Services Directives, Code of Federal Regulations (CFR), industry standards such as FACT and AABB, and local policies and procedures
Manages budget; ensure that costs are recovered and that budget targets are met
Supervises assigned staff in accordance with personnel policies and bargaining unit contracts including evaluating performance, recommending disciplinary actions and providing appropriate input in hiring and firing decisions to enhance the success of operations and minimize turnover
Performs periodic operational audits of assigned area to assess efficiency and effectiveness of current methods and improve productivity in support of organizational goals
Oversee and manages all research activities/collections in the Therapeutic Apheresis Unit, if applicable
Works with hospital marketing and Medical Director to ensure customer needs and concerns are addressed

Manager, Clinical Resume Examples & Samples

Responsible for recruitment and selection of Clinical staff
Reviews reports and statistical data to insure unit goals are being achieved
Provides leadership, direction and guidance to assigned staff
Effectively addresses personnel issues in order to promote a productive and healthy environment
Improve clinical processes and policies in support of the organization mission
Builds on existing relationships, builds trust, and inspires teamwork to encourage skill building and risk taking
Works closely with stakeholders and secures organizational cooperation for needed changes
Design, develop and implement Quality/Training initiatives that ensure compliance to Lincoln Disability product requirements and Customer Service standards while developing strong partnerships across the Disability Organization
Understands the "big picture" and able to translate changes in business environment to opportunities within the clinical department
Monitors attainment of CEUs for staff to maintain required certification and licenses
Manages external vendor relationships with focus on quality and cost containment
Approves and makes more complex claim management related financial decisions consistent with company guidelines for assigned area(s) of responsibility
Collaborates with internal and/or external stakeholders to ensure effective service delivery of more complex claims for assigned area(s) of responsibility
Collaborates with sales offices to ensure effective service delivery of claims for assigned area(s) of responsibility
Completes regular quality audits of assigned area(s) of responsibility claim/team members' work; records results and counsels staff to bring work to or above standards
Develops and maintains close customer ties, articulates customer needs, keeps priorities in focus with the desires and expectations of the customer
Ensures all assigned area(s) of responsibility claims, eligible or ineligible for payment, conform to quality, production standards and specifications
Ensures claims processing is consistent with applicable policies, procedures and department guidelines for assigned area(s) of responsibility
Identifies and communicates claims trends and issues to management. Develops mitigation plans
Identifies process inefficiencies and cost reductions. Develops and recommends mitigation plans
Manages the processing and administration of all aspects of more complex claims for his/her assigned area(s) of responsibility ensuring accurate and timely claim management
Monitors and evaluates overall metrics for team productivity and takes appropriate action to meet or exceed standards
Provides more complex technical guidance to claim team members on claims adjudication for assigned area(s) of responsibility
Reviews and resolves more complex escalated issues and concerns for assigned area(s) of responsibilities
Reviews regular quality audits of for assigned area(s) of responsibility claim team members work, analyzes results and counsels staff to bring work to or above standards
Requires current Registered Nurse License, BSN preferred
Certified in Case Management (CCM) is desired
Previous management or supervisory experience preferred
Disability or Worker’s Compensation experience is preferred
Two or more years with insurance experience is required
Medical terminology is required
Three to five years of disability claims experience is required
Strong knowledge of IBM software programs including but not limited to: Word Processing software, Spreadsheet software, and e-mail
Completion of Group HIAA, LOMA, ICA, and other industry courses is desirable
Excellent analytical, problem solving and communications skills are required

Manager, Clinical Programming Resume Examples & Samples

A minimum of 10 years of programming experience, including 5 or more years of clinical SAS experience in a lead position
Bachelor s Degree or Master s Degree in a related discipline or related experience
Previous project leader or lead programmer experience
Comprehensive knowledge of the drug development process, FDA regulations pertaining to clinical programming, ICH guidelines, and the electronic submissions process mandatory
Strong SAS programming and proactive problem solving skills
Strong organizational, interpersonal, and communication skills
Ability to constructively interact with programming teams, project management, and sponsors on a regular basis
Ability to insure adherence to good clinical and programming practices and maintain exceptional quality standards
Ability to manage resources, timelines, and workflow in a fast paced environment mandatory
Extensive knowledge of SAS programming, SDTM, ADaM, FDA, and ICH guidance
Good understanding of clinical data and pharmaceutical development

Manager, Clinical Quality Processes Resume Examples & Samples

Ensures team meets established performance metrics, performance guarantees, and quality standards
Manages administrative and clinical operations consisting of field based and / or contact center based staff
Manage relationships with physician practices
Manage implementation of new physician practices and deployment of resources
Takes the lead role in setting direction and participating in or developing new programs
Provides leadership to and is accountable for the performance and direction through multiple layers of management and senior level professional staff
Work most often impacts a large business unit, or multiple markets/sites, or at the segment / market group level for functional staff positions
Drives performance through audits and coaching to team personnel to ensure products and services fully meet the client expectations while maintaining efficient and profitable operational delivery
Assure the onboarding and training of new and existing staff to support product growth and service enhancement
Bachelor’s Degree in applicable area of expertise or equivalent experience
3+ years of Healthcare industry experience
3+ years of supervisory experience
Effective skills in motivating and mentoring others
Demonstrated ability to identify with a consumer in order to understand and align with their needs and realities
Project / Product coordination/management skills
HEDIS experience

Manager Clinical Outsourcing Resume Examples & Samples

Partner with clinical study leads and functional experts to create specifications for work to be outsourced (RFPs)
Facilitate creation and execution of all outsourcing-related documents (CDAs, MSAs, Initiation Work Orders, Contracts, Change Orders, etc.)
Obtain quotations from service providers and analyze proposals from quality, timeline and cost perspectives in order to make recommendations
Manage the review and negotiation of contract terms and partner with Legal, Finance and other internal stakeholders as needed to finalize. Ensure compliance with required corporate financial approval policies
Service Providers are contracted with enough foresight to allow timely trial start and execution
Negotiate, establish and communicate clinical outsourcing timelines to internal and external customers and partners
Negotiate proposals with service providers to ensure deliverables are efficient and cost-effective
Timely execution of clinical outsourcing-related documents
Minimize the number of Change Orders during projects
Manage RFP process (including vendor identification, evaluation and selection) for clinical service provider needs for clinical studies of various phases, sizes, complexity and risk. as appropriate
Obtain comprehensive proposals, provide analysis of all proposals
Manage and lead contract and financial negotiations with external service providers including analysis of detailed scopes of work, exhibits, payment terms, budgets and Change Orders
Manage negotiation of payment terms and schedules, invoice review and required approvals based on contracted activity and spend, tracking to budget/plan, escalation and resolution of payment issues
Work closely with clinical team to prepare study specific RFPs based on clinical protocol and submit to prospective vendors

Manager Clinical Processes & Initiatives Resume Examples & Samples

Current active and unrestricted RN license in same state of residence
3+ years' clinical RN level professional experience
3+ years' of project management, leadership, supervisory, or management experience
Ability to manage multiple complex, concurrent projects
Proficient with Microsoft Word, Excel, Outlook, PowerPoint
MSN degree
Planning and organizational skills to demonstrate leadership and initiative
HEDIS / Star Quality experience
Experience working with Medicare and Medicare Advantage Plans

Senior Manager, Clinical Programming Resume Examples & Samples

Collaborate with CIS in developing and maintaining SAS® Applications/Tools/Utilities that support programming activities to ensure accuracy, completeness, quality, and timely delivery of clinical programming (CP) deliverables at the product and study level
Creating & maintaining documentation describing the use of SAS® Applications/Tools/Utilities
Conducting trainings ensuring SAS® Applications/Tools/Utilities are used as intended and also help programmers to enhance SAS® programming skills
Providing SAS® technical support – act as first line support for clinical programmers and escalate as needed. Work with CIS, IT and other groups to resolve escalated issues
Assist in evaluating SAS® programming expertise of candidates thereby facilitating recruitment of high performing programmers
Contributing to the development of departmental processes, and procedures
Interpret industry & regulatory guidance and facilitate compliance to industry and regulatory standards
Collaborate with cross-functional teams with implementation of third party/off the shelf applications supporting statistical programming activities. Act as a CP business champion for technology where is CP is the system owner
Actively engage in knowledge sharing with cross-functional teams and represent clinical programming department on projects facilitating companywide infrastructure development initiatives
Provide SAS® programming support for a variety of activities including but not limited to creating outputs for: integrated analyses, clinical study reports, safety monitoring, manuscripts, conferences, ad hoc analyses, and exploratory analyses
Lead programmers efficiently across infrastructure projects by setting goals and providing oversight, guidance, mentoring, and feedback
BS or equivalent relevant education and 10+ years or MS/PhD and 8+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education
Advanced SAS® skills with expertise in SAS/STAT, SAS/GRAPH, SAS/ACCESS
8+ years of experience in developing applications/tools/utilities using SAS® for creating & testing Analysis Datasets, Tables, Listings and Figures for Phase I-IV clinical studies
8+ years of experience in writing SAS® Macros
8+ years of experience with building databases using SQL or any other programming languages/software
Experience implementing CDISC standards
Positive, professional attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area

Manager Clinical Quality Resume Examples & Samples

Requires a BS in nursing or a health care related field; 3 years of managed care experience, including experience in program development and knowledge of the quality process and QI techniques; 2 years of supervisory experience; or any combination of education and experience, which would provide an equivalent background
MS in nursing or related clinical field and CPHQ preferred
RN is required
Experience managing at least 5 direct reports is required
HEDIS experience preffered

Manager Clinical Affairs Resume Examples & Samples

Day to day Clinical trial operations management; Clinical Project management
Study Related Material Development and Review
Site/CRO/Investigator Management responsibilities
Coordinate and assist with the development and execution of the clinical research strategy to meet current and future business needs
Elevate known risks and issues to Sr. management as identified
Provide direction and facilitate the preparation of clinical research plans
Provide strategic clinical input into research programs
Assist team in the resolution of clinical issues that impact successful project completion
Communicate clinical study milestones and department resources needed for project success to Sr. management
Present of clinical data to internal/external customers
Oversee project management of the following: documentation system, training files, internal QA system, and Oracle Clinical
Ensure the company complies with applicable laws and regulations with respect to clinical research
Responsible for providing input to set overall study timelines and budgets

Manager, Clinical Data Sciences Resume Examples & Samples

Clinical trial experience
End-to-end global medicine development experience
Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area. Demonstrates scientific principles, practices and procedures to the clinical development process, knowing when and how to balance scientific and commercial interests to ensure optimum conditions for success
Single point of accountability for data management deliverables at an assigned level (asset, project or study) within a given clinical development program
Expert input to protocol and other plans at the development phase of a study
Expert input to the strategic delivery plan for data capture tools across the studies of a clinical development program
Development and management of study validation and integration plans, including the validation plan, dataset definition and external data sources
Expert input to Asset Strategy and Clinical Data Stewardship
Lead role in developing strategic partnerships
Lead role in the management of the data vendor deliverables and performance
Maintains Data Management Study File
Expert application of data management and data quality tools to efficiently deliver clinical development plan objectives
Data compliant with GSK’s principles of data integrity in support of building public trust and maintaining GSK’s corporate reputation
Purposeful challenges to the amount of data collected and validation efforts, driving a focus on fit for purpose and decision-making avoiding re-work
Clinical data stewardship with the effective development and use of standards and maximizing data re-use
Ensure clear delivery from data vendors and partners are compliant with GSK’s principles of data integrity
Provides data quality feedback to site staff and monitors on a regular basis and identifies when re-training needed
Direct or matrix management and oversight of the deliverables from Clinical Data Scientist Professionals. Includes staff located in multiple countries across multiple R&D sites
IPE and EPE budget forecasting and on-going budget management of data management operational contract staff and third party vendors for the assigned level (project or study)
LI GSK*

Manager Clinical Systems Resume Examples & Samples

The Manager Clinical Systems will be responsible for oversight and management of implementation and maintenance of clinical systems used by the Medical Device Clinical Research Center of Excellence
S/he will be responsible for ensuring the clinical systems and associated study specific configurations are developed and maintained in accordance with J&J standards, policies and procedures, while meeting timelines and budgets
Interface with Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
Be responsible for project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant systems
Develop and maintain project timelines for study-specific systems set-up, UAT, maintenance and closeout as required
Train users in activities related to system set-up, UAT and ongoing maintenance as well as other relevant processes
Ensure prompt resolution of critical issues and provide timely and accurate responses to users
Serve as first line of contact for all support requests through system go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
Ensure efficient use of resources across the CoE to provide high quality clinical systems, on time and within budget by monitoring progress and conduct of their team’s respective projects
This includes support of all clinical systems and requires active partnering with Clinical Operations, Franchise, Biostatistics and Data Management and Medical Affairs as well as Information Technology and Computer Software Validation
Provide leadership, direction and mentoring for their respective staff including staff personal development
Ensure all projects are adequately resourced to meet project deliverables and ensuring clinical system tasks remain on target to project timelines
Serve as first line of contact for initiation and identification of resources required for study build: Systems may include: CTMS, eTMF, IxRS, EDCs
Responsible for the delivery of operational clinical systems
Provide design expertise to implement clinical system solutions
Lead all clinical system activities from identification of a need for a new system or clinical study configuration through final extract or decommission of clinical systems, partnering as appropriate with Clinical Operations, Franchise, Biostatistics and Data Management and Medical Affairs as well as Information Technology and Computer Software Validation
Create, review and facilitate approval of system and study deliverables and facilitate appropriate quality review (including access reviews) where applicable
Participate in vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems
Analyzes complex change requests to determine feasibility for incorporation within clinical studies
Collaborate with Data Management and Clinical partners to define, document and implement system standards
Develop and maintain of global harmonized processes and procedures for all clinical systems and support functions
Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes
Define, develop and implementation of clinical system metrics; Enterprise initiatives
Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed)
A Bachelor’s degree in Statistics, Computer Science or related discipline (required), with at least 8 years of system support in clinical research within Medical Device or Pharmaceuticals and at least 1 year of supervisory experience
Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies is required
Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required
Strong proficiency in more than one Clinical system is preferred
Advanced certification preferred
Demonstrated ability to lead in a team environment to deliver critical milestones is required
Experience with CDISC STDM preferred
Knowledge of GCP and SDLC

Product Manager Clinical Applications Resume Examples & Samples

You define the key product functionality for clinical applications and contribute to the product strategy of the computed tomography business
You contribute to the product roadmap and ensure consistent user experience across the entire application portfolio
You develop an in-depth clinical knowledge and market understanding through intensive customer interactions
Furthermore, you are responsible for the requirement specification based on customer / market feedback and input from internal partners (sales, marketing, R&D etc.)
You plan and conduct clinical validations and tests at customer sites
You organize customer sessions and advisory meetings, perform market and competition analysis
You provide support for the elaboration of business plans and the definition of actions to increase product profitability
You hold a university degree in computer science, engineering, medicine or a comparable degree
You have relevant experience in the Medtech industry and in complex development projects or related experience (product management experience preferred)
In-depth knowledge in one or more of the following clinical fields: radiology, neurology, oncology, cardiology or related fields
A strong technical background in medical imaging and deep familiarity with agile development is an advantage
Preferably you also have experience working in cross-functional teams and directly with R&D, marketing and sales
Strong organizational and communication skills involving internal and external partners are mandatory
You have an excellent command of English and a good command of German and you are willing to travel nationally and internationally (about 20%)

Account Manager Clinical Diagnostic Resume Examples & Samples

Solid knowledge in the field of Immunohematology
Excellent written and verbal communication and presentation skills
Ability to produce results while working with multiple projects under tight deadlines
Master in Biology or equivalent
Minimum 5 years proven successful experience in sales and marketing in the Clinical Diagnostics/Life Science industry
Direct line management experience
Proven ability to prepare, implement and monitor business/marketing plans

Senior Manager, Clinical Trials Resume Examples & Samples

Assists sales associates in early discussions with prospective customers to supply insight into how motion biosensors may be deployed and the data analyzed to address the questions of interest
As the opportunity matures, draws on practical knowledge to advance the selling process by advising customers on study design and subject compliance to increase the probability of a successful engagement and data collection
As a study protocol matures, applies practical experience to advise customers on data collection strategies and practical aspects of deployment of motion biosensors in biomedical research for their specific area of inquiry
Consultation on the analysis plan to increase the probability of useful outcomes by selection of useful endpoints
If the analytical needs of the customer are non-standard, assist the operations team on development of methods to process the data to the desired endpoints
Help present and interpret the results of the motion endpoints to the customer, field questions and design further analytical steps if needed
Acts as the scientific advisor to the sales and operations team. Helps interpret complex scientific concepts to enable associates to grow in their expertise

Manager, Clinical Contracting & Outsourcing Resume Examples & Samples

Assist Director in the management of the outsourcing, vendor selection and clinical contracts process
Generate RFPs, RFIs and contract templates
Create and provide budget forecasts for clinical projects
Negotiate and maintain clinical development contracts, including MSAs, CDAs, clinical sites, CROs, central laboratories, consultants and specialty vendors
Work closely with internal teams, including legal, compliance and clinical operations functions in selection and management of vendors and study sites
Manage selection process and develop strong relationships with vendors in conjunction with functional teams
Develop tracking tools (spreadsheets, databases, etc.), attends team meetings as appropriate
Assist in the monthly accrual process and financial reporting for projects
May manage individual contributor/professional employees, or supervisors of employees
Bachelor’s degree with five years of experience or in lieu of a degree a minimum of seven years related experience in the pharmaceutical or biotechnology industry
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Extensive experience generating RFPs, RFIs, and study budget/contract templates
Proven track record negotiating contracts and budgets with international vendors and clinical sites
In-depth knowledge of compliance and legal issues related to the conduct of clinical trials
Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
Ability to prioritize and handle multiple tasks simultaneously
Maintain up to date information on changing healthcare regulations affecting clinical trial payments
Some limited travel may be required

Manager, Clinical Services Resume Examples & Samples

Oversight of the day-to-day operations and staff in the Clinical Services Department: denials & appeals, letter generation, clinical correspondence, data analytic support and clinical training
Works closely with Director of Clinical Services and AVP of clinical Operations to ensure clinical processes and procedures are in alignment with regulations and accreditation standards within each department
Oversight of denials, appeals, and production of letter generation to ensure compliance with all State, Federal, Plan rules, URAC and NCQA requirements.Conduct periodic audits of correspondence in production to ensure continued compliance standards are being met
Responsible for clinical criteria updates, clinical policy and procedure review to ensure compliance with Beacon Corporate Clinical, State, client, regulatory and accreditation standards
Assist Clinical Directors with client and accreditation audit preparation and presentations
Assists Director of Clinical Services with clinical implementation
During implementations coordinates with hiring manager on ensuring infrastructure and training is in place for new hires
3+ years’ experience in Behavioral Health
Experience with Behavioral Health Utilization Review, Case Management and technical operations in a managed care setting is preferred
Project Management experience preferred
Advanced level of PC skills required in Word and Excel

Manager, Clinical Services Resume Examples & Samples

Regimen Profiler
Margin Analyzer
Regimen focused Patient Education materials
New Drug Therapy Information
Pharmacy, Admixture Policies & Procedures

Manager, Clinical Documentation Operations Resume Examples & Samples

Support the embedding and implementation of eTMF and associated systems across Pharma R&D by working directly with Study Teams as they use the eTMF system to ensure inspection readiness throughout the study lifecycle
A subject matter expert and member of a TMF Inspection Readiness Support team that guides study teams preparing for regulatory inspections
Lead the development of high quality end to end process guidelines, best practices and standards focusing on effective and efficient clinical documentation management in collaboration with the other business partners
Analyze business problems/opportunities, develop and deliver high quality solutions that
Support the embedding and capability development for TMF processes and systems across Pharma R&D to ensure inspection readiness of the organisation in partnership with Global Clinical Study Support, LOC Implementation Leads, Functional/TA change leads, Integrated Systems Support and IT
Support business management monitoring activities for the business process owner, harness metrics data in support of decision making and action plans, resolve level-2 escalated tickets, analyse trends to get insights on pain points, technical and training needs
Contribute to the delivery of the Communications & Engagement Schedule providing subject matter expertise and know how, training and learning opportunities for the organisation
Participate in change management and/or process improvement initiatives and/or IT projects analysing business problems/opportunities, develop and deliver high quality solutions that will impact customer groups
Maintain the knowledge centre on the Pharma TMF website (e.g. FAQ, Q&As, Help sheets)
LI-GSK

Manager, Clinical Transformation, Cco-onsite Resume Examples & Samples

Manage initiatives to improve performance of community based CCOs, supporting the team in driving systemic changes necessary to improve quality and lower costs of care
Monitor performance against the regulatory requirements of the program to ensure performance meets contract and customer expectations
Work with internal and external business partners to identify, define and implement opportunities to improve clinical programs and performance through Quality Improvement Methodologies
Evaluate population data trends and outcomes for key indicators, prepare presentations on program outcomes and operations and present to senior executive leaders in Iowa and nationally
Develop and execute strategies for Health Home Program in Iowa as required based on state mandates
Collaborate with CMO and medical directors to ensure team effectiveness in leading Joint Operating Committee meetings with Health Homes in Iowa
Communicate with business partners and stakeholders to share process and outcomes of Health Home operational performance and outcome effectiveness
Provide regular feedback to internal and external business partners to show progress in meeting Health Home and Program wide financial and quality metrics
Meet with internal and external business partners regularly to provide up to date data on clinical performance and guide decision-making
Work with internal and external business partners to gain awareness of all issues and concerns
Attend Health Home JOCs and state meetings as requested by Iowa clinical leaders (e.g., Joint Operations Committees for Health Homes, Health Home Program Manager meetings and Iowa Medicaid Enterprise meetings
Collaborate with Quality team on performance improvement strategies, with Compliance to support external audits as required by contract
Facilitate case conferencing as needed with the entire Health Home Program Manager Staff to ensure that all aspects of the patient plan of care are followed, collaborate with CMO and clinical teams as needed
Review Population updates to identify any avoidable ER visits or Hospital Admissions- 30 day readmissions for Health Home patients and ensure safe care transitions for patients
Troubleshoot solutions with Program Managers on clinical issues that create barriers to care
Establish plans of correction that include interventions and monitor and evaluate outcomes of the corrective action
Consult with hospital teams Health Home Program Managers and practice team for Care Coordination across the population
Use the Accountable Care Population Registry/UHC Care Transitions to monitor care for high risk patients, plan visits, track follow up and ensure open care opportunities are addressed
Participate in clinical team huddles, operations reviews with Transformation Consultant and monthly JOC meetings with community based organizations, practice and hospital leaders to report progress on all clinical activities
Five years or more experience leading clinical teams to improve quality and performance
Five years or more experience working with Iowa community agencies and providers
Experience using data to drive strategies and operations which improve population health
Experience developing workflows and processes to improve outcomes
Understanding of HEDIS quality measurement and outcomes
Medical / Behavioral Health experience
Exceptional computer skills: Excel, PowerPoint, Word and Visio
Must reside in the Des Moines, Iowa area

Senior Manager, Clinical Technology Resume Examples & Samples

When necessary, implements necessary performance improvement plans. Is responsible to identify any issues where coordination and integration of systems is required to ensure the proper functionality of the technology. Assures that all Clinical Technology Plan efforts are managed and tracked by appropriate financial systems and controls
Continually evaluates the cost/benefit of service alternatives (e.g., in-sourcing and out-sourcing). When external resources are used, this role is responsible for ensuring that they are used effectively, and meet the cost/quality and compliance standards of the program. Ensures that technology integration plans have sufficient level of detail so technical, financial, environmental, operational, regulatory/legal, and maintenance/support aspects are defined, scoped and understood by the project management teams who will execute against these plans
Professional certification as a Certified Clinical Engineer preferred

Manager, Clinical Applications, ANZ Resume Examples & Samples

Alignment of CAS field execution and training programs with applicable business strategy
Ongoing certification/recertification for self to ensure clinical and technical expertise to support field-level CAS management and identification of gaps or deficits
Ongoing certification/recertification of direct reports to ensure competence
Seemless account level coordination/collaboration in compliance with stated corporate guidelines
Maintain active field shadowing and coaching with direct reports in addition to regular one:one monthly calls
Reinforcement of appropriate deployment, roles and responsibilities of CAS Direct reports
Execution of CAS activities in the geography, as per CAS strategies and formal KPIs
Adherence to safety and regulatory compliance requirements as per local and other relevant legislation and Alcon policies
Recruitment, development, and retention of Top Talent in the Region
Thorough understanding of medical device regulations
Demonstrated communication skills (oral and written)

Manager, Clinical Solutions Resume Examples & Samples

Provides leadership on activities related to the department's technology services and defines and enforces Corporate IT Standard
Communicates appropriate corporate compliance standards and procedures for all department employees
Provides supervision and administration duties including hiring and firing, performance reviews and evaluations, staff counseling, etc. for the department
Four years in a supervisory/management capacity
Additional progressively responsible IT experience may substitute for the degree requirement
Experience with financial budget planning, managing, analysis and reporting
Experience in software development, program development, and clinical applications important to job success
This role is focused on resource management for the team
This individual will be cross trained on different functions to build a successful team
Epic knowledge preferred

Manager, Clinical Services Resume Examples & Samples

Reflects the skills, knowledge and abilities that individuals use as they serve in the role of a leader. The following provides examples of specific behaviors that correspond with Mercy and Trinity Health leadership competencies
Maintains a working knowledge of applicable Federal, State and local laws and regulations, the Organizational Integrity Program, Code of Ethics, as well as other policies and procedures
Makes decisions based on knowledge, experience and the ability to forecast using information management and relevant data
5 Shows mastery of job content, demonstrates skill and knowledge of individual profession and area of responsibility. Keeps current with new trends and developments and seeks out continuous education for management skills
Promotes practices to maintain an efficient and effective work force through staffing model development, recruitment, selection, training Recognizing patient needs, and competence of the staff, gives employees appropriately challenging assignments
Recognizing patient needs, and competence of the staff, gives employees appropriately challenging assignments
Establishes and communicates employee performance expectations, assesses staff competencies and actively participates in the planning and implementation of staff development processes and activities
Provides leadership and promotes staff involvement in continuous quality improvement activities. Conducts on-going quality management by identifying quality assurance issues and coordinating action and follow-up. Spots problems, opportunities, threats and trends early
Ensures risk management principles and practices are implemented. Establishes and\or ensures staff adherence to standards and regulatory agency requirements
Monitors documentation to ensure compliance with Mercy Medical Center policies and procedures
Monitors the educational needs of staff. Provides for programs designed to meet the education needs
Practices participative management; shares responsibility and influence
Facilitates the development of working relationships, which enhance team and individual performance to achieve best practice
Is open and maintains a non-defensive leadership style and is receptive to constructive suggestions. Aware of her/his feelings and makes needed adjustments in own behavior
Confronts others skillfully, applying policies consistently and fairly. Evaluates and disciplines employees as needed and notifies Department Director and/or other areas of authority as necessary
Negotiates adeptly with individuals and groups over roles and resources. Is a team builder; brings people together successfully around tasks
Collaborates and fosters positive professional relations with medical staff
Develops a network of contacts (internal and external), and works well with other departments/units as well as within the community. Builds cooperative working relationships
Participates actively on committees and disseminates information appropriately. Is action oriented/goal directed, and seeks results
Demonstrates understanding of patient care and its issues and represents the nursing profession to others
Schedules and assigns employees to ensure adequate staffing within budgetary guidelines and provides justification for over variance
Directs and ensures the maintenance of equipment and supplies on the unit. Submits requests for additional supplies or equipment following established procedure
Familiar with third party reimbursement policies and trends, in order to optimize customer service and coordination of resources across the continuum of care
Ensures the confidentiality of information pertaining to patients, physicians, employees and visitors is maintained
Is responsible for creating an environment of organizational learning about patient safety and medical/health care error reduction, supports sharing of knowledge, and fosters behavioral changes to improve patient safety
Demonstrates the knowledge and skills necessary to provide service/care appropriate to the age of the patients served, in
Demonstrates general working knowledge of computers and department specific software (i.e. Healthstream, internet, etc.)

Finance Manager, Clinical Genomics Group Resume Examples & Samples

Maximize long-term shareholder value while protecting corporate assets
Help drive the Clinical Genomics Group (CGG) quarterly rolling forecast and annual budget expense planning processes (project and BU/functional budgets)
Interact with Clinical Genomics Business Unit (CGG) leadership teams to provide financial support, analysis, and coordination for business planning initiatives in support of corresponding BU’s and functions
Lead the analytics around the clinical product portfolio, including budget management, ROI analyses, product life cycle management and balanced portfolio optimization initiatives
Liaise and build rapport with market development, product marketing and project managements teams to gain insight into portfolio roadmaps and strategies
Analyze, synthesize and translate data into key strategic inputs and insights that will drive decision making at the executive level
Develop financial models and analyses to support strategic initiatives
Support monthly/quarterly close process as it pertains to operating expense management, general ledger reviews, headcount reviews, accruals, and other related processes
Act as a functional expert on various Illumina financial and other key systems (i.e., SAP, TM1, Cognos BI)
Acquire intense understanding of Illumina’s business today, and critical insights into where it is going in the future allowing for innovative concepts and the promotion of new ideas

Manager, Clinical Consulting Resume Examples & Samples

Assess effectiveness of Clinical Team and develop plans to improve skills needed to increase account coverage, development and expansion opportunities
Communicate success, tips and techniques of successful tactical execution of programs; participates in distribution of clinical information to Clinical Consultants and sales team
Conduct regular Clinical team communication to track progress, assess challenges and redirect as needed to drive Haemonetics results
Develop strong relationships with thought leaders and influential opinion leaders within the industry
Ensure Clinical Team is effectively meeting customer, territory and region needs as it pertains to applicable Haemonetics product lines
Execute strategy developed by Business Leaders to ensure successful product utilization and drive increased revenue to achieve sales results
Mentor Clinical Team to develop tactics and strategies to establish Haemonetics products as Standard of Care
Participate in and assist in the development of clinical strategies in conjunction with cross functional areas such as marketing, sales, implementation services, etc
Participate in the planning process by partnering with sales and marketing with such initiatives as Customer Acceptance Trials, Limited Market Releases and clinical/training aspects of new product launches
Maintain up to date knowledge in the applications of existing, new and competitive products
Serve as a communication channel for field organization and corporate partners ensuring that feedback from Clinical Team is timely and identifies needs or opportunities to increase effectiveness & revenue
Identify and assist in implementation of additional training as needed based on customer and employee feedback

Manager, Clinical Trials Set-up Resume Examples & Samples

This position involves extensive mentoring and professional development of direct staff within the Customer Delivery Teams
Strong people management skills with the ability to develop and lead cross-functional teams
Excellent interpersonal, organizational and client management skills
Direct line management experience preferred
Strong knowledge of Project Management processes, Q2 Solutions Laboratory processes, and/or equivalent working knowledge of central laboratory operations preferred
Demonstrated computer proficiency with Microsoft Office and Q2 Solutions systems, or equivalent experience with similar Centralized Laboratory systems preferred
Experience in successfully leading large, global and complex Phase I-IV clinical trials preferred
Demonstrated ability to work in a fast-paced while possessing strong organizational skills and an ability to meet deadlines
Strong written/verbal communication skills including good command of the English language. In certain geographies where local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred
Bachelor's degree in Life Sciences and/or related field preferred
5-7 years of experience in clinical trials/ hospital-funded research, project management or laboratory environment preferred

Product Manager Clinical Chemistry Resume Examples & Samples

Develop a marketing plan for specific activities based on local market conditions and consistent with the international, regional Marketing Plan
Provide to Clinical Segment Sales team, all activities and materials relevant to the promotional strategies and tactics of Clinical Chemistry products
Manage new and existing products in regards to packaging, local registration, performance & evaluation, international forecasting, changes and pre-launch training needs
Communicate pricing changes to all customers and distributors
Achieve the sales target set for Clinical Chemistry products

100

Manager Clinical Field Operations Resume Examples & Samples

Manages, supports and trains CRAs/LCRAs/CIS on SOPs, documents and internal processes
Manages, leads and motivates CRAs/LCRAs/CIS
Provides support to the clinical team in the conduct of the trials
Arranges and performs periodic co-monitoring visits with CRAs
Reviews and finalizes with project team trial related documents
Participates actively to project team meetings, as required
Supports CRAs/LCRAs/CIS to be Audit ready for internal, external and site Audits
Close collaboration with internal stakeholders to ensure proper project conduct
Identifies and supports process improvement opportunities and implementation
Attends live cases minimum twice a year
Actively monitors CRA and LCRA and CIS headcount needs
Contract negotiation and finalization with external providers
Master’s degree or PhD in a Scientific Discipline- Biomedical Engineer preferred
Good English skills (written & spoken)
Computer skills – Microsoft Office
Required a minimum of 10 years of clinical research experience
Clinical trial management experience required in medical devices
Experience in cardiovascular surgery and/or interventional cardiology
Ability to understand and interpret medical and scientific data
Strong interpersonal skills are required. Must have demonstrated skills in the following areas: leadership, coaching, counseling and strategic clinical trial planning
Effectively work with and lead cross functional teams
Experience with resource allocation and vendor management
Knowledge of European and international regulations and guidelines

101

Senior Manager, Clinical Affairs Resume Examples & Samples

Ensure on time execution of all TMTT clinical trials and related activities are achieved per annual operating plan in accordance with global clinical processes, regulations and good clinical practices
Responsible for operations teams including senior managers, contracts manager, clinical research associates, and administrative staff
Ensure study compliance via internal and external monitoring, in accordance with regulatory and corporate/divisional requirements
Ensure the management and maintenance of site and internal research documentation are handled in accordance with established Standard Operating Procedures (SOP´s) 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
Maintain regular contact with partner TMTT clinical teams for the exchange of study related information
Ensures the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards’ research programs
Participate in the development of divisional and regional research strategies and plan. Network appropriately with relevant stakeholders
Education: advanced degree in medical, or biological sciences highly preferred
More than 10 years managing clinical studies or related clinical programs preferably on cardiovascular medical devices
Experience in clinical, regulatory and marketing aspects of medical device technology
Supervision or mentoring of subordinates
Ability to effectively lead and manage a diverse team
References addressing quality of relationships and collaborations
Knowledge of basic biostatistical and actuarial methods
Familiarity with hospital environment
Thorough, conscientious and results oriented working style
Team oriented
Able to forecast and manage large research budgets

102

Account Manager Clinical Resume Examples & Samples

Possess BS or BA degree in Medical Technology, Microbiology, Life Science or Business major or equivalent experience
Works independently and in a self directed manner
Ability to gain consensus and work as part of a team; brings all resources together to successfully develop new business and maintain existing business
Strong presentation skills required

103

Manager, Clinical Ancillary Solutions Resume Examples & Samples

Creates and manages global clinical ancillary management sourcing solutions strategies to ensure ancillaries can be successfully procured and distributed globally. Leverages Thermo Fisher Scientific products, relationships, and our global distribution network in order to drive continuity of supply to the patients we serve and maximizes the profit potential for goods purchased
Understands and employs understanding of clinical trial protocols and customer requirements to develop sound recommendations and identify potential areas of concern with ancillary products and projects to allow for proactive troubleshooting
Manages the team that triages solutions, identifies the appropriate product, creates the distribution strategy, works to obtain pricing and ultimately requests the quote to return to the client
Serves as a subject matter expert on the Clinical Ancillary Management (CAM) service line and is instrumental in leading team efforts in support of positioning the service offering in the market place
Partners with Sales, Clinical Supply Chain Managers, Quotations and Materials Management to develop optimal solutions and satisfy customer requirements
Facilitates customer conference calls and interfaces with key stakeholders, including CROs, on a regular basis to identify and address needs as well as keep all parties informed of the status of study materials and supplies
Utilizes Practical Process Improvement (PPI) tools to lead and participate in projects targeted at process improvement within both the Solutions and the overall Ancillary Management team
Leads harmonization and process improvement initiatives in partnership with the Global Director of Clinical Ancillary Management to globalize the Solutions team and ensure all involved facilities are following the same processes
Utilizes salesforce.com, SharePoint, and Microsoft Office to track, monitor and implement global sourcing initiatives
Creates service line visibility, value differentiation and growth by partnering with the divisional marketing team to develop marketing content
Provides ongoing coaching and development support for team of Clinical Ancillary Management Solutions Team
Administers the Performance Management Development process for team members including mid- year and year-end performance discussions on time per company guidelines
Develops standards for employee and department performance in partnership with the Global Director of Clinical Ancillary Management
Holds staff accountable for their ongoing performance, acknowledges exemplary behaviors and implements progressive discipline, if necessary
Monitors and tracks training requirements of all direct reports utilizing corporate training database (iComply)
Conducts regular team meetings to assess the status of projects, identifies necessary resources, and proactively addresses issues
Performs day to day management of assigned CAM team personnel and project oversight
Maintains appropriate metrics to ensure business success
Responsible for budgetary aspects including personnel expenses, and other related costs
Works closely with the CAM leadership to ensure best practices, training and procedural aspects are aligned globally
Works with Fisher Clinical Services Clients, Clinical Supply Chain Managers, Program Managers and the FCS sales force to understand the supply chain requirements to support Clinical Trials
Demonstrates the ability to promote the company vision
Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the growth of the businesses
Represents and appropriately positions the services for potential clients
Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to develop new or improve existing business processes and appropriately document and revise or develop associated training materials
Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned
Models and foster excellent customer service (internal and external) in all functions and responsibilities
Models Thermo Fisher Role Model Leadership competencies in all interactions
Identifies resource needs and hires when people are needed
Direct experience in the ancillary, lab supplies or CRO industries with drug development and/or clinical supply services preferred
Superior analytical skills and problem solving abilities
Sound administrative skills and well developed management methods with proven ability to motivate personnel
Must be a results oriented individual with the ability to work cross functionally and with diverse populations

104

Manager Clinical Svcs-hospice Resume Examples & Samples

BSN or equivalent with 5-10 years clinical experience
Two years of hospice experience
1-3 years of management experience
Computer experience with Word or like programs
Participates in managerial on-call rotation
May require excessive hours during development, implementation or expansion of hospice programs
May be called upon to do patient visits as needed
May travel frequently among hospice care locations
Will carry a pager
Management/coordination of clinical and therapeutic hospice services to assure appropriate quality care and timely reimbursement from third party payors
Maintains costs within budget of cost center
Responsible for achievement of agency, department and personal goals and objectives
Provides expertise to staff regarding clinical situations, quality of documentation, third party payor guidelines and policies and procedures
Responsible for quality and timely clinical documentation

105

Manager Clinical Resume Examples & Samples

4 hours or equivalent education activities of the annual CEUs shall be related to cerebrovascular disease
Good customer orientation
Planning and delegation skills
Basic team building skills
Utilization of critical thinking in timely decision making
Ability to prioritize and respond to multiple simultaneous request
May be exposed to hazardous materials and life-threatening diseases
Maintains effective working relations with both internal and external customers
Prepares of departmental budgets (supplies, equipment, personnel)
Responsible for budget management and performance and fiscal oversight of all areas of responsibility

106

Senior Manager, Clinical Development Resume Examples & Samples

Providing a clinical review of study-specific documentation and training materials
Assessing reported protocol deviations
Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team

107

Senior Manager, Clinical Oustourcing Resume Examples & Samples

BA/BS degree in life sciences, business, Finance, or equivalent
6+ years in pharmaceutical industry; 4+ years outsourcing
MBA/MA, 2+ years in the pharmaceutical industry; 2+ years outsourcing

108

Product Manager Clinical Solutions Reference Products Dach Resume Examples & Samples

Market research (customer needs and readiness, competitors, macro drivers) for reference products
Define product localization requirements based on market insights and makes sure these end up on the development roadmap
Coordinate product localization IDS and reference products (content development and integration)
Support segment marketing to sharpen value proposition, drive awareness and acquire leads
Further extend/ sharpen Elsevier's thought leadership in the field of Clinical Decision Support in DACH and EE
Organize own events and present at other industry events (write and submit papers etc.) to drive awareness of reference products
Acquire, implement and evaluate pilot projects for reference products
Support sales team to identify, prepare, lead and close sales opportunities (incl. on-site customer visits)
Build up and deepen relationships and cooperation with HER vendors
Deliver revenues

109

Case Manager Clinical Team Lead Resume Examples & Samples

Leads the Case Management Team by directing the activities of team members, drawing upon referral criteria and clinical expertise to manage all aspects of Case Management
Assists with the design, development, modification, of workflows for the Case Management Team
Supports the development of solutions for issues and presents recommendations to the Clinical Manager and/or Clinical Director
Assist in establishes goals and objectives for the CM Team and individual team member roles and responsibilities
Possesses and maintains in-depth knowledge of workflows, products, program components
Troubleshoots for problems and submits recommendations. May be required to interface with other areas, either internally or externally, to effectively resolve problems
May provide direct supervision of staff, including performance reviews
Work collaboratively to coordinate a supportive environment and clear communication
Maintaining accurate information in Beacon’s clinical documentation systems as directed
Developing or overseeing a plan of care for each assigned member, adhering to timelines and including assessment of health needs, individualized care management plans, implementation, monitoring and evaluation of care outcomes
Assist with NCQA and URAC initiatives
Urgent calls
Attend Clinical meetings
Demonstrated work experience to influence and negotiate to effectively manage patient care and health care outcomes
Demonstrated work experience meeting strict deadlines and established cycle times through effective prioritization and follow-up
Educated in current principles and procedures of behavior health care.Knowledge of managed care and state specific expertise preferred
Strong interpersonal skills and good written and verbal communication skills
Advanced computer skills required, including working knowledge of MS Office: Word, Excel, and PowerPoint

110

Manager, Clinical Studies Resume Examples & Samples

Recruit, hire, train, manage Clinical Research staff and their career development
Select Clinical Research consultants and Clinical Research Organizations (CROs) and manage their contracts
Prepare and track Clinical Research budget
Allocate resources and budgets to various department projects and oversee their progress
Participate in preparation of Clinical Research operating plans and objectives in alignment with company and department strategies
Supervise the implementation of clinical programs and track their progress
Oversee the planning of new clinical programs and the development of clinical protocols
Review and approve submissions of protocols and reports to FDA and Institutional Review Boards (IRBs)
Interact with Investigators and IRBs on financial and compliance issues
Collaborate with Clinical Operations Manager to establish effective and efficient intra-departmental processes
Oversee the proper collection, analysis and presentation of clinical data
Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases
Oversee development and maintenance of department SOPs
Assure compliance of department activities to FDA regulations, department SOPs, and other regulations
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Spine's Business Process Excellence initiative

111

Manager, Clinical Trial Resume Examples & Samples

The incumbent ensures the assigned clinical study(ies) is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures
The incumbent will be responsible for all regional study management aspects of a clinical study including but not limited to all the tasks specified below. For all the regional study activities in a global study, the incumbent will work with the OSL to ensure regional activities support the timelines of the global study. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Clinical Trial Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team
Understand technical, scientific and medical information
Handle conflict management and resolution
Understand clinical study budget
Previous experience of site monitoring and study management preferred

112

Account Manager, Clinical Diagnostics Resume Examples & Samples

Good organisation and planning skills
Demonstrated initiative and proactive approach/ results driven
High level computer literacy and extensive software usage
Current driver’s license
Demonstrated ability to work successfully in a team
Proven ability to work under pressure
Persistence & perseverance
Tertiary qualifications (BSc) preferably with Clinical Diagnostic experience
Previous relevant laboratory experience
Previous sales experience in the Clinical Diagnostic Industry
Marketing / Business qualifications
Membership of relevant associations and learned societies

113

Manager, Clinical Development Resume Examples & Samples

Provide screening tools and metrics to R&D teams and physicians for patient evaluation for a given technology
Provide clinical science support for the Regulatory Affairs during their interactions with agencies
Maintain regular contact with Marketing, Clinical affairs, and the R&D Organization for the exchange of study related information and its impact on project strategy
Develop with cross functional teams procedural instructions for use and training materials for FIH and early-stage clinical studies
Provide scientific and clinical support for R&D technical summaries and other design control documents
Maintain awareness of relevant medical and scientific published findings in the target fields as they occur

114

Senior Manager, Clinical Trial Resume Examples & Samples

The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all the tasks specified below. For all the global study activities, the incumbent will work with the Regional CTM(s) to ensure correlation of global study activities. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Clinical Trial Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team. If a Corrective and Preventive Action is put in place, the incumbent may be asked to serve as the CAPA Lead
Handle and prioritize multiple tasks simultaneously
Work effectively in a team/matrix environment
Understand clinical study budgets
Plan, organize, project manage and analyze data
Demonstrate full competency in Microsoft Office programs

115

Manager, Clinical Information Systems Resume Examples & Samples

Directs and manages CIA teammates
Acts as an integral part of the Information Services Department leadership team
Works closely with the Medical Directors to establish and maintain good working relationships
Represents the IS department in appropriate work group, teams, committees and meetings
Oversees the technology, change management vendor management and contract management
Conducts various types of meetings with physicians and/or representatives from their offices
Ensures that appropriate documentation exists for all applications, processes, policies and deliverables
Directs staff in the efficient and thorough completion of work related tasks
Establishes clear expectations for all personnel reporting to this position
Works with IS management to establish and maintain proper staffing levels
Manages deliverables within budget
Excellent verbal, written and presentation skills
Strong people skills

116

Manager Clinical Engineering Resume Examples & Samples

Performs staff performance evaluations and training activities, and assists with capacity planning for staff and contract labor
Ensures that equipment is maintained, secured, renovated, and deployed according to departmental/organizational policies, procedures, plans and initiatives
Assists with the development of and compliance with the departmental budgets, including capital, operating and construction budgets
Maintains knowledge of applicable statutory, regulatory and administrative requirements and ensures departmental compliance
Leads projects and initiatives within the work group
Minimum of 5 years of clinical/medical engineering experience
Must include extensive experience in assigned area of specialization and leadership experience

117

Manager Clinical Quality Resume Examples & Samples

Case management and coordination of care
Takes lead role in setting direction and participating in or developing new programs
Current, unrestricted RN license in the State
3+ years experience as a manager
3+ years experience in a hospital setting, acute care, direct care experience or experience as a telephonic Case Manager for an insurance company
Experience in utilization management, utilization review, concurrent review and/or risk management
Clinical data analysis and reporting
Leading clinical quality initiatives

118

Senior Manager Clinical Application & Standards Resume Examples & Samples

BA / BS Computer Science/Information Technology of Life Sciences from a 4 year accredited university or equivalent experience
Clinical programming experience is required
Proficient computer skills across multiple applications
Minimum 8 years clinical database programming experience preferred in the device / pharmaceutical / CRO industry
Minimum 4 years database programming experience designing studies and data validation programming in EDC required; RAVE/Medidata Solutions preferred
Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
Expertise with reporting tools; J-Review, SAS, and/or Spotfire are preferred
PL/SQL, SQL scripting experience required; understanding of relational databases
Knowledge of industry standards; CDISC-SDTM/CDASH preferred
Experience with external data handling of study data preferred
Experience with clinical dictionaries; Thesaurus Management System (TMS), MedDRA and
WHO dictionaries are preferred
Proficient understanding of system administration to effectively interact with the tools and/or
Database administrators

119

Manager Clinical Services Resume Examples & Samples

Provides direct day to day supervision of staff including licensed and unlicensed staff
Preparation for case review meetings including health plan specific reviews as directed by Director of IP Management
Acute and SNF Inpatient management (reviews, denials, transfers)
Oversight of discharge planning
Works directly with hospitalists to facilitate appropriate length of stay and resolution of specialist issues
Provide ongoing educational opportunities to staff, ensuring an understanding of the business processes, technology used within the organization, regulatory compliance, program standards and outcomes
Preparation of inpatient denial letters including DENC as required
Assists with health plan audits and surveys
Develops and implements new policies and procedures
Orients / trains case management staff on case management processes and identifies efficiencies and develops / facilitates corrective action plans
Participates in IPA UMC Meetings and Provider Office Meetings as assigned
Current unrestricted RN licensure in the state of CA
2+ years of experience preferably in the managed environment
Knowledge of Case Management, Utilization Management and Quality Management processes and principles
Previous management and / or training experience
Complex Case Management experience
CCM - Professional Certification or License

120

Manager, Clinical Documentation Resume Examples & Samples

Assists in developing processes and tools for use by the Clinical Documentation Improvement Specialist team to include communication processes with the coding department and physician staff
Teaches Clinical Documentation Improvement Specialists clinical documentation improvement techniques, processes and tools
Assist the CDIS Director monitor the quantity and quality of work performed by the Clinical Documentation Improvement Specialist team
Assist with developing educational and training materials on clinical documentation improvement for CDIS training as well as routine education of medical staff, residents, physician extenders, nursing, ancillary personnel, case managers and others
Provides routine educational programs to the medical staff, residents, physician extenders, nursing, ancillary personnel, Case Management and others on a routine basis to promote the concepts of clinical documentation improvement
Serves as primary liaison with medical staff regarding documentation, reimbursement, and clinical issues
Assist the CDIS staff with reconciliation processes
The Lead Clinical Documentation Specialist will document relevant trends of inaccurate coding and areas that are high risk for compliance issues and prepare written reports summarizing audit findings and, making recommendations for improvement and correction where identified
Participates in the analysis and trending of statistical data for specified patient population to identify opportunities for improvement
Assist with chart reviews as needed
Facilitates and collaborates with physicians on the resolution of all post discharge queries prior to data submission to St Paul deadline
Excellent interpersonal skills to build partnering relationships with physicians and Healthcare team to resolve physician queries for final coding identified after patient discharge
Assist with performance improvement projects to identify key drivers for selected populations and/or evaluate trends of concern
Works effectively with the Coding Manager/Coding Auditor to improve coding services provided by the coding staff
Possesses knowledge of APR-DRG,POA,MHAC and grouping methodologies; in particular what diagnoses / procedures
Assist CDIS Director conduct performance improvement projects to improve the capture of clinical documentation and/or coding for specific populations to include
Data analysis
Participates on the Organizational Committees to
Present analysis of CDIS and query processes (CDIS/coder)
Lead performance improvement initiatives to improve clinical documentation and/or coding
Provides vacation coverage for CDS assignments
Graduate from an accredited school of nursing with Associates Degree in Nursing or related discipline
Current licensure as a Registered Nurse in Maryland or compact state
Minimum three (3) years medical-surgical, critical care/acute nursing experience or three (3) years as a Clinical Document Specialist
Must be conversant in 3M or similar encoder software, Midas, Cerner EHR
Working knowledge of ICD 10 & PCS, APR-DRGs

121

Program Manager, Clinical Trials Resume Examples & Samples

Provides a strategic vision and leadership for the Clinical Trials Program
Leads an extensive program of work including the allocation of resources to achieve the specified outcomes of the NSW Cancer Plan
Evaluates and looks to continuously improve the Institute’s cancer clinical trials program
Fosters collaborations with key external stakeholders including with industry to share knowledge and promote NSW as the destination of choice for cancer clinical trials
How your experience in managing clinical trials can be used to inform and influence how limited resources should be utilised to make NSW attractive for clinical trial sponsors
What you consider are critical external factors that may impact the Institute’s cancer clinical trials program

122

Manager, Clinical Data Operations, Pragmatic Resume Examples & Samples

Knowledge of project management techniques and tools
Project Management Professional certification desirable
Proven experience in risk and change management
Familiarity with process definition and improvement methodologies and experience in managing process improvement initiatives desirable
Familiarity with SAS and RDBMS tools, including analytics and visualization software, is desirable
Experience with vendor management is desirable
Strong planning and organizational skills
Ability to manage multiple projects concurrently and to independently set and communicate priorities
Strong leadership, negotiation and conflict management skills

123

Account Manager Clinical Diagnostics Resume Examples & Samples

Area: Western Germany (NRW, Hessen)
Resolves customer problems or concerns and provide potential and existing customers with written quotations
Along with his/her account team, builds a basic territory plan that consists of account and major product goals. Content should include major strategies, tactics and timelines
Monitors and evaluates competitive services, pricing and other activities
Strong analytical skills to analyze territory data and technical information
Ability to operate effectively with diverse professionals in a team environment

124

Senior Manager Clinical Development Quality Oversight Resume Examples & Samples

University degree or equivalent in Life Science area
At least 8 years’ experience in the Pharmaceutical/biotech and/or contract research organization
Experience and expert knowledge in the development process of new vaccines or other pharmaceuticals, preferable by having worked in different areas such as clinical development, clinical QA, technology development, project management or regulatory affairs
Experience and/or trained in project management
Clear understanding of GCP regulations and knowledge of international and national regulations
Excellent communication and interpersonal skills are required to operate in a constantly expanding and changing environment
Strong ability to work in matrix organization
Excellent PC skills and good written and verbal communication
Takes a lead role to support operational unit in issue / deviations investigation of quality events detected during e.g. monitoring and data management, to identify root causes and corrective actions
Main point of contact for Regional Quality Managers as it related to GCP non-compliance
Ensure issues are appropriately escalated as per GSK global policies and processes; provide support to the clinical team and relevant functions on proper identification and escalation of quality related issues
Champions areas where process improvement can be made, and ensures that linkages to other strategic projects are not overlooked
Support the creation, tracking and communication of quality plans in R&D as appropriate
May facilitate in the closure of CAPAs from any source using established quality DB in collaboration with the CQA CAPA team
Stays abreast of current quality and compliance regulations and guidelines. Support the implementation of a global system for distribution of regulatory compliance training programs in CQA
Represent Quality for R&D and presents at GCP lessons learned, GCP forums as necessary
Serve as the main point of contact for inspection preparation, for both national and local inspections (FDA, EMA, MHRA, etc.) to provide oversight and information on known Quality issues and identification of GCP compliance risks
Support and work closely with all areas of Q4RD in the achievement of the missions and objectives of the department

125

Manager, Clinical Review & Recovery Resume Examples & Samples

Manages the review and analyses of clinical coding and medical policies and procedures and how they impact claim payments
Manages Clinical Review & Recovery Analysts to improve the quality and oversight of the clinical coding and claims payment auditing program
Monitors all department specific data reports, outcome analysis and resource allocation
Creates audit programs that identify issues with medical spending, recommends and implements cost saving methodologies
Manages vendor relationships specific to clinical coding and claims payment audits
Creates and maintains policies and procedures to be followed in all clinical coding and claims payment audits by both internal staff and recovery vendors
Monitors production data to stay abreast of trends and alters the direction of audits accordingly
Bachelor’s degree in Nursing, Healthcare Administration or similar field
8 years progressive experience in health insurance operations, 3 years which are in a supervisory or project management capacity
3 years of experience in clinical coding and claims payment auditing
Registered Nurse with current license required
Certified Professional Coder (CPC) or similar designation preferred
Certified Professional Medical Auditor (CPMA) preferred
Registered Health Information Administrator/Technologist (RHIA/RHIT) preferred
Comprehensive knowledge of all facets of claims, medical procedures, terminology and payment analysis and the ability to apply concepts to claim payment processes and auditing programs
Strong Microsoft Office and health insurance operations systems skills

126

Manager Clinical Quality Resume Examples & Samples

Oversees the implementation of plan quality improvement program
Works to coordinate the work within C&S Quality in order to improve HEDIS performance and to close gaps in care
Manages Quality Playbook and work plan programs and activities
Continuously monitors HEDIS and state performance measure results and adjust programs to insure meeting targeted goals
Interviews, hires, and supervises quality department staff
Oversee HEDIS data collection process and annual state performance measure collection process
RN with an active DE license
Minimum of 3 years of leadership (people leadership with direct reports)
Comprehensive understanding of program analysis and action planning
Understanding of HEDIS including technical specifications and 'chart chases'
Understanding of State Performance measures
Experience managing nurses and clerical personnel

127

Account Manager, Clinical Engineering Resume Examples & Samples

Oversees operations of Clinical Engineering Department by: conducting quarterly department head visits and meetings; ensuring that client reports are delivered in a timely manner; providing a working environment that meets all OSHA guidelines; and completing and maintaining all performance indicators at or above program targets
Ensures financial performance of department by: conducting regular department head visits and meetings to review performance of Clinical Engineering program; maintaining PM/CM completion at or above expectations; being actively involved in capital asset planning, purchasing, etc., and other committees as assigned; conducting customer satisfaction surveys as required
Ensures CHI financial performance by: attaining all expense budgets and cost containment targets; ensuring that expenditure authority and level are adhered to; and forwarding, in a timely manner, all appropriate PO’s, invoices and financial details to the appropriate sources
Manages and oversees technical personnel recruitment, training and development. This includes holding all necessary staff meetings; training technical staff; providing written measurable objectives; coordinating vacation, sick days etc.; and performing midyear and annual performance evaluations
Ensures smooth communications and reporting to and from each account as applicable. This includes conducting all necessary meetings with facility administration, and forwarding all positive and negative customer/vendor communications to designated supervisor for review
Provides professional team and personal growth that meets the needs of the customer and employees
Networks with peers to gain innovative ideas and sourcing of information
Grows the program by gaining the confidence of clinical department heads and maintaining positive relationships
Associate’s Degree in a related field required
At least five years of experience as a senior/lead technician
Must have financial management skills
Must have working knowledge of all elements of CHI National CE Program and/or industry standard clinical engineering management
Reverence: Having a profound spirit of awe and respect for all creation, shaping relationships to self, to one another and to God and acknowledging that we hold in trust all that has been given to us
Excellence: Outstanding achievement, merit, virtue; continually surpassing standards to achieve/maintain quality

128

Manager, Clinical Affairs Resume Examples & Samples

May manage CRAs, Contract Research Organizations, Consultants and administrative personnel
Assess staff performance while providing coaching, feedback and leadership to direct reports
Develop, implement and collaborate on training for company operating procedures, GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements, process improvement as well as training and proctoring new employees on trial and study related activities
Participate in study management activities (prepare reports, provide input on Case Report Form development, develop study materials)
Communicate personnel issues to upper management
Propose corrective actions and contingency plans
Participate in routine management meetings
Periodic in-field assessment and coaching of CRAs at their clinical sites
Collaborate with the development of the monitoring plans and ensure CRA compliance
Partner with Study Managers for each respective study to ensure clinical trial milestones and deliverables are met
Lead discussions and facilitate presentations at Investigator and Clinical Research Coordinator meetings
Collaborates with Lead CRAs to collect feedback and information related to monitoring visit reports, site report cards and dashboards for ongoing management of site issues; such as screening/enrollment, device accountability, site data entry, protocol deviations and outstanding queries
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas required. Must have previous managerial experience of clinical projects and people. Medical device experience highly preferred
A bachelor's degree in a scientific or related discipline required with a minimum of eight years of clinical experience. An advanced degree in a related discipline and/or Professional Health Science certification or designation preferred
Requires a broad cross-functional team experience
Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills
A comprehensive record of delivering research informtion which adds value to management decision making process
Demonstrate ability to understand and comply with all current applicable regulations including CFR 820, Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485, Good Clinical Practice(GCP) and Company operating procedures, processes, policies, and tasks
Advanced personal computer skills including spreadsheet, word processing, database management, power point and other necessary applications preferred
Experience with CTMS and electronic document management systems a definite plus

129

Senior Manager Clinical Outsourcing Resume Examples & Samples

Proactively manage outsourcing contracting activities across functions as appropriate, ensuring adherence to the outsourcing strategy, and company policies and procedures
Develop and maintain a system for tracking progress and status of clinical contracts
Lead sourcing strategies development for assigned clinical categories by applying strategic sourcing/category management tools & processes
Partners with department Managers and Quality Management to ensure providers continue to meet OPDC expectations
Ensures vendors of outsourced clinical trials activities meet OPDC quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations. Modify and update SOPs and WPs and supporting processes and documents as appropriate
Benchmarks with industry peers and across other industries to establish and update best practices for sourcing, contracting and cost efficiencies
Assures that standardized contracting practices are implemented and maintained across all relevant providers
Provides training and communications to internal stakeholders and providers regarding contracting process, sourcing best practices and process improvements
Ensures that expectations within and between the organizations with regard to establishing costs, budgeting and reporting, invoicing, turnaround times, contractual documentation and approach, payment schedules and other business practices are established and managed
Tracks and reports on negotiated savings achieved. Ensures that all business contractual benefits are obtained
BA/BS in Life Science, Finance, or related field
5+ years pharmaceutical/biotechnology experience
Working knowledge of associated disciplines including Clinical Trials Management / Operations, Clinical Monitoring, Data Management, Safety Reporting, Medical Writing, Regulatory, and Ancillary Vendor Services
Broad and deep understanding of Contracts and Outsourcing practices for Global Clinical Trials, including current legal, regulatory, GXP, EQC and SOX, components of the process
Ability to provide direction with cross-functional teams in a team environment, collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
Ability to enact change and foster an innovative atmosphere
Demonstrated negotiation skills/ strategies

130

Manager, Clinical Reimbursement Resume Examples & Samples

Coordinates coding and reimbursement tasks for reduced days in accounts receivable
Identifies and resolves issues from other departments related to coding, denials, and appeals
Reviews DRG assignment for Medicare/Medicaid and commercial patients for the purpose of reimbursement, research and statistics in compliance with Federal regulations according to ICD-9-CM, and CPT-4 coding classification systems
Coordinates concurrent and retrospective quality audits to ensure compliance with regulatory agencies and reports findings to corporate compliance and other departments as appropriate
Provides and coordinates education sessions for coders and other Medical Center personnel who perform coding tasks
Monitors compliance with policies and procedures relevant to clinical data management
Assists in preparation of medical studies by identifying data elements
Oversees the analysis of physician documentation in the medical record for coding compliance
Assists physicians and physicians' office mangers with coding inquiries
Maintains and updates procedural workflows and departmental policies and procedures related to medical coding
Ensures departmental compliance with the Medical Center's patient privacy and medical information confidentiality policies
Minimum of 5 years experience and thorough knowledge of Case Mix Index, ICD-9-CM, CPT-4 and DRG and APC methodologies
Experience interpreting billing forms and knowledge of CDM requirements
Knowledge of clinical databases and data reporting requirements
Experience with auditing for quality improvement
Proficient in computer skills
Associate's or higher
RHIA or RHIT with CCS or candidate must attain said certification(s) within 6 months of hire

131

Manager Clinical Quality Resume Examples & Samples

Team Management: Manage staff within the quality management department, including employees who conduct provider- and member-focused interventions to meet Medicaid and Medicare quality performance goals
Annual Regulatory Reporting: Responsible for design, implementation and approval of quality improvement programs and work plans, as well as development and approval of annual quality program evaluations
Quarterly Regulator Reporting: Responsible for analysis, creation and delivery of quarterly regulatory reports and for ensuring compliance with all quality management requirements specified by regulator in policy or contract
Quality Improvement Design: Responsible for selection and design of new improvement projects based upon analyses, literature review and other quality reviews to improve member care
Quality Improvement Interventions: Responsible for maintaining or improving performance upon contractual and nationally required quality performance metrics, including HEDIS and customized state measures
Audits: Oversee quality audits to ensure appropriate collection, tracking and reporting upon medical records required for focused quality improvement studies or regulatory audits
Management of external contractors: Oversight of external contractors such as HEDIS contractor if needed
Quality Liaison: Serve as a leader in cross-functional meetings to accomplish quality improvement and quality compliance goals, and serve as a liaison for regulators or other community-based organizations as needed
Committees and Presentations: Facilitates health plan quality committees by either participating as appropriate or making formal presentations
Located in / near Phoenix Arizona
Able to obtain minimum qualification as a CPHQ or CHCQM or already possess comparable education and experience in health plan data and outcomes measurement suitable to meet regulatory requirements
4+ years working in managed care quality department in Medicaid/Medicare or equivalent experience in non-managed care setting
2+ years demonstrated leadership and team development skills
Proficiency in software applications that include, but are not limited to, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3+ years in Manager / supervisory position
Proven success managing and implementing quality improvement programs
Demonstrated ability to assist with focusing activities toward a strategic direction as well as develop tactical plans and drive performance
Demonstrated problem solving skills with the ability to systematically analyze problems, draw relevant conclusions and devise appropriate courses of action
Experience analyzing and presenting complex information to key stakeholders verbally and in written form

132

Manager, Clinical Outsourcing Resume Examples & Samples

Perform and manage all activities associated with the development and execution of contracts for all pre-clinical and clinical (CDRA) services to include Regulatory and Medical Affairs. Support of Commercial and Marketing activities may also fall in scope of this position
Prepare study specific request for proposals (RFPs); manage and influence RFP process (vendor selection), competitive bidding negotiations, benchmarking and sourcing strategy. Prepare RFI's
Track, manage and monitor all changes to study scope ensuring timely change order finalization and implementation
Develop, track and report on CRO performance metrics
Utilize CTMS (ClinForce or similar) and clinical budgeting, planning and forecasting tools (Clear Trials or similar.)
Manage vendor relationships and issue resolution of moderate to high complexity, support project team in resolution of performance issues
Involved in projects or programs (complex and multiple.)
Anticipate & prevent problems & create backup plans
Identify new best practices
Contribute to continuous improvement
Member of cross-functional teams- may lead mtgs. as appropriate and influence line functions
Train & coach others in processes and industry practices
7 years Procurement experience, 5+ years in the Pharmaceutical Industry; 3+ years in outsourcing Phase I -IV clinical trial services

133

Manager Clinical Oncology Specialists Resume Examples & Samples

Coach the COS as a clinical sales person to ensure they
Bachelor of Science in Nursing or RN degree AND
8 years clinical or pharmaceutical and/or biotech industry experience
12+ years related experience, including 8+ years’ experience in pharmaceutical and/or biotech industry, and 5+ years’ experience in Oncology, and 5+ years’ experience in management
Degree in Nursing (Registered Nurse), Nurse Practitioner or Physician’s Assistant
Track record of leading others by example and through indirect authority
Possesses keen oncology market knowledge, strong business acumen, and strategic thinking, communication and presentation skills
Successful in developing relationships with key nursing and Advanced Practitioner organizations, targeted accounts, state societies, and other key customers

134

Manager Clinical Oncology Specialist Resume Examples & Samples

In collaboration with the district manager, recruit, interview, onboard, manage, coach, and develop the COS as a dotted line reporting structure to the MCOS, and according to company procedures and policies
Proven ability to manage a large geographical territory
History of building and developing highly effective teams, and working in teams

135

Key Account Manager Clinical País Vasco Resume Examples & Samples

Build and maintain relationship in order to promote instrumentation and reagents sales, insuring customer relationships are optimized to achieve sales targets and budget, while keeping the overview about the sales territory in terms of understanding the opportunities, risks and competition’s activities
Ensure a sufficient number of visits to customers, respecting the “norm”/objective set in the territory. Respect the basics of the bioMérieux Sales Excellence principles
Execute the SBO meeting plans of actions as agreed with Sales Management
Interact cross-departmental co-operation, leading to best possible and efficient team work to promote instrumentation and reagents sales, insuring customer relationships are optimized to achieve targets and budgets ; liaise with Corporate Account Manager(s), Business Development Manager(s), Application Specialist(s) and Product Manager(s)
Prepare quotations, proposals, tenders, negotiate prices within limits of authority
Report on sales, activity and territory performance as required by organization. Refer to Sales & Marketing management customers feedback & information on market changes & competitors activity to respond to changing market conditions
Keep the Sales Force Automation (CRM) tool daily and correctly up-to-date (customer address, contacts, opportunities, activities..)
Ensure sales activities comply with legal and ethical standards as well as company policies
1 Typical Studies-Experience, Skills and Qualifications
1Studies-Experience
University degree in Bioscience ( Physician, Biologist, Pharmacist, Chemist)
Sales Experience required, minimum of 3 years selling experience, capital equipment sales preferred or experience working in laboratory environment, and/or previous life science sales experience
2 Skills and Qualifications
Strong knowledge of bioMérieux product ranges/services/solutions and Sales strategy, IVD market and competition understanding. Sales results orientation and integration of the selling process and sales tools
Intermediate computer literacy
Very good organization, interpersonal, communication and presentation skills. Team spirit
Spanish and Vaske mothertongue or bilingual required
English higher than upper intermediate required

136

Manager, Clinical Applications Southeast Resume Examples & Samples

Provide managing, coaching and, developing of the local COS team who assist customers with the proper use of Alcon products to ensure optimal patient outcomes
Supervises the local COS team who provide technical and clinical training, education and ongoing support to certify surgeons and OR staff on the use and application of Alcon’s Cataract and Refractive Laser Products, including excimer, femtosecond and diagnostic technology
Supports COSs efforts in providing on-site and/or remote clinical application support to customers by providing scientific, technical information in response to inquiries regarding use of Alcon medical devices at customer sites via clinical support and monitoring
Review surgeon outcomes where permitted given local privacy laws, and support clinical data collection as appropriate and approved in compliance with GCP
Ensures COS successful implementation of all software upgrades at clinical sites for all relevant devices. Oversees COS direct reports to identify and report all adverse events and device deficiencies to Medical Safety per company protocol
Assigns COS to follow-up on root cause analysis and requests for feedback/input from physicians as requested by Medical Safety, where appropriate
Serve as conduit of COS feedback to R&D via approved communication plan on clinical performance of products
Ensures appropriate COS responses to unsolicited HCP requests for information related to Alcon medical devices, per SOPs and Ethics and Compliance Guidelines
Assigns COS attendance to support trade shows, fellowships, conferences, exhibits, seminars, and wet-labs as appropriate
Provision of Field Shadowing of COS direct reports in support of on-the-job training as part of the COS certification process
At the request of Region COS Lead, may help support the Global COS Training Team to customize centrally developed training materials to meet regional product approvals and approved uses
May identify opportunities for enhanced training of COS to fill gaps or further enhance competence to achieve best in class capability
Maintains focus on priority clinical sites and minimize distractions through transition to future state
Optimally manage COS resources within geography to ensure coverage of key customers and initiatives
Supports the product adoption goals and medical affairs strategy to optimize surgeon and patient outcomes
Recruits, retains, trains, and grooms talent to meet COS training readiness requirements

137

Manager, Clinical Documentation Resume Examples & Samples

Active study team member for assigned studies; may act as a CDC SME contact and/or CDC lead for a particular TA or Program
Ensures real-time inspection readiness of clinical documentation by collaborating with Artifact Owners, reviewing assigned TMFs to ensure accuracy and completeness, and tracking and reporting status to study team(s)
Develops and updates study-specific TMF structure documentation
Partner with CDC Operations colleagues to drive process enhancements
Complies with GCP, AbbVie SOPs and functional area processes

138

Manager, Clinical Quality Resume Examples & Samples

Manages day-to-day quality activities ensuring program and procedures support company goals for service, quality, and cost effectiveness as well as compliance with contract, federal and state requirements. Activities and projects may include
Interfacing with customers on quality programs
Trainings on CQI processes
Coordination of quality initiatives
Satisfaction survey coordination and follow-up
Coordination of Advisory Groups
Tracking of adverse incidents and Quality of Care concerns
Monitoring of performance measures
Provider profiling support
Auditing for quality control
Quality studies and quality improvement projects
Prepares customer and site reports with assistance from Reporting and Analytics team
Participates on quality committees to ensure quality issues are taken to the committee and recommendations are made, by the committee, in a timely manner. Makes recommendations to the Committee for improving plan operations based on data from performance indicators, QI studies, and quality activities
Serves as liaison with assigned departments to ensure quality projects are integrated within operations
Conducts internal audits of charts and clinical/service procedures for quality purposes

139

Manager, Clinical Services Resume Examples & Samples

Along with physician hospitalists / PCPs / Specialists, Clinical Manager leads and coordinates activities of interdisciplinary treatment team required to make complex clinical, benefit and network decisions
Analyze data to identify under/over utilization; improve resource consumption; promote potential reduction in cost; and enhance quality of care consistent with MemorialCare Medical Foundation strategic goals and objectives. Data includes but is not limited to predictive analysis, risk stratification, cost-benefit analyses, financial analyses; clinical outcomes; utilization and practice patterns
Utilization decisions and documentation demonstrates prudent utilization of resources, identifies opportunities for potential cost reduction; promote quality care and comply with regulatory guidelines needed to maintain delegated status from contracted health plans
Oversees approval, denial and appeal processes, including implementation of appropriate denial letter language to meet regulatory standards
Manages day to day oversight of activities associated with utilization management nurses for the management of referrals, regulatory compliance, critical analysis of criteria and clinical history to make referral determinations for approvals and or denials
Interprets and applies delegation agreements, divisions of financial responsibility, contracted provider lists, evidence of coverage, health plan operations manuals, and MemorialCare Medical Foundation policy
Assures review turnaround times adhere to timeliness standards set by contracting and regulatory requirements and established productivity and quality guidelines
Independently analyzes and assigns coverage by allocating resources and directing the day to day activities to departmental advantage
Identify, prepare and maintain utilization management reports as needed for both staff and executive leadership
Assign, manage, and/or handle special projects delegated by Director and executive leadership
Develop and implement quality and productivity standards then establish the expectations with the staff in the performance of their jobs
Develop and maintain templates, forms, reports, and other tools that will assist the staff in meeting the needs of the department, patients and providers of the organization as it relates to utilization management
Ensure referrals are reviewed and completed in EMR in a timely manner
Interface with other departments to resolve issues associated with cases managed by the staff
Identify, develop and conduct training for staff and/or coordinate with trainer for new hires or when additional training is needed
Identify and resolve the root cause of problems associated with the utilization management area of responsibilities. Develop and implement a plan to address the issue
Participates in Contracting and Provider Relations activities as necessary to develop and maintain provider networks. Consult on Network steering and leveling as per UM experience and referral data
Review, revise, and develop policies and procedures for the department as needed
Evaluate personnel to coach, counsel and/or discipline employees as necessary to improve performance
Monitor time and attendance of assigned staff
Provide support to Director and Medical Director
Participate in other duties as assigned to meet organization strategic goals
Licensed Registered Nurse preferred or have a college degree as an LVN
Minimum of 5 years’ experience in utilization management and Managed Care
Minimum 2 years supervisory experience preferred
Excellent communication skills, including written and verbal
Knowledge of regulatory requirements, Health plan contracts, delegation requirements, Medicare, Managed Care, utilization management
3 years’ work experience working with evidence based guideline, criteria (i.e.: MCG, Interqual, Hayes); Health plan medical policy / clinical coverage guidelines
Working knowledge of Microsoft applications – Word, Excel
Ability to perform complex problem solving and project management

140

Associate Manager, Clinical Services Resume Examples & Samples

Develop focused process improvement initiatives to ensure positive system hospital adoption of process and products to demonstrate improved patient outcomes that drive sales performance (e.g., overall sales revenue
Partner with leadership to develop design strategies and drive utilization of multiple program initiations and development in large hospital systems
Create and successfully lead the implementation of customized clinical processes and systems with assigned hospitals and hospital systems (e.g., IDN) in partnership with multiple and matrixed staff members
Serve as an expert resource to internal and external stakeholders (e.g., Clinical Field Specialists, physicians) while leveraging knowledge gained through direct clinician interactions and relationships, in order to provide relevant input to critical conversations
Research data, partner with data experts, set strategy for key metrics, and present base line and outcome findings to key stakeholders
Bachelor's degree in Healthcare administration, Nursing, or related field with 8 years OR Master's degree with 6 years of previous related experience with direct healthcare management of large clinical organizations required
Experience with quality performance, clinical process design, and/or sophisticated clinical pathways
Excellent facilitation and presentation skills
Experience managing a large clinical staff preferred
Proven expertise in MS Office Suite and related systems
Excellent written and verbal communication skills and interpersonal relationship skills including consultative, influencing, and relationship management skills
Ability to work well in a multi-cultural environment and matrix organization
Ability to relate to physicians, nurses, and senior-level healthcare managers
Demonstrated problem-solving and critical thinking skills
Extensive knowledge and understanding of Edwards policies, procedures, and guidelines relevant to hospital based systems and lean based processes (e.g., Toyota Production System (TPS))
Extensive understanding and experience in creating, implementing and managing hospital protocols and quality systems
Extensive understanding of current clinical research while applying it to clinical practice
Extensive understanding and knowledge of governmental policies and regulations on impact of care
Ability to work in a team environment, including serving as consultant to management
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

141

Manager, Clinical Improvement Resume Examples & Samples

Serves as a key resource within the organization regarding accreditation approaches and best practices. Oversees the implementation of robust process improvement following Root Cause Analysis, FMEA, and development and implementation of corrective action plans
Works with the Leadership Team to implement programs designed to uphold patient safety and quality as part of accreditation standards established by the The Joint Commission (TJC), TJC National Patient Safety goals (NPSG) and Sentinel Event Alerts, Centers for Medicare and Medicaid Services (CMS), and Texas Department of State Health Services (TDSHS)
Coordinates accreditation and clinical improvement activities with other internal programs to promote organizational effectiveness and prevent duplication of activities within the organization
In support of the quality assessment performance improvement program, utilize relevant strategies to facilitate robust process improvement from aggregate data i.e., real-time adverse event triggers (software) and voluntarily reported data
Anticipates customer needs and manages the provision of services to all customers, including patients, physicians, hospital departments, and staff
Performs other related job duties as needed
Bachelor's degree in a healthcare related field from an accredited University. Master's degree preferred
6 plus months recent work experience in accreditation and/or performance improvement
5 plus years of experience working in an acute care hospital setting or enterprise-wide healthcare system
Basic experience using Microsoft Professional Office Suite to include Word, Excel, PowerPoint and Outlook
Lean Six Sigma Green Belt (to be obtained within one year of hire date)

142

Manager, Clinical Improvement Resume Examples & Samples

Ensures clinical documentation, including modifications, accurately reflect the level of service rendered (in compliance with government and other regulations) for all patients
Performs Educational programs to the clinical staff and physicians on documentation requirements to support medical necessity
Current, unrestricted RN License
Regulatory background knowledge or HCPSC coding experience
Bachelor's Degree in Nursing or related field
Minimum of two (2) years in a leadership role preferred
Bilingual Preferred (Spanish and English)

143

Manager, Clinical Quality Resume Examples & Samples

Implement and manage programs and processes that assure the highest level of quality to support accreditation on all product lines (NCQA, HEDIS, CMS) in all markets
Assess compliance with NCQA, CMS, state (NH, ME, MA, RI and CT) and federal regulations. Communicate new regulations as appropriately to impacted areas within Harvard Pilgrim, such as Clinical Policy, Utilization Management, Product, IT, etc
Ensure that regulatory-related project documentation is developed and organized according to standards (i.e. NCQA, CMS). Upon project completion, ensure that all documentation and products are archived and maintained according to standards
Responsible and accountable for the ongoing management and maintenance of HPHC’s Quality Management Programs; includes development and execution of Annual Quality Improvement Work plan, and maintenance of HPHC’S Quality Program Description in accordance with NCQA, state and federal requirements
Identify process improvements to maximize quality, efficiency and cost effectiveness
In collaboration with clinical leadership, provide management, structure, and facilitation for the ongoing timely review of clinical practice guidelines per organizational policy, NCQA standards and state and federal regulations and identifies appropriate clinical practice guidelines for diseases and conditions pertinent to HPHC membership
Serves as subject matter expert on internal and external collaboratives related to guideline development: these include MHQP, HPHC/UBH QI Workgroup, Cost Savings Initiatives Committee, Technology Assessment Committee, Fraud Waste and Abuse Oversight Committee, Clinician Appeals Committee, New Hampshire Foundation for Healthy Communities MDPH, MCAAP, etc
Coordination, preparation and review of regulatory submissions. Development and preparation of successful regulatory strategies; defend such strategies if applicable
Collaborate with Legal to respond to Market Conduct Exams and other requests for information; Support state licensure applications and annual ad hoc reports. Responsible for RFP responses as they relate to quality and accreditation questions
Lead, manage, coach, and develop staff to effectively meet departmental goals
Other duties and projects as assigned

144

Manager, Clinical Laboratory Operations Resume Examples & Samples

Manager, Clinical Laboratory Operations - 33105 - rev. 8.22.13 Proficiency Level Collects and prepares data for the laboratory Performance Measurement Report, an ongoing quality assessment tool of the Laboratory's overall Quality Management System
Directs, advocates for and drives quality processes within all sections of the laboratory (pre-analytical, analytical and post-analytical); responsible for overall laboratory safety including hazardous chemicals, bio-safety practices, flammable storage, eyewash, air quality, etc.; actively participates on assigned AHS committees. Attends interdepartmental meetings to represent laboratory & pathology services as needed
Investigates client complaints, revised reports and reportable quality issues, ensuring accurate and complete responses. Implements immediate, short-term, and long-term corrective actions
Maintains quality staff by interviewing, hiring, training and providing guidance for staff development through regular performance evaluation and corrective counseling; schedules and manages vacation schedules for all laboratory staff (65-70 individuals); timekeeping system (Kronos) direct entry and reconciliation for all laboratory staff (65- 70 individuals)
Oversees and administers all aspects of the Clinical Laboratory Scientist Trainee program (1 trainee annually, 9 month practical experience through all specialty areas of the Clinical Laboratory)
Oversees moderate complexity point of care testing (POCT) performed by respiratory care practitioners, anesthesiologists, clinical pharmacists and ED nursing (approximately 200 individuals). Assures current competency and successful proficiency testing performance of test personnel and testing environment compliant with regulatory requirements
Reviews all laboratory test performance (clinical laboratory & POCT), drives process and project management, and prepares and submits required reports to meet established deadlines' evaluates and recommends modifications of test methods to or introduces new techniques, equipment or supplies for testing under the guidance of the Administrative Director of Laboratory & Pathology services
Supervises the Point of Care Testing Coordinator for waived testing (POCC; 1). Indirectly assures all POCT requirements for waived testing (staff training, competency, proficiency testing, equipment, and supplies) meet regulatory requirements (CAP, Joint Commission) for 1200 individuals at HGH, JGPP and FH

145

Account Manager, Clinical Engineering Resume Examples & Samples

Oversees operations of Clinical Engineering Department by: conducting quarterly department head visits and meetings; ensuring that client reports are delivered in a timely manner; providing a working environment that meets all OSHA, Joint Commission and other guidelines. Completing and maintaining all performance indicators for the various facilities at or above program targets
Ensures financial performance of department by: conducting regular department head visits and meetings to review performance of Clinical Engineering program; maintaining PM/CM completion at or above program targets; being actively involved in capital asset planning, purchasing, etc., and other committees as assigned; completion of customer satisfaction surveys with appropriate results
Ensures smooth communications and reporting to and from all appropriate administrators at each site. This includes conducting all necessary meetings with facility administrators, and forwarding all positive and negative customer/vendor communications to Area Manager for review. Provides weekly reports to Area Manager
Provides professional team and personal growth that meets the needs of multiple location accounts with a broad focus on all technologies
Grows the program by gaining the confidence of clinical department heads and maintaining positive relationships with the appropriate administrators at each location
At least five years of experience in a Supervisory role required

146

Account Manager, Clinical Engineering Resume Examples & Samples

Ensures smooth Market Leadership communications & collaboration within CE regionally. This includes conducting any necessary meetings with Market Leadership, and forwarding all positive and negative customer/vendor communications to the CE Division Director for review
Oversees operations of assigned PAS-CE Departments in their market based area by conducting monthly/quarterly department head visits and meetings; ensuring that requested customer reports are delivered in a timely manner; providing a working environment that meets all regulatory guidelines; and completing and maintaining all performance indicators at or above program targets for assigned CE departments as well as meeting Market level communications requirements
Maintains a routine working relationships with Divisional & Hospital Leadership to ensure standardization and market level communications about CE services and compliance with regulatory guidelines
Ensures financial performance of departments by: attaining all expense budgets and cost containment targets; ensuring that expenditure authority and level are adhered to; and forwarding, in a timely manner, all appropriate PO’s, invoices and financial details to the appropriate sources
Provides oversight of PAS-CE account managers in the region with regards to CE staff training; customer interactions; Project Management; and standardization of market level communication as well as regional service strategies. This oversight also includes region wide vendor management & contracted services, regional staff meetings; providing measurable regional objectives; ensures the completion of regional policy & procedures for CE and performing hospital specific PQE’s
Provides professional team growth that meets the needs of the customer and employees
At least ten years of experience in a senior/lead technician, with a minimum of five years of experience as an Account Manager
Must have working knowledge of all elements of CHI PAS-CE Program and/or industry standard clinical engineering management

147

Manager Clinical Appeals Resume Examples & Samples

Tactical execution - oversees the development, deployment and direction of complex programs and
Minimum 3 years management experience in hospital revenue cycle operations
Minimum 2 years appeals or denials experience for hospital revenue cycle operations

148

Manager Clinical Management Resume Examples & Samples

Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
Strong organizational and negotiation skills
Good knowledge of English language and grammar
Competent use of computer to include data entry, archival and retrieval
Solid knowledge of medical/therapeutic areas and medical terminology

149

Account Manager Clinical Diagnostics Germany Resume Examples & Samples

Area: Germany North: Hamburg, Lübeck, Kiel, Schwerin
Achieves monthly, quarterly, and annual sales quotas
Identifies and develops new client opportunities
Creates and utilizes a territory sales plan
Prioritizes project planning, meeting competing customer requests/deadlines and organized territory management
Manages contacts, activities, calendar, and sales pipeline through daily use of SalesForce.com
Works in conjunction with marketing and other sales teams to develop and implement sales and marketing plans
Develops and demonstrates a thorough understanding of selling skills and sales forecasting
Strong technical skills to demonstrate instruments and/or consumables for research
Intermediate computer skills including Microsoft Office
May involve basic laboratory skills, including sample preparation
Master degree in biology or equivalent
5+ years of sales experience selling products in the medical instruments marketplace or equivalent combination of education and experience

150

Manager, Clinical Quality Data Resume Examples & Samples

A Master’s degree in a clinical health-related field
5+ years experience evaluating, refining, and improving clinical data collection, analysis, and reporting, with 2+ years of experience in a managerial or supervisory role
Demonstrated knowledge of hospital and health system operations
Education and training in information systems, related to clinical data collection and analysis
Knowledge of statistics, and computer applications to include graphic presentation, statistical analysis, and spreadsheet software packages
Excellent analytical, organizational, and written/verbal communication skills
Ability to work independently, coordinate multiple projects simultaneously, and meet required deadlines
Preferred qualifications include: Doctorate Degree in Health Services (Public Health), Epidemiology, Biostatistics, Information/Computer Systems or related field; previous experience in a consulting capacity, and in writing programs to support clinical data collection
hotjobs**

151

Manager, Clinical Ops / Data Analytics Resume Examples & Samples

Oversee and contribute to the collection, analysis, and summarization of information and medical trends in order to prepare standard and ad hoc reports as required by the Clinical Operations leadership
Proficient in both data aggregation and managed care specific acumen to interpret data. Hands on expertise in SQL programming and experience with enterprise wide data warehouses
Create models that will provide the information necessary to track and evaluate the success of clinical interventions and case management, on both a macro and micro level
Evaluate data trends and make recommendations based on findings for interventions aimed at reducing costs, decreasing inappropriate utilization, and impacting quality and clinical outcomes
Communicate actionable findings, provides recommendations to departmental leadership as well as other senior/executive management as appropriate
Act as a liaison to IT and other departments as needed on behalf of the Clinical Operations department, as subject matter expert on care management, utilization management, and related clinical data
Hire, orient, and train employees in order to maintain staff to meet objectives. Provide day to day guidance and tactical direction. Provide information, educational opportunities, and experiential growth opportunities in order to develop staff. Plan performance expectations, monitor, and appraise the associate's job results and performance
Job performance requires fulfilling other incidental or related duties as assigned, assisting and training others, and performing duties of higher rated positions from time to time for developmental purposes

152

Product Manager Clinical Solutions Individual Products Dach Resume Examples & Samples

Data-driven product management implementation
Driving market research (customer needs and readiness, competitors, macro drivers) for reference products
Defining, maintaining and executing product development roadmap for e-products as well as supporting segment marketing to sharpen value proposition, drive awareness, acquire leads and drive direct sales
Supporting sales team in driving the sales and working with them to identify, prepare, lead and close sales opportunities in domain of e-products
Making sure we optimize our commissioning, reduce costs as well as time-to-market, prevent slippage and provide sales and marketing excellence for books
Further extend/ sharpen Elsevier's thought leadership in the field of Clinical Decision Support in DACH and Eastern European region
Organizing Elsevier events and presenting at other industry events (write and submit papers etc.) to drive awareness of reference products
Building up/ deepen relationship with medical societies and associations as well as to the respective opinion leaders
Building up and deepen relationships and cooperation with Physician Information System vendors
Delivering revenues
EProduct Management Experience
Experience in developing and selling (medical) apps
Strong direct sales/ app store sales background
University Degree or equivalent experience
Business fluency in Germany and English

153

Program Manager, Clinical Transformation Resume Examples & Samples

Develops Plan of Concept (POC), Project Charters, Project and Business Plans
Performs investigations, analyses, and evaluations to determine project feasibility
Prepares project status reports
Ensures facility resources meet site management and data monitoring objectives
Provides project status information to team members including attending meetings and following-up on action items
Ensures adherence to protocols, procedures, and project plans
Participates in identification, evaluation, and selection of pilot sites
Maintains relevant documentation and communications as part of program library
Establishes and maintains working relationships to obtain information and content from providers for health system selections
Develops or assists in development of work plans, task sequencing, and runs test cases to evaluate the extent of how tasks may be performed concurrently
Supports Senior Management to achieve project goals for submission and approvals, facility initiation, source document verification, data monitoring, ownership and accountability, and facility/site closure
Supports short and long term operational/strategic business activities - by developing, enhancing and maintaining project information and models. Develops and implements effective/strategic business solutions through research and analysis of data and business processes
Develops and manages best-practices and tools for performance improvement plan execution and management. Identifies and manages performance improvement dependencies and critical path issues
Serves as an operational resource for internal team members for expedited problem identification and resolution, provision of project-specific updates, and team interactions and deadlines
Coordinates project site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required
Adheres and assists with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides)
Bachelors Degree in Systems Engineering, Business Administration or related field, required. MBA/MPH Degree, preferred
Minimum of five to five (5) years experience in project management within a healthcare environment, required. Administrative and project management knowledge, preferred
Excellent planning and problem solving skills
Excellent communication skills and ability to communicate effectively with all levels of the organization
Ability to travel up to 30%, based on project needs
Proficiency with Microsoft Visio, Project, Excel, Word and standard computer programs required
A highly-motivated and meticulous individual with excellent problem-solving and communication skills to join a fast-paced, growth-oriented work environment in a cutting-edge field of clinical transformation

154

Senior Manager Clinical & Outcomes Sciences Resume Examples & Samples

Provide project management for Investigator Sponsored Research program
Work closely with Medical Directors (MD) and Project Management team to ensure areas of non interest are contained within the Core Medical Plan
Monitor ISR portal for new submissions. Review and route to appropriate Medical Director for evaluation by the appropriate ISR Committee
Coordinate and facilitate ISR Committee meetings, pre committee meetings and ad hoc ISR related meetings at the discretion of the Medical Director or the Associate Director, Clinical and Outcomes Sciences
Primarily responsible for overall study file and documents per ISR process and GCP guidelines
Manage, monitor and report on study timelines, budget, regulatory and publication status of assigned studies
Facilitate working meetings for budget monitoring, process improvements and database updates for MAA
Exercise clinical trial management skills to include development of a budget, reconciliation of budget items and study contract negotiations
Provide study oversight/management support for MAA data generation activities including vendor management
Assist in the creation and implementation of process improvements and help lead organizational change; share and adopt best practices to improve cross-functional competencies as related to the objectives of Medical Affairs, Americas
Minimum of a Bachelor's Degree in Science
Minimum of 7 years of experience with a BA or BS OR minimum of 5 years of experience with a MS
Proven Project Management skills
Demonstrated ability to manage multiple projects and competing priorities
Demonstrated high level of competence with MS Office applications, SharePoint, Documentum and Microsoft Office applications. Ability to gain a good working knowledge of the ISR database
Excellent collaboration and communication skills to facilitate team discussions and drive optimal team performance
Demonstrated knowledge and understanding of research protocols and study design
Proficient in developing reports for leadership oversight
Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organization and planning skills, accounting and computer skills particularly with Microsoft Word and Excel
Ability to monitor expenditures, maintain data and confidentiality

155

Senior Manager, Clinical Outsourcing Resume Examples & Samples

Prepares contracts and leads vendor negotiations of moderate to high complexity
Responsible for identification of new service providers via regular market surveillance and awareness of industry trends
Excellent negotiation shills

156

Senior Manager Clinical Engineering Resume Examples & Samples

Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in leadership behaviors, practices, supports and endorses senior leadership decisions, goals, objectives, and strategies
Provides management oversight of the region’s clinical engineering program and ensures program service support objectives are met. Provides a work environment that fosters positive energy, creativity, and teamwork among associates across all functional areas. Provides consultative, operational, and technical support to RHM’s, managers, and system office in support of medical equipment; capital planning, safety, hazard alerts/recalls, asset management, business structure and growth opportunities
Reviews and monitors short and long-term regional financial plans and objectives to ensure regional financial objectives stay on course and drives initiatives with RHM teams that contribute to Trinity UEM and THCE program short and long-term operational excellence. Measures successes and deficiencies and recommends any corrective course of action and monitors implementation and compliance assessment. Approves purchases within established scope and authority
Has fiduciary responsibility for the region’s monthly outcome of program finances and works with others to prepare and submit program annual revenue and expense budgets recommendation to THCE leadership. Participates in monthly budget reviews with the Director, THCE Operations and finance representatives to identify budget variances; and prepares related reports for senior management review
Collaborates with THCE leadership, fellow RDs, CE Managers, and RHM leadership at all levels in determining potential cost reduction opportunities, evaluating best maintenance strategy options (e.g., risk pool utilization, outside service support options, training of in-house CE staff, etc.) and reviews key strategies to determine impact on the overall CE program operations and objectives
Schedules site visits to meet with CE associates, RHM senior leadership, and select clinical department leadership, to discuss and assess the clinical engineering program service delivery and to address issues/concerns; outlines and follows up on necessary corrective measures. Assists in resolution of vendor-related problems and provides updates to the Director, THCE operations
Keeps Director, THCE Operations informed of issues affecting program costs, effectiveness, and efficiencies, as well as issues noted during RHM visits. Presents findings and recommendations to the Director, THCE Operations to be used in strategic planning and other key decisions. Obtains final approval from Director, THCE Operations prior to implementing program changes to the field
Identifies, recommends, and implements best practices and operational solutions to improve THCE service delivery in the region. Works with Direct Reports and Contract Manager to ensure vendor service agreements provide expected service value, are necessary, accurately reflect accepted terms and conditions and align with future service strategy. Works with direct reports and Contract Manager to minimize reliance on outside vendor service support
Develop, implement and monitor short and long term goals and objectives that align with and support systems goals and objectives. Provides input to SLT in the development of system goals and objectives
Meets with direct reports and support staff, as required, to review preceding year’s overall operations goals/objectives, to address shortfalls and open issues, and to encourage open dialogue for suggested process improvements. Reviews subsequent FY goals/objectives and related strategic plans as defined by the senior leadership team (SLT); outlines expectations, accountabilities, and measurables used in determining success
Performs Program Quality Evaluations (PQE) and reviews Customer Satisfaction Survey scores for discrepancies and overall customer satisfaction. Prepares Performance Improvement Plans (PIP) where necessary to resolve customer satisfaction issues and address program quality deficiencies
Interviews, hires, trains, appraises, counsels, and supervises managerial level staff; handles disciplinary actions. Reviews and approves expense reports and holds direct reports accountable to Trinity Health and THCE policies and procedures. Reviews hiring justifications to ensure financial cost saving merit. Prepares Return-On-Investment (ROI) analysis, ensures projected targets are achieved and reviews results with the Director, THCE Operations
Ensures timely completion of annual performance appraisals; addresses associate problems and issues related to their work or environment. Fosters the development of diverse teams at all levels and outlines annual skills development, career growth opportunities, and improvement objectives with direct reports. Establishes and monitors progress on objectives and takes the necessary actions to resolve and prevent recurring issues. Provides the necessary leadership and oversight in cases where disciplinary action or termination is warranted
May handle additional duties and responsibilities as needed or assigned
A comprehensive knowledge of capital asset and clinical engineering management principles and practices, as normally obtained through a Bachelor's degree in Business Administration or other related field plus ten (10) to twelve (12) years of experience in a corporate or large multi-hospital level service support leadership position or an equivalent combination of education and experience
Experience in medical equipment service contract management, field operations management, project management, change management and implementing best practices in a large national service support group, leading cross-functional work teams, with demonstrated results in reducing medical equipment repair and service costs
Ability to work effectively in a diverse, collaborative, and team oriented culture
Ability to develop methodologies for collecting and analyzing relevant data; to audit CE program processes; monitor quality; identify, problems and their root causes, and make recommendations for improvement
Excellent leadership, analytical, organizational, planning, delegation, coaching, communication (verbal, written and interpersonal), and computer (MS Word, Excel, Outlook, PowerPoint) skills; with a continuous improvement mindset and ability to challenge conventional thinking at all levels of the organization
A personal presence characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health
Ability to be a self-starter and independent worker able to manage multiple conflicting priorities and demands
Ability to delegate responsibilities effectively and provide regular follow up to ensure objectives is met
Must be able to travel with overnight stays 50% of the time

157

Global Category Manager, Clinical Services Resume Examples & Samples

To develop and refine category strategy including determination, implementation and management of the applicable governance structure
To liaison with Roche stakeholders (PD, pRED, gRED, GPS and GMA/gMED) to ensure that the category strategy is aligned
Drives and is accountable for the global contracting process with suppliers safeguarding Roche’s best interests at all times. Sets strategies to manage pricing negotiations ensuring competitive market prices are applied. Will drive and contributes to the over departmental savings objectives
Benchmark and evaluate the market to identify potential suppliers. Strategically sources, allocates and manages preferred suppliers aligned with Roche’s guidelines and regulations. Fully drives/coordinates the Request for X (RFI, RFP) process
To maintain an oversight of the category including ongoing management of spend and demand (including identification of efficiency and value adding opportunities)
Analyze Market, Category and Supplier, including financial risks, Spend history, trends, demands and forecasts
Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology
Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations
Facilitates and coordinates the implementation of the category strategy ensuring Roche’s Global Procurement Directives are met. Provides tools, support and guidance for effective spend and budget management practices
Manages supplier’s performance and performs risk management. Develops and maintains metrics of procurement i.e. key performance indicators and continuously improves the outcomes measured
Decision-Making Authority:Commercial recommendations to business for supplier selection. Grants exceptions to bypass the procurement process. Reports non-compliant behaviour. Maintains accountability for commercial contract terms

158

Associate Manager, Clinical Device Management Resume Examples & Samples

Manage detailed metrics reporting including study compliance and employee training dashboards
Evaluate audit findings to determine severity and propose corrective and preventative course of action to resolve device-related audit findings. Ensure study compliance via internal and external monitoring, in accordance with regulatory and corporate/divisional requirements
Provide guidance on timely and accurate investigational device inventory to include recommendation of par levels and management of expiration dates, shipment initiation and returns according to regulatory and company guidelines
Develop and revise device accountability processes and workflows to ensure investigational device accountability are in accordance with regulatory and company requirements. Provide Subject Matter Expertise into the design of new systems/processes
Collaborate with cross functional global partners to forecast investigational device inventory plans. Maintain regular contact and collaborate with partner TMTT clinical teams, consultants, customers and network appropriately with relevant stakeholders
Maintain appropriate regulatory documentation both internally and externally
Ensure on time execution of all deliverables in accordance with global clinical processes, regulations and good clinical practices
Bachelor’s degree in related field required
8 years of previous clinical trial management or related experience required, preferably in the medical device industry
Proven successful project management skills
Proven expertise in Microsoft Office Suite with working knowledge of Enterprise Resource Planning (ERP) system, preferably JDE
Experience working in a medical device industry, preferred
Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
Extensive understanding of procedures as it relates to assigned area of clinical studies
Extensive understanding of related aspects of processes and/or systems
Ability to analyze and identify potential adjustments to improve efficiency
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

159

Senior Manager, Clinical Affairs Resume Examples & Samples

Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries from initiation through completion
Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications. Manage initiation of clinical sites and study protocol training, and oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Edwards Global Policies and Standard Operating Procedures. Prepare required documentation for FDA, Canada, Japan, Europe, and other regulatory submissions, including PMA's, IDE's, 510(k) CE marked and Canadian regulatory submissions
Developing and conducting clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness
Maintaining appropriate regulatory documents both internally and externally
Supporting sponsor site interaction for IRBs, contract, and training
Managing CRAs/Safety Monitors/Consultants/CROs/administrative personnel
Managing study documentation within the CTMS and eTMF frameworks
Developing and managing budgets
Managing and developing direct reports
Managing projects, processes, preparation and dissemination of study data and study reports, internal and external relationships, and Consultants
Represent the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators
Ensure all safety reporting of procedural and post-procedural adverse events and device-related complications are completed in accordance with regulatory and corporate/divisional requirements. Follow up with European/US Regulatory Affairs as necessary
Ensure device accountability by tracking the location of all clinical trial devices
Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines
A bachelor's or advanced degree in a scientific or related discipline strongly preferred (exceptions only for exceptional candidates or those with professional health certification or designation and commensurate experience)
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas strongly preferred. Must have previous managerial experience of clinical projects and people. Minimum of 6 years prior professional experience required
Requires a broad cross-disciplinary and in-depth knowledge of the clinical research profession
A qualified record of implementing new clinical projects
Experience in creating and managing budgets
Ability to meet deadlines on multiple projects required
Must be able to perform in a diverse cross-functional team environment and have ability to converse effectively with all levels of employees, management, and customers
A comprehensive record of delivering research information which adds value to management decision making process
A demonstrated ability to understand and comply with all current applicable regulations including CFR 820, Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485, Good Clinical Practice(GCP) and Company operating procedures, processes, policies, and tasks
Advanced personal computer skills including spreadsheet, word processing, database management, power point and other necessary applications preferred. Experience with CTMS systems a definite plus
Good presentation skills; ability to present material comfortably
Strong time and project management skills
Ability to exercise independent judgment and problem-solving

160

Manager, Clinical Affairs Resume Examples & Samples

Provides direction and leadership to a clinical operations project and or team
Under the direction of clinical leadership, develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
Ensures clinical trial team members are aware of their accountabilities, responsibilities and deliverables
Develops and maintains effective working relationships with affiliate teams, external CRO (for outsourced teams) and co-development partner study teams
Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Senior Director
Develops and manages clinical study budgets
Establishes study milestones and ensures accurate tracking and reporting of study metrics
Bachelor’s degree in a life science or related field with a minimum of 10 years of medical device/pharmaceutical/biotech/CRO industry experience with a minimum of 5 years of study management experience managing complex clinical studies
Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
Minimum of 5 years of independent monitoring experience as a CRA managing investigator sites
Must have previous managerial experience of clinical projects and people
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments
Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization

161

Manager, Clinical Programs Resume Examples & Samples

Regularly meet with health providers in New York City and Long Island
Provide effective management of daily operations of Clinical Partnerships programs and initiatives
Prioritize dynamic and competing projects and initiatives in order to meet departmental and organizational goals and deadlines
Create and implement protocols
Analyze project and initiative requirements to set milestones and targets that ensure timely and compliant completion of deliverables
Work collaboratively and communicate project and initiative goals, objectives and responsibilities to internal and external stakeholders
Keep all projects and initiatives focused in terms of scope and deliverable management and project time lines
Deploy, manage, monitor and mentor the clinical partnerships staff in the implementation of field and office program requirements
Create plan to monitor for compliance with all Partnership requirements for work plans, departmental documentation and protocols
Publish departmental reports and dashboards for assigned programs, and as required. This includes monitoring and reviewing Clinical Partnership dashboards and related reports against targets and objectives to ensure consistent implementation of requirements and to identify opportunities and issues that should be addressed
Facilitate meetings, conferences, advisories and workgroups with Partnership collaborators, including Healthfirst departments and external stakeholders, acting in a collaborative and consultative capacity in order to ensure completion of required tasks and reports
Communicate clearly, both orally and in writing, to internal and external stakeholders on routine basis to ensure smooth implementation of projects and initiatives
Maintain knowledge of Healthfirst benefits as well as Medical Management, Quality Improvement, Pharmacy department and Network Management policies and protocols in order to work effectively and efficiently to implement job requirements
Experience managing health-related projects or programs
Proficiency with MS Outlook, Word, Excel and PowerPoint
Ability to travel in NYC and Long Island, as needed
Master’s degree or Master’s level completed coursework
Social work or other direct patient experience
Advanced computer skills: MS Project, Intermediate Excel, PowerPoint, Access, SharePoint and/or Visio
Excellent communication, organizational and follow up skills
Ability to coordinate projects or initiatives from beginning to completion, and to meet deadlines

162

Manager, Clinical Supplies Resume Examples & Samples

Bachelor’s degree in Pharmacy or related field (MS, Pharm D preferred)
Minimum 5 years direct experience in clinical supply management
Demonstrated experience with clinical supply management planning, labeling, packaging and distribution
Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products
Knowledge of GMP batch record development, review, and approval processes
Demonstrated knowledge and application of FDA, DEA, Customs/Import, and DOT standards and regulations
Knowledge of GCP and global cGMP regulations, (Knowledge of EU GMP QP regulations is preferred)
Demonstrated knowledge of warehousing, distribution (including cold chain distribution), and logistics
Excellent project management and communication skills

163

Manager, Clinical Engineering Resume Examples & Samples

Inform hospital (and other entity) management staff of operational and financial aspects of the clinical engineering services performed at their sites
Determine proper staffing levels to provide equipment support services at assigned accounts; distribute personnel based on preventive and corrective maintenance workloads
Review productivity and efficiency work data for all staff and identify areas where improvements can be made to maximize staffing resources
Make hiring and termination decisions
Meet regularly with department site supervisors/team leaders to review previous work completion data, future scheduled work assignments, quality assurance issues, new equipment inspections and any other projects or equipment support needs
Work with department site supervisors/team leaders and clinical engineers on projects related to new equipment acquisition, installation, renovation, modification or removal. May directly over see the progress and status of such projects
Determine training needs for staff technicians and engineers and recommend/implement arrangements as needed to obtain necessary training, test equipment and tools needed to expand the areas of technical services provided by the departments
Ensure that work requests from equipment users are responded to within established timeframes
Participate in development of departmental and hospital-based continuous quality improvement initiatives
Understand and comply with Joint Commission and other applicable standards and regulations
Special projects as assigned by Manager
Bachelor’s degree or 5 years of experience in the biomedical/imaging service industry
At least 3 years management or supervisory experience
Knowledge of many different types of patient care equipment
Knowledge of electronic theory and technology
Ability to use basic computer software packages
Ability to evaluate maintenance and cost data related to medical equipment
Ability to evaluate equipment service needs and communicate with clinical equipment users on proper device use and safety
Ability to evaluate staff and outside vendor staff productivity and to ascertain quality of equipment support services provided by both hospital and outside vendor staff
Ability to write reports and make presentations on operational and technical issues
Experience recruiting, building and managing high performing teams

164

Manager, Clinical Management Resume Examples & Samples

Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff
Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
May provide input into bids and contribute to the procurement of new business where required
Excellent mentoring/leadership/supervisory skills
Advanced knowledge of clinical trials monitoring; Remote and on-site
Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g
ICH/GCP, FDA guidelines)

165

Manager, Clinical Quality Resume Examples & Samples

Develops Quality Plans for studies and CRO’s. Ensures execution of the Quality Plans. Manages contract resources in the execution of the Quality Plans
Partners with Clinical Operations in the qualification of CRO’s
Performs audits of the internal clinic, clinical trial documents, test article reconciliation, etc
Supports the organization in preparation and management of third party inspections
Provides GCP guidance to Clinical Operations, Project Teams, and external service providers, as appropriate
A minimum of a Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline
A minimum of 7- 8 years of experience in Quality Assurance in the Medical Device Regulated industry is required. A minimum of 3 years in the R&D/Clinical Trials environment is required
Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
Strategic & tactical Clinical and Business knowledge to guide the organization in regulatory inspections is required. Strong communication, organizational and interpersonal skills
Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is an asset. Ability to effectively negotiate and influence upper management, affiliates and Regulatory Agencies to ensure that regulatory and business needs are met. Ability to manage and influence external service providers
This position has 20-30% domestic travel with possibility for international travel and will be based in Jacksonville, Florida

166

Manager Clinical Management Resume Examples & Samples

Comprehensive knowledge of clinical operations; thorough knowledge of the drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations, contract research organizations, outsourcing, and evaluation of work performed against vendor Statement of Work
Understanding of the clinical and scientific basis for assigned protocols
Demonstrated experience with working with the Microsoft suite of programs (Word, Excel, Powerpoint, Outlook). Good understanding of clinical trial related software
Understanding of technological trends and passion to develop innovative solutions that support and enhance OPDC’s competitive edge
Bachelor’s degree or registered nurse
Minimum 5 years clinical trial management or relevant experience

167

Manager, Clinical Quality Resume Examples & Samples

Clinical Quality. Develops and sustains excellence in clinical practice and promotes quality patient care by leading innovative standardized processes to support the medical practices
Leadership.Collaborates with leadership to design, implement and maintain ongoing quality and clinical risk management strategies to ensure highest level of care. Supports oversight of nursing and clinical staff performance and competencies
Project Management. Develops and maintains a strategic plan to support population health workflow design to manage low, medium, and high risk population

168

Senior Manager, Clinical Development Resume Examples & Samples

Facilitates and accelerates the designing, planning, developing and monitoring of clinical trial(s) according to FDA and ICH guidelines that meet or exceed the CDP
Forecasts and manages study-related finances within established budget parameters and communicates project status to clinical team
Manage and track study-related activities, including: set up and management of Trial Master File (TMF) and/or electronic TMF (eTMF), investigational product/laboratory kit shipments, site-monitoring visit reports review/approval, vendor agreement review/ approval and study-specific plan/guideline development
Manage Contract Research Organization (CRO)/ independent contractors and facilitate communication
Assist in the selection of trial sites and investigators and with the negotiation/execution of site budgets and clinical trial agreements (CTAs)
Track vendor contracts/payments
Identify and mitigate study-related issues in a timely and efficient manner
Tracks timely resolution of deficiencies identified in audit report
Perform periodic review of TMF/eTMF to ensure accuracy and completeness. Assist with archive TMF/eTMF following study closeout
Plan, coordinate and prepare for internal/external presentations, visual aids, slides, posters, and attend external meetings for projects
Science degree in related field, scientific background
7+ years’ experience in pharmaceutical clinical research including organizing and coordinating clinical trials
Thorough knowledge of Food and Drug Administration (FDA) ICH/GCP and European regulations
Ability to quickly adapt to new technologies
Ability to travel, including overnight travel, for business-related activities (e.g. CRO Training, Investigator meeting)
Action Oriented
Organisation
Priority Setting

169

Manager Clinical Specialist Resume Examples & Samples

As a Manager, the employee is expected to recognize the importance of and create a culture of Process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 15%) domestic and/or international
Act as Firecrest management representative with sponsors where necessary, including preparing, attending and presenting at sponsor meetings, TCs,etc
Act as a management resource to the company as a whole and particularly to the Firecrest CTSME and CFR teams, including interactions on Firecrest's behalf at a management level with ICON
Provide clinical and scientific input to global product development and business development teams and provide operational expertise in the review of product releases
Support Firecrest Executive Leadership in developing and defining strategic direction and implementing plans to deliver on this
Strengthen clinical knowledge of staff where required and serve as a resource for clinical information to Firecrest staff and initiatives
Advise product development team on features and usability and educate project teams on clinical and scientific rationale
Manage departmental performance against agreed targets and budgets, and within policies and standards ensuring that all projects are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in project implementation
Prepare performance metrics to measure product accuracy; develop and implement strategies to ensure continued success
Provide the planning and management to CTSME and CFR teams by ensuring that appropriate structures, systems, competencies and values are developed and ensures that projects are conducted in accordance with applicable regulatory requirements and guidelines
Ensure that the interfaces between CTSME and CFR teams and other departments are managed optimally
Form informal networks with company management, updating them on a regular basis on developments within CTSME and CFR teams and progress made within each department
Oversee the work of CTSME and CFR teams ensuring that it is of the highest standard; consistent with the agreed approach, in line with the style guide, instructionally effective, and engaging
Manage the recruitment of new CTSME and CFRs, the development of competency tests, choosing interviewees, conducting interviews, and selecting successful candidates
Build and motivate a high performing CTSME and CFR teams, by developing and retaining high calibre staff to the company in order to continue to meet Firecrest's quality requirements into the future
Provide leadership and direction to CTSME and CFR teams within Firecrest to ensure clinical trial projects are delivered to agreed timescales, cost and quality, and communicate progress to the Firecrest Leadership Team and/or the ICON Business
Coach and develop of direct reports to ensure high engagement and retention of teams
Manage a multi-location team. Ensure that CTSME and CFR teams work with a matrix production team in partnership to optimize project delivery in terms of revenue, quality, cost and timeliness

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