Clinical Operations Resume Samples

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C Zboncak

Callie

Zboncak

7577 Ona Crossing

New York

+1 (555) 786 0273

7577 Ona Crossing

New York

Phone

p +1 (555) 786 0273

Experience Experience

Detroit, MI

Clinical Operations Specialist

Detroit, MI

Homenick, Denesik and Murazik

Detroit, MI

Clinical Operations Specialist

Assists faculty in managing recording equipment, monitoring student safety, and manipulating simulator during scenarios
Assist with internal meetings by distributing agenda and recording and distributing minutes
Follow SOPs; assist with implementing new processes and improving existing processes as directed
May perform study monitoring, create/review study monitoring plans, and prepare monitoring visit reports, confirmation letters, and follow up letters
Assists with developing simulation scenarios, assists in creating documentation for scenarios
Assist Global Site Management group with supporting the financial/contractual planning, organization and operation of global clinical studies
Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system

Detroit, MI

Clinical Operations Lead

Detroit, MI

Welch LLC

Detroit, MI

Clinical Operations Lead

Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
Develop and implement the Clinical Operations Quality Management Plans (QMP’s) including the oversight of vendors and contractors assigned to regional or global UT studies
Ensures accurate and complete study management/data collection and transfer into the data management system
Supervises, mentors and trains Clinical Operations personnel at all levels, including: Sr. Manager, Managers, Clinical Research Monitors, CRAs, Sr. CRAs and/or Principal CRAs
Provides technical input to study designs and clinical development plans
Assist in the development and presentation of continuing education based on findings from oversight visits
Supports Clinical Science Lead by developing and managing overall study budgets along with budget and contract negotiations with study sites, central laboratories and CROs

present

Philadelphia, PA

Director of Clinical Operations

Philadelphia, PA

Wunsch-Mills

present

Philadelphia, PA

Director of Clinical Operations

present

Uses Performance Improvement process to improve patient safety and patient outcomes
Lead provider network collaboration strategies, including guiding provider implementation and partnerships to facilitate gaining support of the CareMore model
Develop and routinely update comprehensive medical management work plans/programs to ensure revenue accuracy
Works with leadership to establish, implement and evaluate performance standards/expectations for the clinical organization
Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities
Analyze financial and operational data to uncover performance issues and leading the execution of improvement opportunities
Follows established guidelines for compliance with Infection Prevention and TJC Patient Safety Goals and Practices

Education Education

Bachelor’s Degree in Life Sciences

Florida International University

Bachelor’s Degree in Life Sciences

Skills Skills

Knowledge of applicable State and Federal regulations
Strong attention to detail
Knowledge of Human Resource practices
Proficiency in QAPI systems
Strong computer skills including Microsoft Excel, Word and PowerPoint
Able to multitask efficiently and effectively
Solid analytical and critical thinking skills
Strong assessment, clinical, and documentation skills
Strong organizational skills
Knowledge of CHHA regulations

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15 Clinical Operations resume templates

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Director of Clinical Operations Resume Examples & Samples

Masters (or equivalent) prepared RN with 10 years of nursing experience and at least 5 years of progressive management experience
Proven managerial track record
Previous experience in program development
Strong computer skills including Microsoft Excel, Word and PowerPoint

Associate Director of Clinical Operations Resume Examples & Samples

MA in Nursing or related / MBA
10+ years of nursing experience with some management experience
Overall operational/budgetary knowledge
Knowledgeable in emergency room operation, budgeting, and ambulatory care

Clinical Operations Analyst Resume Examples & Samples

Proficient in Microsoft Access and Excel
SQL
Healthcare industry knowledge/experience

Clinical Operations Leader Resume Examples & Samples

Minimum of twelve years of experience in the pharmaceutical industry, oncology preferred
Minimum of six of those years must have been working in an environment of clinical study delivery/clinical project management
Extensive and proven experience in driving operational delivery to timelines, cost and quality
Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery
Proven Global Project Management experience with expertise in program level resource and budget management
Bachelors of Science or Bachelor of Arts degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavors
Certification or Degree in Project Management is a plus

Market VP of Clinical Operations Resume Examples & Samples

Board Certified MD/DO in an ABMS Medical Specialty
Active, unrestricted FL license
Experience in longitudinal care management/population health
Extensive Medicare/Medicaid knowledge
Experience in healthcare policy development and advocacy
Knowledge of South Florida Healthcare Market
Minimum 5-year experience in C-Suite position
Ability to excel within a highly matrix environment, with regular interface to centralized and field-based operational/business functions (finance, network/contracting, medical management, sales, customer service, etc.)
Demonstrated ability to partner across functions to create/deploy effective win/win strategies; thinking at an enterprise level
Ability to lead cross-disciplinary teams
References who will speak to leadership competencies, collaboration, emotional intelligence and other Humana “cultural fit” requirements for our executive leaders
Exemplary written and verbal communication skills to a wide range of both internal and external audiences
Commitment to recruiting/developing diverse talent to meet the dynamic business requirements of the market
Board Certified in either Internal Medicine, Obstetrics and Gynecology, Family Medicine or Geriatrics
Clinical experience in either Obstetrics, Pediatrics, Internal Medicine, Family Medicine or Geriatrics

Director of Clinical Operations Resume Examples & Samples

Connecticut State Registered Nurse license
2 years of Supervisory experience in home care
Knowledge of applicable State and Federal regulations
Knowledge of CHHA regulations
Knowledge of Medicare COP, DPH State Licensing regulations, utilization review, CHAP accreditation process and health care budgeting
Knowledge of Human Resource practices

Regional Director of Clinical Operations Resume Examples & Samples

8+ years of Home Care experience; 5+ years of Management experience
Bachelor’s degree in Health related field
Previous Operations experience
Master’s Degree in Business or Healthcare

Clinical Operations Analyst Resume Examples & Samples

Proficient in Microsoft Access and Excel and SQL
Claims knoweldge
MRM system

Clinical Operations Consultant Resume Examples & Samples

Extensive knowledge of multiple types of Current Procedural Terminology and Healthcare Common Procedure coding systems
Comprehensive knowledge of Microsoft Word, Excel and Access
Master’s Degree in Business, Finance or related fields

Clinical Operations Director Resume Examples & Samples

Prior work experience in the health solutions industry
Demonstrated success directing and leading large teams
Demonstrated experience with continuous performance improvement principles
Must be able to travel as needed by the business. Anticipate approximately 25% of time
Master’s Degree in Business Administration, Health Administration or a related field
Prefer residence in the Eastern and Central time zones

Clinical Operations Director Resume Examples & Samples

Has worked in a very rigorous compliance-driven environment
Experience working in a fast paced environment. Have to adapt quickly to changing compliance rules
Leading 700 or more associates – taking large teams through large change initiatives
Experience having rolled up their sleeves in creating improvements through process, technology, reporting, and training. Evolving our capabilities in all four areas
C-suite experience– with weekly updates through Humana
MUST have successful cross-functional experience in a medium to large sized company

Director of Clinical Operations Resume Examples & Samples

5+ years of Outpatient and/or Multi-specialty Medical Group / Practice experience
NYS Registered Nurse (RN) or Nurse Practitioner (NP) license
Solid understanding of Outpatient, Ambulatory Practices
Previous experience with Management and Operations
Experience with NCQA and ACOs
Experience with a Patient-Centered Medical Home

Clinical Operations Analyst Resume Examples & Samples

Proficient in using Microsoft Excel to analyze large amounts of data
SQL querying experience
Process documentation experience

VP of Clinical Operations Resume Examples & Samples

10+ years Utilization Management experience in a Managed Care / HMO organization; 5+ years of Managerial experience
Bachelor’s Degree in Business or a related discipline or the equivalent work experience
Experience with State and external accreditation managed care audits and reviews
Experience with writing and implementing program level policy and procedures
Experience applying medical management treatment guidelines, such as InterQual / McKesson, Milliman

Head of Global Clinical Operations Malaysia Resume Examples & Samples

Possess a Degree in life science-related field
At least 5 years of experience in pharmaceutical clinical development
Experience in conducting global registration clinical trials
Experience/ exposure working in multi-national pharmaceutical industries
Experience/ exposure in a broad range of therapeutic areas (preferred areas include infectious disease, virology, oncology, psychiatry, cardiology and internal medicine)
Experience in Clinical Research, have Good Clinical Practice, Global and Local Regulations relevant to Clinical Research
Strong Management and leadership skills
Experience in building and motivating a high performing team
Strong communication skills (written and spoken)Clinical Research non-MD

Senior Clinical Operations Director Resume Examples & Samples

Required: Bachelor's degree in Business Administration, Healthcare Administration or related field
Preferred: Master’s degree in Business Administration, Healthcare Administration or related field
Required: 3-5 years of appropriate experience
High degree of preference given to individuals with experience in managing physicians & their operations within an academic environment

Clinical Operations Dir Amb Services Surg Spec Clinics Resume Examples & Samples

Ability to manage multiple organization missions
Facilitation, consensus-building, and negotiation skills
Sensitivity for and understanding of clinical disciplines and issues
Understand cost containment and managed care systems
The ability to work with all types of individuals in multiple settings and locations and to promote diversity in the workplace
Knowledge of necessary regulatory bodies including North Carolina Nurse Practice Act
Expert communication skills
5 years of nursing experience. At least 2 of the years of nursing experience must be in a management role

Clinical Operations, Lead Resume Examples & Samples

Previous experience in a lead or supervisory role
3+ years experience in a clinic office setting and good people management skills
Some post High School education or training in office management or healthcare
Experience with multi-line telephone system and computerized scheduling system
Good medical terminology
Excellent Excel or spreadsheet knowledge
Excellent telephone management skills
Excellent interpersonal communication skills. Ability to handle busy telephone lines. Ability to organize and prioritize work duties of unit. Ability to problem solve, critical thinking skills. Basic report writing skills. Good written communication skills
Willingly takes on additional tasks as needed or as directed by clinic manager to support the clinic. Initiative and critical thinking skills

Director of Clinical Operations Resume Examples & Samples

Supports Executive Medical Director and DPPM/FO in determining clinical alignment and operational capacity to support initiatives for growth
Teams with DFCI Nursing Leadership to implement the short and long-term strategic goals for nursing at DFCCC
Supports strategies to promote and manage growth in patient activity within DFCCC in collaboration with other Senior Leaders
Participates in DFCCC Leadership Meetings
Acts as the nursing/clinical operations DFCCC representative at internal and external forums
Aligns DFCCC priorities and operations with DFCI’s overall vision, mission, and strategy
Directs clinical operations of all sites, in active collaboration with the Executive Medical Director and the DPPM/FO, and ensures that care is carried out in a manner that promotes optimal patient and family-centered care
Contributes to collaborative review of care protocols with the Executive Medical Director, DFCCC physicians and Disease Center Champions, and ensures alignment with care teams as needed
Maintains knowledge of clinical industry standards for physician practices and disseminates knowledge to appropriate stakeholders
Supports process and performance improvement for patient facing-initiatives, such as scheduling and patient flow
Acts as a local interface and provides operational guidance to the clinical research, labpharmacy, and nursing resources supporting DFCCC
Ensures that patient experience standards are in line with the standards established at main campus and are consistent across all sites
Evolves patient access, in collaboration with the DPPM/FO
Supports patient advocates on clinical matters when needed, in collaboration with the DPPM/FO
Manages all clinical IT functions, including the EMR program and McKesson Specialty tools; integrates tools with DFCI reporting needs
Monitors site-based medical record audits and reporting, and relays EMR audits to DFCI
Provides an active voice in setting the budget for clinical resources (nursing, physicians, nurse practitioners, etc.) to ensure that budget and finance requirements align with clinical needs, in collaboration with Executive Medical Director, and DPPM/FO
Shares accountability for meeting budget targets, cost reduction goals, and performance improvement, along with other targets related to areas of responsibilities
Ensures all clinical operations are compliant and aligned with the operational needs of DFCCC finance and operations policies
Works on clinical quality payor initiatives in collaboration with the DFCI Contracting Department
Reviews payor policies related to any treatment requirements in collaboration with DFCI support
Develops systems for monitoring quality and implements methodologies to assure compliance with patient care standards in collaboration with DFCI Compliance/Quality support resources
Participates in regulatory work including PQRS, Medicare Advantage Risk and insurer audits, and other requirements as needed
Coordinates participation in QOPI, NCQA (Patient-Centered Medical Home) and other clinical quality initiatives
Ensures pharmacy policy adherence by working with the DFCI Pharmacy resources
Ensures the development and implementation of clinical educational programs that meet the educational needs of staff and offer opportunities for ongoing professional development
Supports clinical site leaders in team/leadership development
Works with leadership to establish, implement and evaluate performance standards/expectations for the clinical organization
Implements plans to achieve Magnet accreditation, under guidance from Nursing leadership
Collaborates with network leadership to determine “metrics that matter” for judging success (e.g., referrals/indirect margin vs. direct margin) with input from DFCI leadership
Provides input on, implements, and reports on clinical metrics of DFCCC, including: patient engagement, and clinical quality/safety such as patient satisfaction, pharmacy trends and costs, staffing levels, and medical error reporting
Carries out performance management process set by DFCI throughout clinical operations staff
Oversees Project Leader EMR, Clinical Operations Administrator, Director of Nursing, and Nurse Practitioners
Collaborates closely with DFCI resources dedicated to support DFCCC Laboratory, Compliance/Quality, and Pharmacy
Matrixed oversight of Clinical Research
Clinical Education & Experience

Clinical Operations Coordinator Resume Examples & Samples

Completing initial reviews of formulary exception medication or product requests based on established approval criteria
Data entry of Formulary Exception request information into Sharepoint
Ordering of products and medications on behalf of dialysis facilities
Drafting written responses, correspondence, emails, and spreadsheets as required
Monitoring patient information and records to ensure that all documentation is created and maintained accurately and in accordance with HIPAA regulations
Answering phone calls from facility teammates, doctors, and external vendors with professionalism and courtesy
Triaging calls appropriately and providing problem resolutions where applicable
Ensuring metrics and service standards are met for optimum customer experience
Evaluating helpdesk processes and procedures, and suggesting methods to improve operations, efficiency and service
Handling confidential information with sound judgment
Being knowledgeable and providing consistent communication of DaVita’s standardized policies and procedures for the Formulary Exception process
Assist with special projects as assigned by Clinical Operations management or its partners Other duties and responsibilities as assigned
Able to work overtime with little or no notice as needed
Attend team meetings, phone conferences and training as needed
Know, understand, and follow teammate guidelines, employment policies, and department or company procedures Travel required: up to 10%
Demonstrated ability to write reports and correspondence with clarity
Demonstrated interpersonal, collaborative, and relationship-building skills; ability to interact positively with teammates at various levels across the company
Demonstrated professionalism and courtesy in responding to phone calls and emails
Ability to speak effectively before internal and external groups; ability to effectively present information and respond to questions

Supervisor of Clinical Operations Resume Examples & Samples

Facilitates the employment, development and management of employees
Represents clinic at public and professional meetings and conferences
Participates in clinic communication and public relations programs
Performs other related duties which may be inclusive
Bachelor degree in health or business administration required. (4 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor's degree)
Knowledge of human resource management practices including supervision and staff development
Skill in exercising initiative, judgment, problem solving, decision making
Skill in organizing work to achieve clinic goals and objectives
Ability to monitor compliance standards
Supervisory experience within a clinic setting
Knowledge of health care administration, clinic philosophy and policies and operating procedures

Manager Medical Clinical Operations Resume Examples & Samples

Participates in "ride-along" / audits with the Community Health Workers during field visits with members
Develops solutions to address new, often complex customer requirements that address operational, clinical and customer needs
Active, unrestricted RN license in your state of residence OR Masters degree in Healthcare related field
Minimum 2 years of Case Management experience
Minimum 2 years of Leadership experience
Must live within a commutable distance in NYC or Long Island New York
BSN if RN applicant
Strong team building, leadership and mentoring skills
Field based or Community based experience
3+ year previous supervisory or management experience (including performance management functions i.e. hiring, performance evaluations, corrective action plans, etc.)
Experience working for an insurance company or other managed care setting
Experience working with the Medicaid population

Director of Clinical Operations Resume Examples & Samples

Strategize, develop, and direct operations of the health services department to ensure provision of high quality, cost-effective medical services
Development and management of budget related medical care, P&L involvement
Directly lead, supervise, and develop the health services leadership team and maintain accountability for clinical team development and performance
Ensure compliance with State and Federal regulations, as well as company policies and procedures
Coordinate plans with the local and national quality committee to comply with CMS regulations and National accreditation agencies
Strategize with the senior staff regarding program expansion, business development, new care models
Collaborate cross-functionally to meet goals and objectives and drive staff efforts in implementing activities to meet business goals
Develop and routinely update comprehensive medical management work plans/programs to ensure revenue accuracy
Focus on quality improvement, utilization and appropriately reduce medical costs while incorporating the skills of provider partners whenever possible
Strategize and evaluate methodologies for program adaptation and integration within partnering organizations
Conduct meetings with selected partners to promote program visibility, and support dynamic, results-oriented relationship with selected organizations, contracted facilities, or associated consortium or corporation
Occasional travel to meetings and make market visits as needed to evaluate, educate, and promote initiatives
Nurse Practitioner license - current and unrestricted in your state of residence
3+ years of Nurse Practitioner experience
3+ years of leadership and management experience in an organization that serves the elderly or chronically ill populations
Experience with Medicare, Medicaid or managed care in a variety of health care settings
Strong negotiation skills, regulatory experience and knowledge of basic business principles
Leadership experience with effective team building and quality improvement programs
Demonstrated success working across functions and businesses to achieve business goals
Able to travel on an occasional basis

Director of Clinical Operations Resume Examples & Samples

Master’s Degree in Business, Healthcare, or other related discipline
Lean Six Sigma training or Black Belt
Background in business office management, healthcare IT and facilitation of teams and project management experience
Demonstrated knowledge utilizing telephony software helpful
Credibility and influence skills; results oriented; conceptual; analytical with proven problem solving skills
Proficiency with key PC software including but not limited to Word, Excel, PowerPoint, Access, and Microsoft Project
Previous experience as an RN or working closely with RNs

Senior Global Clinical Operations Lead Resume Examples & Samples

Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members
Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner
Accountable for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
Oversee and coordinate the work of assigned support Clinical Trial Associate(s) and Clinical Scientist(s) at the study/project level ensuring clear delegation/assignment of duties are documented
May function as a Lead CS on one or more projects. Additional responsibilities of a Lead CS may include: contributing to project level documentation, coordination and consistency of activities across TM studies within a project, development of program specific standards, assisting in the coordination of TM related submission documents, and attending and participating in project team meetings, as required
Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned
At least 6+ years experience in clinical trials / drug development
Extensive knowledge of Good Clinical Practice
Track record of successfully managing multiple concurrent phase I and IIa, complex clinical trials
Demonstrated leadership and problem-solving skills
Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities
High level of customer orientation awareness and focus

Global Clinical Operations Lead Resume Examples & Samples

In collaboration with the Medical Expert and CTT, manage the ongoing medical/ sci-entific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are trans-ferred/available in a timely manner
Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear del-egation /assignment of duties are documented
Act as a mentor to support the training and on-boarding of new CS&I associates
Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned
Identify areas for process or technology improvements
Responsible for following best practices and standards for trial management within TM; expected to share lessons learned
Approximately 3-6 years experience in clinical trials / drug development
Track record of successfully managing multiple Phase I and IIa clinical trials concurrently
Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities
Clear written and verbal expression of ideas, an active/proactive communicator
Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships

Associate Clinical Operations Lead Resume Examples & Samples

Support the global multidisciplinary Clinical Trial Team (CTT) to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices. Undertakes defined responsibilities delegated by the Clinical Scientist (CS), including regional management of study conduct, and/or vendor oversight of study related tasks
Attend CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines and quality standards
In collaboration with outsourcing/planning/feasibility personnel, CTT members, local country office representatives and CRAs, support the identification sites and manage study set-up, including support for organizing Investigator meetings or Site Initiation meetings
Interact with investigator sites and CRAs/CROs/vendors and support CS to ensure smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised
Contribute to the development of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents
Support CS in ordering and management of clinical trial materials, including investi-gational medicinal product, CRFs, laboratory kits, and other clinical supplies
Regularly update all trial information databases in order to manage accuracy of in-formation. Including internal CTMS systems and external databases according to Novartis disclosure policies and individual country regulations
In collaboration with the Medical Expert and CTT, support the ongoing medical / sci-entific review of the clinical trial data, and the data analysis. Assist in data review and interactions with the Data Manager, Statistician, and any third parties to ensure high quality data are transferred/available in a timely manner
Support the Clinical Study Report writing; either by directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
Support the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
Assist in the preparation of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved
Receive on-the-job training for any tasks not previously conducted
Responsible for following best practices and standards for trial management within TM; expected to share lessons learned, with CS&I management support
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist in the training for CTAs
Approximately 1-3 years experience in clinical trials / drug development
Good interpersonal skills, ability to successfully interact with and influence with a wide range of people
Customer orientation awareness and focus
Experience of working successfully in a team and managing multiple priorities

Shared Clinical Operations Director Resume Examples & Samples

Bachelor degree
10+ years experience in clinical research or statistics in the Medical Device or Pharmaceutical industry (Graduate degee will subsitute for 2 years of experience)
7+ years of progressive leadership experience in functional area or related field
Bachelor degree in a medical, scientific, or statistical field
MBA or advanced degree in Statistics or Biostatistics
Expertise in state-of-the-art data manipulation and statistical analyses
Proficiency with SAS, familiarity with specialized statistical software (e.g., R, East, Seqtrial)
Demonstrated ability to execute effectively to achieve business results through motivating and holding individuals accountable to deliverables
Understanding of dynamic clinical research environment including global regulations and policies
Experience in resource and budget/expense management
Excellent interpersonal and problem solving skills
Demonstrated ability to execute decisively, proactively monitor progress, identify issues and intervene to remove obstacles and redirect
Ability to drives process excellence and compliance with product/service quality standards
Demonstrated ability to work with FDA and other regulatory agencies and bodies
Demonstrated use of business and financial measures

Clinical Operations Liaison Resume Examples & Samples

Creates sound strategies and best practices at the study and program level to effectively recruit and retain patients, investigators, and sites for clinical trials
Creates strategies to bring efficiencies to the clinical trials management processes, by reducing time surrounding patient recruitment activities
Provides strategic, operational, project management and continuous process improvement oversight for all enrollment and retention activities for assigned projects
Strong understanding of clinical trial processes, experience with country and site selection, trial feasibility and vendor management
Customer focus, strong relationship management, attention to detail, experience with information systems and clinical trial intelligence and supporting data,
Knowledge and expertise in managing business relationships and partnerships

Clinical Operations Liaison, Southeast Region Resume Examples & Samples

Leads study team discussion and recommendations for how to manage non-enrolling sites
Establishes a coordinated outreach to physicians, patient communities, and health care advocates
Interprets and translates epidemiological and clinical trial competitive intelligence data as it relates to recruitment potential for other clinical study team members into actionable solutions
Strong analytical competencies
Must be able to travel an average of 50% dependent on business needs, both domestically and internationally

Clinical Operations Liaison, Northeast Region Resume Examples & Samples

Collaborates with internal and external stakeholders, including study site personnel to understand the patient journey as well as the recruitment opportunities associated with achieving the enrollment goals clinical trials
Assist study teams in the development of targeted patient recruitment material
Facilitates sharing of strategies and best practices across study teams and therapeutic areas
Educates and motivates site staff to effectively recruit patients, and improve patient retention through site optimization strategies
Bachelor’s degree in scientific discipline or health related field
Strong understanding of the pharmaceutical industry, with 5+ years of experience in Clinical Research with a minimum of 5 years experience in global clinical trial execution or site relationship management with a preferred emphasis on enrollment and retention. Candidates with a background as a Study Coordinator or as an MSL, encouraged to apply

Clinical Operations Internship Resume Examples & Samples

Perform Trial Master File reviews, as needed
Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts as directed
Responsible for data tracking to support generation of project metrics and other initiatives
Strong interpersonal, organizational, and multi-tasking skills

Executive Assistant, Clinical Operations Resume Examples & Samples

Manage the administrative priorities of senior executives, some direct reports and consultants
Maintain executive and team calendars by planning and scheduling meetings, conferences, teleconferences and travel
Anticipate and assemble information and data packages for business travel and other department and company events, including meeting schedules, agendas, appointments, and presentations
Conserve executive's time by reading, researching, and routing correspondence; drafting letters and documents; collecting and analyzing information; initiating communications
Manage external interfaces, including directing phone calls, retrieving voice mail, managing E-mail, establishing and maintaining calendar and scheduling conference rooms
Record and distribute meeting minutes and maintain files
Prepare, process and follow through on expenses, purchase orders and invoices. Assist with budgeting process, where needed
Accountable for on and off-site meeting planning and organization (including all travel logistics, booking venues, attendee lists, conference rooms, lodging, catering, meeting materials and coordinating with external vendors)
Ad hoc projects, as assigned, including involvement in Board meetings
Provide back-up support to other executive admins as needed
Some degree of travel may be required
Minimum of 7 years of experience as a Senior Executive Administrative Assistant. Strong computer skills within the MS Office Suite, including Power Point are mandatory
Must have a BA/BS

Assoc Dir, Clinical Operations Resume Examples & Samples

Process development and standardization
15+ years of experience in the pharmaceutical/biotechnology industry
Experience in clinical site monitoring and clinical study management
Experience in process development/management and SOP writing
Past experience in process improvement initiatives and ability to drive change management/implementation, and process changes as these relate to improving business performance
Strong leadership and vendor management skills
Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors, and consultants
Ability to work effectively within a team matrix as well as independently
Financial management skills as applicable to oversee initiative and system expenditures

Clinical Operations Associate Resume Examples & Samples

Minimum one year experience with computer hardware and software applications
Familiarity with PC-based computers and standard software packages including e-mail, word processors, spreadsheets and databases
Familiarity with network navigation and file saving conventions
Experience in moving/copying files and folders

Clinical Operations Risk Manager Resume Examples & Samples

Protocol Review: Review clinical study protocol and amendment drafts; increase program/organization consistency and drive the finalization of Quality by Design (QbD) documents
Coordination of RBM activities
Minimum of bachelor’s degree
Candidates must be US based (WFD or LVL desirable)
Minimum 4 years of experience in clinical operations at a pharmaceutical company or CRO
Knowledge (ICH-GCP and EU directives) and experience of clinical trial conduct and methodology
Demonstrated ability to apply critical and strategic thinking, and distinguish relative importance to resolve issues
Therapy area experience over a number of therapeutic areas
Experience in Risk Based Monitoring (desirable)
Must be able to work and manage time independently, but also has to work effectively as part of a team
Ability to multitask and work on several assignments simultaneously
Must possess and ability to assert self and drive engagement with development teams
Able to lead and facilitate efficient meetings
Constructive interaction with inter and intradepartmental team members
Good written and oral communication skills in the English language
Able to develop and deliver (technical) training
Excellent communication skills with the ability to summarize complex information
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Senior Mgr, Clinical Operations Resume Examples & Samples

Managing all aspects of study progress from start-up to close-out activities, and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs
Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing
Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals)
Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments)
Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team
Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality
Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution
Contributing to individual and team development through training initiatives and team building activities

Director, Global Clinical Operations Resume Examples & Samples

Reporting to the Head of Global Clinical Operations, this position is responsible for the overall management and direction of the clinical research program to ensure development and approval of new products and to ensure that existing products maintain marketability. This position provides leadership for the assigned program in developing clinical operation standards, planning, data analysis, and reporting outcomes to management. Ensure that program and study plans meet regulatory submission standards. Collaborates with other functional areas, CROs, and vendors to meet program and study needs
Reviews clinical data, analysis and medical observations to arrive at sound conclusions. Provides expertise in developing the overall clinical program operational strategy and ensures that program specific standards are developed and applied across trials to ensure consistency
Directs the preparation and establishment of Master Services Agreements and Task Orders with CROs. Directs and manages the preparation of clinical study reports
Ensures that assigned team members receive appropriate team level training and develops program level training materials as needed
Overseeing, managing and approving interactions with internal product development teams and (CROs) related to the planning and development of clinical research projects and conduct of clinical trials
Review, evaluation, analysis, reporting and presentation of moderate to highly complex clinical data
Directs and manages operational study designs and oversees implementation in order to meet established budgets, goals, and milestone schedules. Assists in clinical operations resource planning. Coordinates and supports program level inspection readiness strategies in preparation for and defense of global regulatory filings
Minimum of a Bachelor's degree (or equivalent) and minimum of 8 years of experience. However, a combination of experience and/or education will be taken into consideration
Expert knowledge of the pharmaceutical industry, disease management, drug and device law, industry and government trends is required. Comprehensive knowledge of FDA and International Agency guidelines, SOPs, GCPs, GMPs, GLPs and GXPs
The successful candidate must have significant experience in managing multiple projects. Must demonstrate strong skills in forming and leading the clinical program team and working with other functional areas and external stakeholders (i.e. clinical investigators, CRO & Vendor personnel, etc.)
Minimum of five years clinical operations supervisory or management experience
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Up to 25% Domestic and International travel is required

Supervisor Medical Clinical Operations Resume Examples & Samples

Supports non-clinical operations for a team of commitment and SME staff, support service model performance expectations (assessing performance, staff planning, implementing performance plans, coordinating, monitoring and evaluating)
Takes lead role in setting direction and participating in or developing new programs or initiatives to improve performance of the team
Sets direction for the call center SME and commitment team, resolves problems and provides guidance to members of the team
Ensures that the SME and commitment team meets established performance metrics and performance guarantees
Coordinates, supervises, and is accountable for the daily activities of business support, technical support and production for the team
Sets priorities for the team to ensure task completion
Ability to collaborate with peers and Managers to improve service model performance
Develops plans to meet short and long term objectives
Identifies and resolves operational problems using defined processes expertise and judgment
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
Will be responsible to take incoming escalated calls, therefore must have proven ability to de - escalate consumers and the flexibility to support the inbound supervisor line between the hours of 7 am - 8 pm CST
Ability to analyze data to identify performance gaps and determine a solution to close the gaps
Ensures audits are conducted, standards are met, successful outcome are achieved
High level of professionalism with the ability to interact with high level executives and present information to them
Provides process and technology expertise and support to nursing and support staff
Supports excellent employee performance by mentoring staff, encouraging staff development, and assist with team member Human Resource activities
Enjoys working in a fast paced environment and must be able to adapt quickly to change while executing efficiently
2+ years Management, Supervisory, and/or Leadership background
2+ years’ experience in the health care industry including clinical experience, Medicare/Medicaid, insurance, health promotion, and operations
Intermediate computer proficiency (Microsoft Word, Outlook, and Internet with Excel being a plus!)
Ability to work flexible hours, Monday – Friday, to support the inbound supervisor line between the hours of 7am - 8 pm CST
Remains optimistic, upbeat, and enthusiastic in times of challenge and constant change
Previous call center experience is a plus
Prior experience growing and developing staff
Demonstrated ability with developing strategic plans, attaining goals, driving performance, and achieving targets
Self - directed worker
Leadership and mentoring skills

Clinical Operations Leader, CPS Resume Examples & Samples

Carefully weigh the priority of project tasks and direct team accordingly
Ability to negotiate and influence with diplomacy in order to achieve results
Ability to proactively identify and solve problems by using logical, systematic approach
Strong customer focus, ability to interact professionally within a client organization
Commitment to high quality work and respective consistent performance
Good learning ability
Action orientated
Excellent presentation skills
Proactive issue identification and resolution
In-depth understanding and experience in the clinical trial process
Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word
Competent in written and oral English and fluent in relevant local language
Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical research
Experience in Coordination of Clinical Trials – preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar role
Individuals should have a strong understanding of the cross functional activities

Clinical Operations Lead Resume Examples & Samples

Develop and implement the Clinical Operations Quality Management Plans (QMP’s) including the oversight of vendors and contractors assigned to regional or global UT studies
Manage ongoing data review pertinent to the QMP
Develop reports that highlight concerns and outline action plans
Collect and analyze qualitative and quantitative results from oversight visits
Communicate concerns arising from oversight visits to appropriate clinical staff
Address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified
Provide on-site training for monitors and site staff as needed
Assist in the development and presentation of continuing education based on findings from oversight visits
Conduct QC assessments to verify selected study documents are complete and correct
Collaborate with GCP Compliance/QA to identify trends resulting from GCP Compliance/QA audits
Identify areas for process improvement
Support clinical team in preparing for external audits
Support clinical team by providing input into the generation of timely and appropriate audit responses
Maintain strong working knowledge of SOP’s
Maintain strong working knowledge of ICH-GCP, regulatory requirements and guidelines
Provide staff support by being a contact point for information and advice relating to ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
Provide and deliver training concerning ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
Design, develop and implement clinical training programs within Global Clinical departments
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
Proficient in EDC and CTMS

Johnson & Johnson Global Clinical Operations Resume Examples & Samples

Define a project charter, work plan, and key deliverables to support delivery of business case approved at RDMC in consultation with Head of GCO and Transformation Leader
Define requirements for team members & onboard team members selected in consultation with Head of GCO, Sector Clinical Operations leads and Transformation Leader
Manage cross-sector, cross-functional team to drive deliverables agreed upon in project charter
Maintain strong interaction with key stakeholders within and outside Clinical Operations
Act as a “change agent” for the project, proactively communicating changes to relevant stakeholders, providing feedback and addressing potential barriers to change
Measure and track operational performance and delivery of project milestones, identify and escalate issues to project management
Work closely with Transformation Leader and other work stream leads to identify dependencies across program
Provide coaching, mentoring and feedback on work stream member performance during project
Strongly demonstrate leadership behaviors in alignment with Leadership Imperatives
Foster an environment that encourages the challenging the status quo, sharing of ideas, information, and best practices (internal and external to the organization)
Define quick wins to enable the capture of early opportunities
Lead the design and implementation of an Enterprise demand, resource planning, & alliance management capability which includes demand management, resource (supply) management, alliance governance and reporting

Clinical Operations Specialist Biospecimen Management Resume Examples & Samples

Seeking entry-level candidates
Requires Bachelor's Degree in life sciences with 1-2 years biorepository or biosample operations work experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Must have demonstrated understanding of basic principles in clinical research and biospecimen processing procedures involving blood and tumor biopsies
Needs basic computer skills in Microsoft Office
The TD Operations group provides biospecimen management for client-sponsored biomarker clinical trials in hematology/oncology and inflammation/immunology
Seeking individuals to help support our biospecimen management activities with moderate supervision
This involves using software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures
This individual will also follow up and resolve discrepancies through communication with study teams, clinical sites and CROs/vendors within specified timeframes
The ideal candidate is a team-player who is detail-oriented; can successfully multi-task, supporting several projects simultaneously; knows how to identify/recognize issues and propose solutions with moderate guidance

Associate Clinical Operations Specialist Resume Examples & Samples

Coordinate with CRO CRAs to ensure readiness of Sites for initiation and upload all required documents into Document Management System (CREDI)
Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF): Customize the country level TMF TOC (table of contents) and prepare TMF TOC for site level and ensure all the documents are uploaded / maintained in country level and site level TMF. Follow up with CRO CRAs at agreed frequency for countries and sites TMF documents. Follow TMF oversight plan and develop/ maintain appropriate documentation
Support in Vendors and country coordination: Support CPM in collecting key trial information from external vendors and countries involved in trial execution. Ensure all data is reported to the Clinical Trial Team and in the Novartis databases (CTMS, CREDI) and available to customer. As required set up study related meetings and follow up with meeting minutes
Track trial progress up to site and country level, ensure CTMS is up to date, report to customer as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM)
Good technical and organizational skills (Excel, PowerPoint)
Details oriented
Thorough knowledge of Good Clinical practice
Ability to establish effective working relationship in a matrix and multicultural environment
Presentation and diplomacy skills
Willingness to act accountably in project/trial management

Senior Director of Clinical Operations Resume Examples & Samples

Successfully collaborate on designing, implementing and monitoring effective physician practice and clinic operations
Present to senior leadership on a regular basis the ongoing clinical improvements implemented across the subspecialties
Establishes and maintain relationships with physician leadership, physicians, administrative leadership, and advanced practice providers
Direct supervision of clinical staff such as medical assistants, registered nurses, patient schedulers
Oversee various elements of the revenue cycle as it pertains to clinic operations to ensure optimal medical service collections
Collaborate with centralized front desk and call center management to optimize the patient experience
Ensure the clinics are compliant with Department of Surgery and Baylor College of Medicine policy and procedures
Manage Press Ganey and Meaningful Use initiatives
Establish key performance indicators (KPI) to track and report on a monthly basis
Provide guidance and administrative support for the Clinical Practice Committee
Build upon the current policies and procedures as needed

Global Head, Clinical Operations Resume Examples & Samples

Establish and implement the vision and strategic direction for Global Product Development’s Clinical Operations organization
Accountable for the successful design and implementation of Product Development’s Organizational Effectiveness initiatives, including the design and development of transformational drug development strategies
Accountable for the evolution of the Clinical Operations and Product Development Procurement organizations; identifying opportunities to improve efficiency, delivery and partnership with internal and external stakeholders
Enable effective collaboration across all Product Development functions and with key internal partners including Pharma and Research and Early Development (pRED and gRED), Global Product Strategy, and Technical Operations
Support external collaborations and strategic partnerships to foster innovation and smarter drug development
Directly manage a team of Vice Presidents/VP equivalents and Senior Directors; develop the Clinical Operations, Product Development Procurement and Organizational Effectiveness talent pools and proactively manage succession planning
A proven leader with 10-15 years in the pharmaceutical industry, focused in early and/or late stage development

Director of Clinical Operations Resume Examples & Samples

College degree in the life sciences required; MBA preferred, or equivalent business experience is desirable
Minimum 15 years experience in the CRO/pharmaceutical or related industry
Line Management experience preferred
Strong analytical, interpersonal and verbal/written communication skills
Demonstrated ability to manage large, complex projects on time and within budget
Ability to express complex technical concepts effectively, both verbally and in writing, to diverse groups of people
Ability and willingness to independently travel up to 40% globally
Ability to work in home office remotely or at Headquarters-Hinckley, Ohio/Frederick, MD at times

Clinical Operations Consultant Resume Examples & Samples

Lead clinical trial project execution for oncology programs to ensure that trial timelines, costs, and quality metrics are met
Develop and manage Clinical trial timelines for the conduct of the clinical trial protocol
Serve as primary contact for functional area representatives in managing protocol execution
Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments
Forecast and oversee all clinical supplies, eg, study drug
Manage study milestones to ensure accurate tracking and reporting of study metrics
Oversee ongoing service provider management (eg, CROs, IVRS, central labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution
Create and manage clinical trial budgets in collaboration with the Vice President of Clinical Operations
May provide leadership, guidance and mentoring to CRAs and CTAs
Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidances and in adherence to SOPs, ICH/GCP, and local regulations; participate in ongoing process improvement initiatives
Participate in clinical operations initiatives and programs
Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork
Perform other duties as assigned or required
Bachelor’s degree with at least 5+ years of oncology CRA experience for the manager level, with at least 1 year of staff management experience. Immuno-oncology. The senior manager level requires 8+ years of combined CRA and CTM experience and 3 years direct staff management experience
Broad and current knowledge of regulations, clinical development process, and oncology
Proven leadership skills to direct protocol execution to ensure timeline, budget, and quality metrics are met
Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate
Experience developing trial plans, including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
Excellent organizational and negotiation skills. Proven ability in creative problem-solving; possess sound judgment
Team oriented – collaborate effectively with the Clinical Operations study team, cross-functional team members, and external partners
Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook
Working knowledge of MS Project for development and update of clinical study timelines
The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment, and needs to occasionally move about the office for meetings and to access files and other office equipment
Willing to travel – anticipate up to 25%

Comp Stroke Clinical Operations Resume Examples & Samples

Minimum of 3 years clinical healthcare experience required
Experience working in a certified Primary or Comprehensive Stroke Center preferred
Experience in caring for stroke patients preferred

Mgr Clinical Operations Resume Examples & Samples

The Operations Support Manager assumes shift responsibility for evaluating, coordinating, and maintaining a safe and effective operation of hospital-wide activities 4pm-8am Monday through Friday, all day Saturday and Sunday, holidays and additional days leadership is out of the hospital
Assists in the development of systems to enhance and evaluate effectiveness of patient care delivery and hospital operations
Performs the role of bed management coordinator (BMC) by managing the assignment of patient care beds within the hospital
Reinforces set staffing and operational guidelines established by the Director
Practices effective and professional communication techniques with all interactions
Enforces and assists in the interpretation of hospital, departmental, and medical staff policies
Acts as a clinical resource and consultant to all staff
Maintains awareness of his/her own educational needs and plans for participation in continuing educational programs as necessary
Ability to communicate effectively (verbal, written and electronic)
Ability to demonstrate analytical and critical thinking abilities with proactive decision making and negotiation skills
Proficiency in the use of MEDITECH system
RN with current state licensure
Graduate from an accredited school of Nursing, BSN preferred
Minimum 5 years nursing experience in acute care setting with no less than 1 year in a Charge Nurse/Nurse Manager capacity preferred
Current BLS through American Heart Association required
Current ACLS through American Heart Association required within 90 days of hire

Director of Clinical Operations Resume Examples & Samples

Lead, provide authority, accountability for and coordination of the nurse executive and clinical administrative functions
Define and support the hospital’s mission, vision, values, goals and objectives by demonstrating concern for quality, patient safety, productivity and responsiveness by self and those managed
Plan, implement, revise and delegate nursing care with patient safety as the primary goal
Play an active role in advocating quality and patient safety
Promote recruitment, retention, continuing education, community involvement, and development of nursing staff members and evaluate the recruitment and retention program for clinical areas
Improve the quality of the products or services provided and implement methods to increase their efficiency and productivity
Support the philosophy of the Department of Nursing and promote the profession of nursing by articulating nursing values, maintaining the integrity of the profession and its practice and by striving to shape social policy
Participate in development and evaluation of professional practice by participating on unit and/or hospital committees, special projects and attendance at staff meetings and town halls
5 years of recent and progressive management
5 years of administrative experience preferred

Clinical Operations Consultant Alaris Infusion Resume Examples & Samples

Home-based position with up to 75-100% regional travel (typically 1-4 days of overnight travel a week). The ideal candidate will reside in the Columbus area but other locations near a major airport will be considered.**
Demonstrates thorough knowledge and understanding of relevant clinical operations, products and services
Participates in or leads clinical pre-sales support, assessment and evaluation of new products and services
Participates in or leads the post-sales assessment, design, implementation and monitoring of new products and services
Develops, plans and manages customer training programs
Serves as lead consultant and resource to internal and external customers
Makes recommendations that will drive customer acceptance and utilization of new products and services
Identifies and communicates opportunities for product improvement using direct customer feedback
Undergrad degree required; Advanced degree preferred
Current active RN license with experience in clinical hospital nursing
4-6 years of experience in related field
Prior leadership role in nursing preferred
Nurse educator experience a plus
Ability to travel 1-5 days every week required
Upon hire, must provide proof of, and maintain current immunizations and obtain additional immunizations appropriate for the facility which enables access to customer sites in order to perform essential job functions. Proofs must include: Hepatitis B, Influenza (current year), MMR (mumps, measles, rubella), Varicella (chicken pox) Annual TB/PPD (skin test), Tetanus/Diphtheria/Pertussis

Data Analyst Clinical Operations Resume Examples & Samples

Proficient in SQL (Toad or PLSQL Developer)
Strong organizational/problem solving skills
Working knowledge of Microsoft Excel including complex formulas, pivots and charts
Associate’s or Bachelor’s Degree of Art or Science
Understanding of VBA in Excel

Clinical Operations Specialist, CPS Resume Examples & Samples

Client focused approach to work
Experienced in dealing with confidential materials
A flexible attitude with respect to work assignments and new learning
Ability to liaise with Senior Management within both PAREXEL and client companies in a professional manner
Excellent PC skills, with working knowledge of MS Outlook, Word, advanced Excel and PowerPoint
Proven experience in similar role

Clinical Operations Director Resume Examples & Samples

Assures clinics perform with high standards of care, measure and improve clinical work flows, and implement standard best practices
Ability to lead and manage for multiple clinic locations
Manages clinical space utilization and requests for multiple clinic locations
Oversees and evaluates clinical equipment needs and requests
Works with leadership of the PBS revenue cycle, PRC patient access, nursing and front desk
Promotes practice growth and collaboration with medical practices and sections with BCM, CHI/St. Luke’s Health System and other affiliated hospitals
Works effectively with the organization’s clinical affiliates (notably, CHI St Luke’s Health System and related clinically integrated networks) to support a functional regional vertically integrated health system
Works in collaboration appropriate teams in preparation of internal and external reporting, budgeting, forecasting, capital budgeting, and financial modeling
Monitor patient satisfaction reports and results (Press Ganey and others) and develop plans by which clinical operations teams can contribute to the improvement of our health care facilities
Uses performance improvement techniques to build culture and improve all aspects of operations and outcomes
Develops, oversees and implements enhancements to practice operations
Assures that the clinical environment in which physicians practice is supportive of Baylor College of Medicine’s academic missions in education and research
Develops and implements clinic communication strategies that inform, link and bond health system physicians and staff
Demonstrates a collaborative leadership style through direct, open and honest communication
Listens and seeks to engage others
Performs other job duties as required
Required: 5 years of appropriate experience

Clinical Operations Analyst, PMI Resume Examples & Samples

BBA, MBA, or MHA in Finance, Healthcare or related field preferred
Proficient in Excel, PowerPoint, Word, and Access, Tableau skills a plus
Solid analytical and problem solving skills are a must. The selected candidate will have a demonstrated ability to synthesize data and interpret data
Excellent interpersonal skills; a dedicated listener, comfortable in a variety of settings dealing with diverse constituencies
The ability to communicate clearly and effectively both verbally and in writing
Ability to work well under pressure effectively managing time and tasks
Works effectively within the department and across departments as a pro-active team member
2-3 years of relevant experience required

Manager, Medical Clinical Operations Resume Examples & Samples

Manages administrative and clinical operations consisting of field based and/or contact center based staff
Manage client relationships
Collaborate with cross functional teams on practice specific strategies to improve Medicare Stars ratings
Work most often impacts a large business unit, or multiple markets/sites, or at the segment/market group level for functional staff positions
Fiscal and operational discipline and management
Customer service management experience
Knowledge of Benefits and Claims Systems and Operations
Strong inbound and outbound telephonic skills
Teambuilding and leadership skills
Computer skills and technical aptitude, familiar with MS Office
Demonstrated ability to perform effective active listening skills to empathize with the customer in order to develop a trust and respect
Demonstrated ability to take responsibility and internally driven to accomplish goals and recognize what needs to be done in order to achieve a goal(s)
Demonstrated ability to turn situations around and go above and beyond to meet the needs of the customer
Knowledge of call center performance measurement systems and metrics (i.e. ASA, AHT, Service Level)
Project/Product coordination/management skills
Medicare Stars experience
Quality or Six Sigma experience

Clinical Operations Dir Resume Examples & Samples

Partnering with Performance Services and Departmental resources to accomplish in depth analyses, measures, targets, and reports
Modeling and projecting to determine expected volumes and number providers needed to maintain and grow Medicine clinical programs
Facilitating process improvements across the Department clinical enterprise
Identifying and isolating billing opportunities, deficiencies, errors, charge corrections, trends, etc
Generation of sub-specialty reports to review sub-specialty revenue, compare provider data, trend growth over time, and isolate any potential billing/payment issues
WRVU analyses and recommendations to clinical leadership
Monitor faculty productivity and access to ensure Departmental/Divisional metrics are achieved
Compensation plan modeling and continuous improvement ideas
Evaluating and analyzing clinic template issues and opportunities
Creating and providing objective data and feedback to faculty
Creating and providing individual and ad-hoc faculty reports as requested (i.e., productivity for a specific unit, service, etc.)
Review all of the monthly dashboards and evaluate opportunities for change
Regular collaboration with Performance Services to further analyze data
Clinic access and scheduling processes in DoM
Investigate and respond to patient/referral source complaints
Lead the coordinated effort across the Department to support Duke Health access improvement and redesign activities
Meet regularly with faculty and personnel and serve as a key member of the administrative team for the Department. Keep physician leaders and practice members informed of administrative issues or changes
Promote the development of a new work force management process, methodology, and standards
Proven innovation and initiative to anticipate, develop, and implement new procedures, practices and processes adaptable to constantly changing work patterns and business methods, to solve unusual and new concerns using means, which establish effective and efficient precedents
Strong analytical and critical thinking skills to identify problems and develop innovative solutions
Demonstrated ability to analyze complex situations, identify and analyze problems and develop options and recommendations for resolution
Demonstrated ability to interpret policies and procedures and to propose solutions to problems and apply solutions to non-recurring or precedent setting situations
Proven ability to develop, analyze, and carry out project objectives and work well with others of a diverse nature in achieving organizational goals
Proven ability to research, gather and organize information to produce concise reports using various resources
Strong leadership skills and ability to take responsibility for assigned areas, and to gain the confidence of clients and colleagues
Excellent negotiation skills. Demonstrated counseling techniques with the ability to act as a facilitator, exercise diplomacy, tact, professionalism, responsiveness, a high degree of flexibility, and solve concerns between individuals in a fair and equitable manner
Skills, knowledge, and experience in conflict resolution, counseling, mediation
Excellent interpersonal, as well as written and verbal communication skills to interact with a variety of personalities at all levels, exercising tact, sound judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness
Skill at negotiating with various personalities and developing internal and external network of contacts
Proven organizational, analytical and management skills
Ability to act independently and exercise sound judgment, and the acumen and sensitivity to identify matters that require higher level management consultation and/or group collaboration
Demonstrated ability at presenting a positive, professional and helpful impression and working as a team member
Ability to work independently and follow through on assignments with minimal direction

Global Head Clinical Operations Resume Examples & Samples

Define global performance standards for the execution of TCO clinical trials. Provide leadership, direction and communication centered on operational excellence and team effectiveness
Defines global performance standards
Sustainable global resourcing of clinical trials with TCO CTLs and CPAs
Ensure supervision and professional development of the CTLs and CPAs
Ensure that TCO Clinical Operations associates are trained on GCP, clinical trial processes, company processes and SOPs; support CPLs on mandatory trainings
Constantly challenge the status-quo and identify innovative solutions and improved processes for a more efficient and streamlined clinical trial execution
Build TCO Site Network that is capable of molecular screening, collaboration and timely execution of TCO clinical studies including FIH and Phase II trials; coordinate the appropriate allocation of TCO-accredited sites to these studies
Provide input and recommendations for budget, resources and timelines to clinical teams and TCO Finance
Coordinate and ensure the delivery of high-quality protocols using an efficient and well-documented process through the TCO PRC office
Support teams in the identification of clinical trial quality-related matters and the development of corrective actions, and monitor timely resolution
Represent TCO (through the Head of TCO Process Improvement and Training) on all quality assurance programs specifically addressing any issues identified through audit activity
Interface with appropriate line units within OGD and GenMeds to ensure process improvement and effective cross-functional communication

Clinical Operations Specialist Resume Examples & Samples

Trial budget management
At least 6 years operational experience of clinical study execution in a pharmaceutical company or contract research organization
Experience in finance: forecast, actuals, cost reconciliation a plus
Strong technical and organizational skills
Demonstrated ability to establish effective working relationship in a matrix and multicultural environment
Demonstrated presentation and diplomacy skills
Strong customer oriented mindset
Willingness to act accountably in project / trial management

Clinical Operations Supervisor Page Rd Orthopaedics Resume Examples & Samples

They will be on the floor in the clinic monitoring performance of the staff and checking with faculty to make sure clinic operations are running smoothly
They will be coordinating coverage if people are sick or on vacation
They will be completing payroll for the clinic staff
They will approve time off for clinic staff
They will be performing chart audits on the documentation the staff do in clinic so they can objectively assess them on performance reviews
They will be making sure providers and staff are meeting MU goals and adding that data to staff performance reviews
They will handle any discipline/issues that come up regarding clinic staff
They will have staff meetings with clinic staff
They will have input into hiring decisions of clinic staff
They will conduct all mid-year and year-end performance evaluations of 30+ direct reports
They will attend Joint Commission Liaison meetings monthly and report information at Full Staff Meetings
They will be responsible for implementing all Joint Commission policies and Performance Improvement projects
Must be present on site for 8 hour shifts during standard clinic hours
Must travel between locations on regular basis
Must be able to push/pull 50 lbs. (push wheelchairs)

Supervisor Clinical Operations Resume Examples & Samples

Supporting the patient through excellent customer service while achieving SM financial goals
Manages the daily operations within the Imaging department including Imaging access, scheduling templates and lean management for staff
Responsible for protocolling of imaging referrals, maintaining department statistics, ordering supplies, managing staff schedules, provides training, ensures overall competency of assigned staff and provides guidance to staff on new protocols
May rotate as an after hour Supervisor on Call for the Imaging Department
Supervises daily operations of Imaging and Breast Care Support staff including coordinating the work activities and maintaining staff schedules
Responsible for Imaging referrals, expedited reports, oversees File Room processes and protocols including imaging result notification and importing/loan outs for imaging studies
Recruit, hire, train and supervise assigned employees to department policies, procedures and protocols
Responsible to ensure accurate charges are entered in IDX and RIS
Identifies and resolves work problems to ensure quality patient service
Responsible for radiology compliance report as well as other reports as requested
Responsible for payroll and associated budge of assigned personnel
High School diploma and / or equivalent required
Strong knowledge of Medical Terminology, ICD - 9 and CPT coding
Good organization, auditing and time management skills
2+ years office management experience; plus one year in a healthcare organization
Ability to meet all health requirements prior to employment and periodically thereafter, as required by company policy, state regulations and physically able to perform assigned job duties

Senior Director / VP, Clinical Operations Resume Examples & Samples

Direct all aspects of timeline/fiscal management, analyses, compliance, and conduct global and domestic clinical trials to ensure delivery of company goals on time, within budget and in compliance with SOPs, FDA and ICH/GCP guidelines with direct involvement at project team level of lead ophthalmology programs
Provide operational and implementation expertise, in collaboration with other members of the management team in strategic planning of clinical activities and ensure translation of strategic decisions into operational plans
Oversee proposals, selection and management of CROs and other vendors for the conduct and management of clinical trials
Manage the preparation and/or review of clinical protocols, data listings, summary tables, study results, study reports and regulatory documents, IND annual reports, IND safety reports, IB, and preparing publications and presentations of clinical trial results
Forecast and manage investigational drug labeling, packaging and distribution as part of supply chain management
Implement integrated safety database effort across all clinical programs
Oversee preparation and submission of safety reports (pharmacovigilance)
Partner collaboratively with key internal functions such as Medical, Regulatory, CMC, and Program Management to implement the Company’s clinical strategies and drive organizational success
Accountable for management of clinical operations and data management groups with direct reports who may include both internal staff and consultants. Ensure optimal workforce planning, retention, coaching consistent with company’s overall human resource growth strategy, and performance management of the staff. Mentor and manage the growth and development direct reports
Maintain collaborative relationships with vendors, key opinion leaders, investigators, and other key individuals as necessary to ensure appropriate program progress and overall business and clinical objectives
Represent clinical operations plans and status to partners and senior audiences, both internally and externally
Effectively partner with Human Resources to conduct workforce planning for implementation of company operational plans and develop a resource-tracking process
Partner with Finance to develop and manage the Clinical Operations budget and update Senior Management with progress and anticipated changes in scope, schedule and resources in a timely manner
Optimize and implement SOPs, processes, communication, & infrastructure within Clinical Operations Department to support company goals including Regulatory filings
10+ years of experience in leading clinical operations teams responsible for successful execution of clinical programs in a pharmaceutical or a biotechnology company
Bachelor’s degree required in science or related field, advanced (clinical) degree preferred
Experience with all operational aspects of a clinical trial program leading to a NDA/BLA
Demonstrated ability to select CROs, set up trials, enroll sites, maximize recruitment, and maintain high quality standards that significantly exceed industry standards
Demonstrated ability to build, coach, motivate and supervise a high performing team in a growing company, including ability to clarify roles and responsibilities. Will be known for open, transparent and fair leadership, teamwork and collaboration, while also driving accountability and results
Excellent team interaction skills along with demonstrated ability to lead and influence others
Ability to demonstrate effective leadership in ambiguous and frequently changing situations
Well-developed critical reasoning skills and in risk management assessments
Outstanding written and verbal communication skills including presentation effectiveness
Independent, innovative, and creative thinker
Proven ability to positively impact company culture and demonstrate flexibility in fast paced environment
Committed to the values of integrity, accountability, transparency, scientific rigor and drive

Clinical Operations Associate Resume Examples & Samples

Serves as a back-up or second point of contact if CTM is unavailable
Acts as secondary point of contact between team members and vendors, and study sites to assist in the conduct of study
Maintains and is responsible for updating data in CTMS and serves as a reference point for CTM department on study status and CTMS management
May manage DSMB/IDMC activities across projects
Collates materials for COA training and investigator meetings as necessary
Requests CDAs and consulting agreements
Participates in tracking and reporting study data for management
Assists in the development of study documents
Accompanies CTM or COA on site monitoring visits
Assists with vendor management and troubleshooting
Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution
Works with other departments to provide and receive required information required for achievement of clinical research assignments, goals and objectives
Participates in process improvement initiatives for the department

Ubc-VP Clinical Operations Resume Examples & Samples

Develops and implements strategies to ensure clinical study objectives are met effectively and efficiently within prescribed performance parameters
Leads the engagement teams as primary executive-level client contact
Must be proactive and identify risks to study timelines and budgets and then develop contingency plans to address outages
Applies clinical trial management expertise to proactively identify potential risks to study timelines and budgets and develop remediation plans to mitigate risks
Manage program issues with UBC team and UBC Management, if required
Partners and influences strategy and development teams to support creation of new opportunities through delivery of client proposals, RFIs, presentations and proposal defenses
Partners with industry experts/consultants/advisors to continually acquire necessary medical/scientific expertise
Interacts and collaborates with staff in the preparation of clinical development plans, protocols, investigator brochures, and medical/clinical reports as required
Represents UBC by publishing scientific or industry related articles in industry journals
Leverages operational management skills across the entire UBC organization by partnering with staff organizations in updating and maintaining Standard Operating Procedures, medical/scientific tools, training and staffing requirements
BA/BS degree; advanced degree preferred
10 years or more of progressively complex clinical research experience in a pharmaceutical or Contract Research Organization Company including management of regional and global programs
Advanced professional degree in the life sciences strongly preferred
Demonstrated success leading global Phase II- IV as well as commercial and post marketing programs
Proven expertise in global clinical trial initiation, maintenance and close out
Demonstrated experience in global leadership of operational teams
Proven efficiency in written and verbal communication skills necessary to meet the needs of various audiences
Demonstrated fluency of interpersonal skills commensurate with the need to work closely with both outside vendors/consultants, team members and support groups and customers
Proven ability in decision making and problem solving skills, and demonstrated abilities to manage through systems and drive innovation
Confirmed ability to drive successful results
Established ability to adapt, works through conflicts, and persuasively influence outcomes
Effectively comfortable with change and is able to lead teams through periods of ambiguity
Fluent ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment
Proven ability to translate client needs into operational excellence
Equally effective providing strategic insight and willing to get into the details
Proficiency with translating abstract concepts into concrete plans
Ability to balance resources appropriately - demonstrate an understanding when employees are stretched too far or not far enough
Ability to evaluate and resolve complex problems and drive for results, yet function effectively within a matrix team environment
Travel to UBC locations and Clients as needed

Supervisor Clinical Operations, Oncology Resume Examples & Samples

Supervises daily operations at clinic site and coordinates the work activities and schedules
Administers clinic policies and procedures in a consistent and timely manner
Recruit, hire, trains and supervises assigned employees
Prepares reports and manages assigned projects, oversees all business related functions including cash handling and daily batch audits and payroll functions
2+ years of medical or business office experience
Electronic Medical Records (EMR) experience
Proficient in Microsoft Office i.e. Word, Excel, and Outlook
CPR or willing to obtain upon hire
AA degree or higher education in healthcare operations, business office, or related field
1+ year of supervisory or team lead experience
Budget, reporting, auditing, and payroll experience

Senior Clinical Operations Coordinator Resume Examples & Samples

Proficiency with PC; advanced Microsoft Word, Excel, advanced PowerPoint, SharePoint databases, graphics and email; social media experience preferred
Ability to coordinate and prioritize all areas of responsibility
Team oriented, works well in a team environment, adaptable and flexible in nature
Excellent and oral communication skills
Up to 10% travel

Manager of Clinical Operations Resume Examples & Samples

Manage overall operation of a Primary Care practice and assures that required policies, systems, procedures and standards are in effect and communicated to Primary Care personnel
Ensures all physical, educational and community support needs of the Primary Care patient and family are met
Oversee day - to - day operation of the Primary Care practice to include scheduling of patient, physician and treatment visits
Use Press - Ganey scores to evaluate and improve patient satisfaction. Implements, tracks and reviews process improvement
Interviews, selects and orients practice personnel and contributes evaluation information on other personnel as appropriate
Normal office and clinic environment, some travel between clinics required
Associates degree (Bachelor’s degree preferred) in public health, business or related field preferred; and / or equivalent and relevant work experience
5+ years of experience in medical practice management, Health Plan Operations or Medical Management
Knowledge of practice management principles, including budget control and cost accounting, professional and patient billing
Ability to create and maintain a caring culture and demonstrate ability to lead groups successfully coupled with strong interpersonal, excellent oral and written communication skills

Director Medical Clinical Operations Resume Examples & Samples

Responsible for the successful financial performance of the owned Practices, including development of budgets and capital projects
Work with the Optum Leadership to execute practice business plans for OptumCare within the Nevada Market
Foster and develop the OptumCare culture among staff and physicians and foster an atmosphere of trust and open dialogue
Develop and promote strong communication among Physicians and Operations staff
Bachelor’s degree in public health or related field; and / or equivalent and relevant work experience
3+ years of experience in a VP or Senior level capacity overseeing medical practice management, health plan operations or medical management positions with successive promotions
Strong financial and operational background in physician practice management
Master’s degree in Health Care Management or related field

Supervisor of Medical Clinical Operations Resume Examples & Samples

Supervises day to day operations of the UR department, ensuring compliance with all applicable regulations, delegation agreements and policies/procedures
Sets priorities for other supervisors and senior staff team to ensure task completion
Monitors work load of team and work load balance as is necessary to meet performance and quality thresholds
Ensures the department meets or exceeds all required standards (e.g. turnaround time; stte, federal and accreditation; application data entry accuracy)
Actively participates in delegation audits performed by clients
Maintains relationships with and oversight vendors
Completes cost containment and quality improvement projects
3+ years supervisory experience
Demonstrated ability to interact positively with internal and external customers
Intermediate Word, Excel, and internet navigational skills
2+ years of related experience in health care or health insurance: UM, eligibility, benefits or claims processing related environment
Supervisory Experience in a production environment
Experience managing a remote staff
Project management/coordination experience

Director of Clinical Operations Resume Examples & Samples

Development and management of budget related medical care
Works with the site medical expense team to provide direction for actions to control targeted costs for inpatient and outpatient services
Conduct regular agenda driven meetings with staff to address issues, concerns, and to communicate corporate and site-specific philosophy
Oversee the integrity of the patient-data base system to ensure consistency in the data entry and integrity
Coordinate quality program and contractual requirements, maintain compliance with regulatory and accreditation requirements
Strategize with senior staff regarding
R.N. degree with active license
5+ years of leadership and management experience in an organization that serves the elderly population
5 years of clinical experience
Experience with Medicare, Medicaid and managed care in a variety of health care settings
Strong negotiation skills, budget management experience and regulatory knowledge
Leadership and management experience in effective team building and continuous quality improvement programs
Master’s degree, ideally in nursing, health sciences, social services or business

Clinical Operations Analyst Resume Examples & Samples

Collects, analyzes and presents data in innovative and consumable ways to support business decision making
Provides technical expertise and clinical development knowledge to Clinical Operations study teams and leadership
Develops solutions to a variety of complex problems and initiatives
Contributes to innovative analytical methodologies and visualizations of the growing data sets available to inform clinical trial design and operational strategy
The senior level may oversee the data analysis of other team members
Develop and deliver business relevant, innovative reports and analyses for use at all levels of the Genentech Research and Early Clinical Development department
Exercise independent judgment and discretion on analyses and analytics projects, and drive the development of strategic solutions
Consult with members of leadership and external stakeholders on the changing landscape of industry standards for Clinical Operations to support current and emerging portfolio needs (e.g., evolving Phase I model, regulatory timeline shifts)
Drive requirements gathering for data visualizations and innovative analyses, and ensure complete understanding of project objectives and action plans
Manage communication with study teams, both verbally and in writing
Validate and model data from internal and external sources (typically in Excel) in support of Clinical Development Liaisons and Clinical Operations study teams
Lead analytic and technical innovation through framework and model development
Oversee ad-hoc analyses using internal and external data sets
Leverage off-the-shelf solutions to develop customized data visualizations
Lead and support business initiatives with analytics and data driven insights
Participate in data source investigation, application development and user acceptance testing
Develop expertise in concepts, methods and supporting technology relevant to analytics

Director of Gred Non-clinical Operations Resume Examples & Samples

Representing gNO on the Safety Assessment Leadership Team
Providing operational guidance for all functions in gNO
Ensuring appropriate training and adherence to regulations/SOPs for GLP activities, business compliance requirements including vendor selection and oversight, and computer system validation as appropriate
Demonstrating familiarity with current regulatory submission processes and guidelines
Ensuring adherence to SEND regulatory submission requirements
Serving as the SA Operational lead as part of Genentech/CRO Executive Leadership Teams
Maintaining accountability for Safety Assessment representation on the Genentech IACUC
Ensuring that project/personnel resources are staffed/allocated appropriately to meet program goals and timelines
Ensuring for internal and external SA studies that protocols and reports accurately reflect the objectives of the study
Serving as a key reviewer on multifunctional governance committees, as needed
Leading operational taskforces, as needed
Providing mentoring and career development for staff

Manager Senior, Clinical Operations Resume Examples & Samples

Manage day to day activities of all aspects of the external studies department for assigned VMSI projects including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
Conduct ongoing clinical research for clinical trials, including planning, execution, and interpretation of research results
Manage clinical operation plan and establishes protocol documents as needed
Manage direct report CRAs including recruitment, training, coaching, assignments, coordination of workload priorities and performance management
Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
Develop and monitor budget
Monitor work to ensure quality, and continuously promote Quality First Time

Supervisor, Clinical Operations Resume Examples & Samples

Supervise Clinical Operations day-to-day work, assignments, training, and service issue resolution; ensure metrics and service standards are met for optimum customer experience
Identify, create, monitor, and maintain key performance indicators including but not limited to teammate productivity, quality audits, and departmental service level agreements
Provide consistent, visible, timely, and effective communication to team on team goals and objectives and progress toward those goals
Evaluate Clinical Operations processes and procedures; suggest and implement methods to minimize labor costs and to improve operations, efficiency, and service to internal and external customers
Oversee patient information and records to ensure that all documentation is created and maintained in accordance with HIPAA regulations and to ensure the accurate service is provided
Assist in the development and implementation of Standard Operating Procedures (SOPs) for all Clinical Operations functions
Participate in requirements gathering and implementation of new IT applications; ensure appropriate relevance of applications or tools for Clinical Operations purpose and teammates
Participate in all daily, weekly, and periodic work/management meetings with peers and senior operations leadership
Review performance metrics with senior operations and DaVita Rx leadership on an as-needed basis
Supervise departmental labor budget and miscellaneous expenses
Maintain absolute compliance with Medicare, Medicaid, and Pharmacy to all applicable regulations via a thorough practice of documentation and organizational skills
Create and maintain positive relationships with the DaVita Rx Pharmacy Operational Directors, Managers, and Chief Pharmacists
Maintain current knowledge of Clinical Operations issues and trends through education, seminars, and research
Travel required: up to 15%, varying by month based on business needs

Dir Phase, Clinical Operations Resume Examples & Samples

Plans for the appropriate study conduct and staffing logistics to ensure a successful weekly Phase I workflow (including volunteer recruitment, clinical conduction, and client deliverables). Assures appropriate and adequate staffing of the clinical and technical operation units
Attends regular standing meetings and key sponsor initiation meetings
Schedules operational and study meetings as needed. Communicates with client representatives on a regular basis to gain feedback
Participates in meetings with senior management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager and supervisor detailing the workload ahead and determining future needs
Participates in and leads work teams in automation to further give PPD a competitive advantage utilizing these technological advances
Regularly participates in weekend coverage as it relates to management oversight of the phase I clinic and is available for client dinners and
Entertainment opportunities as needed
Travels to client companies for business development opportunities. Participates and represents PPD in 1-2 industry conferences per year for the purpose of solidifying client relationships and bringing in new business
Interacts with Business Development for scheduling purposes and to drive business into the unit
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
12+ years) or equivalent and relevant combination of education, training, & experience. Strong background in project management, regulatory, FDA, and ICH guidelines
5+ years of management responsibility
Extensive knowledge of clinical trials
Ability to drive and adjust departmental day to day activities to effectively conduct clinical trials
Attention to detail and ability to multitask
Knowledge of Microsoft Office software
Strong leadership skills and critical thinking skills
Effective time management and project management skills
Ability to lead and facilitate cross functional teams successfully
Ability to act as a liaison with the client, investigator, study team and other departments

Clinical Operations Coordinator Resume Examples & Samples

Associate’s degree in Health Care Administration, Business administration, nursing or related field OR Nursing License
Strong knowledge of Microsoft Office including Excel
Two or more years of clinical operations or primary care office experience
Supervisory experience
Professional Health care License or certification
Current Texas Vocational Nurse License

Clinical Operations Coop Resume Examples & Samples

Supports and/or tracks external access rights to Clinical Trial Management Systems using SharePoint webpage
In conjunction with clinical project team, responsible for review of regulatory documents and verification of other items required to initiate drug shipment
Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, etc
Excellent attention to detail and problem solving skills
Excellent computer skills, including proficiency with Microsoft office and Sharepoint platforms

Manager, Medical Clinical Operations Resume Examples & Samples

Manages and is accountable for clinical and non-clinical professional employees and/or supervisors
Ensures site remains compliance with all applicable regulatory and accreditation requirements (NCQA and URAC)
Current unrestricted RN license in the State of Kansas or License in Behavioral Health
Proficient in Microsoft Excel, Word and PowerPoint
Managed Care/Insurance and/or Medicaid experience
Accreditation requirements (NCQA and URAC)
Telephonic or Field based Case Management experience

Clinical Operations Lead Resume Examples & Samples

Plans and manages Clinical Operations resources in support of VMRD, Quality Control Laboratories (QC), Clinical Development, and other internal customer animal challenge projects balancing both project timelines and departmental budget
Oversee all animal facilities to assure that Quality Control, VMRD, and Clinical Development animal testing remains in compliance with the Animal Welfare Act and corporate policies
Direct the scheduling of animal technicians to support QC and VMRD in vivo animal tests ensuring compliance with Standard Operating Procedures, Company Outlines, Governmental Regulation (USDA and EU), Departmental Policy, GLP’s and GMP’s
Ensures leadership and clear/concise communication both intra- and interdepartmental. Directs the development and training of personnel to enhance effectiveness, coverage and operation efficiency
Plans and implements Clinical Operations plans, policies, and procedures, consistent with strategic goals of the company
Develops and reviews operational objectives with Quality Control Leader for all testing issues
Coordinate studies, facilities, and personnel to ensure that all are used to their fullest capability
Manage programs for animal husbandry that include: health, sanitation, waste management, nutrition, odor, parasite/vermin, procurement, etc
Provide support and training to maintain a safe and accident free work environment
Ph.D. With five years, M S. With seven years, B. S.. With 10 years or equivalent in biological or animal sciences, or related discipline
A minimum of three years management experience including budget and supervisory responsibilities
A thorough familiarity with USDA and EU regulations and AAALAC guidelines
Detailed knowledge, interpretation and application of the specifications listed in the Animal Welfare Act
Extensive experience in the care of laboratory, companion, and livestock animals
Demonstrated ability to perform and reach targeted conclusions
Strong written and oral communication and ability to effectively direct a team of professionals
Ability to establish appropriate timelines to meet project milestones and hold colleagues accountable to timelines and activities
Process and detail oriented with the ability to review and/or prepare detailed structured documents
Ability to develop solutions to routine and complex problems
Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work
Ability to communicate effectively with Team Members to facilitate completion of required activities to meet all deadlines
Five years of progressive and complex animal care and laboratory experience for testing veterinary biological products
AAALAC certification experience
Demonstrated ability leading a complex team and influencing colleagues

Head of Clinical Operations, Sequencing Resume Examples & Samples

Responsible for the execution of all clinical trials (registration, pre-registration and post-registration) in support of company products for the LifeCycle teams. Through direct reports, oversees the planning, and execution of the business area’s clinical trial program that will support preliminary data for FDA registration trials, FDA registration trials to support clinical claims as well as claim expansion of products for the Company. Lead additional post-marketing clinical trials of CE-marked and FDA registered products
Directs the Clinical Operations Team Leaders for each LCT to implement the clinical plan for the LCT for FDA registration trials; this will include generating scientific data to support claims for Roche Sequencing products. Ensures flexible personnel management of Clinical Research Associates to support effective implementation of clinical trials designed by Clinical Research Team for each Life Cycle and Business team (Clinical Research Team consists of Clinical Research Director, Clinical Ops Team leader, Scientific Affairs Director). Supervises Director of Clinical Operations for Sample procurement to obtain samples for LCTs, banking of specimens for Clinical Trials for Roche Sequencing
Responsible for execution of clinical trials that includes FDA PMAs, 510ks, CE marked studies; Other trials include those required to generate preliminary data leading to design of effective FDA trials; post-approval product comparison trials; post-approval clinical utility and claim expansion trials
Deals with broad, new issues with limited guidance or direction. Develops solutions based on limited information and input from only the highest levels of the organization
Primary spokesperson for own area(s) on highly significant matters. Negotiates complete agreements that significantly affect key customers or major internal projects
Leads the implementation of global study support strategies and initiatives
Recognized as a senior authority within the organization and a leader in the profession
Develops leaders throughout the organization and assures the development of all individuals within the organization
Develops and is accountable for budget of area(s)

Director, Early Clinical Operations Resume Examples & Samples

Collaborates with Regional Heads of Development Operations to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of clinical trials in support of IGDP and studies in assigned TA
Ensures clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP
Responsible for global budget planning/forecasting and management for assigned therapeutic area. Financial oversight responsibility ranges from $80-$400MM
Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling
Maintains current therapeutic area knowledge and continually assesses impact of new and evolving information on operational strategies
Supports Global Development Strategic Outsourcing by leading portfolio level planning and Early Engagement process with strategic vendors in assigned therapeutic area, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of performance issues
Responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment
Acts as a role model for Takeda´s values
At least 10 years clinical study/program management experience in the pharmaceutical industry, including at least 5 years of line management experience. Experience in more than one therapeutic area highly desired
Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP
Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written)

Clinical Operations & President Resume Examples & Samples

Progressive and successful healthcare industry experience, specifically in the Integrated Hospital System/Care Delivery, Hospital, or Clinic space
Strong relationship building skills and broad knowledge of Medicare products strongly preferred
Excellent analytical, problem solving, presentation, collaboration, negotiation, and oral and written communication skills required
Bachelor's degree or equivalent experience required, MBA preferred
Special consideration to physician executives with operations experience

Clinical Operations Program Manager Resume Examples & Samples

Matrix leader of cross-functional global Clinical Program Team responsible for operational strategy for assigned clinical program; serves as main point of contact for regional, global or cross functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues
Provide program-level direction to clinical study manager(s) for the development of study management plans including enrollment models and , risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; collaborates with Associate Director, Clinical Operations to ensure inspection readiness
Support functional strategic initiatives and processes managed by Clinical Services Group

Clinical Operations Director Resume Examples & Samples

Work with the Clinical Operations teams to make sure project/program/portfolio budget(s) meet financial and corporate expectations
Work with staff to make sure all study management and project/program/portfolio deliverables are completed per Contract, to achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices. As their point of contact, provide effective and timely consultation/guidance to Clinical Operations leaders and staff on issue resolution
May serve as a back-up on projects, programs and portfolios as needed
Will work cross functionally and serve as a Clinical Operations liaison with other groups within Array in order to remove barriers and seek efficiencies in the delivery of clinical trials and corporate goals
Help Department Head to Optimize and implement SOPs, processes, communication, & infrastructure within Clinical Operations to support company goals including Regulatory filings
Collaborate with the development project teams to ensure integration of the operational strategy into product strategy
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
Obtain regular feedback on employees from other clinical project team members and key stakeholders to facilitate ongoing performance management and development. May attend project team meetings to provide direct observational feedback. Define appropriate goals & objectives for individuals and team. Identify skill and competency gaps at the individual level and work to craft and support appropriate development plans
Collaborate with other management and leadership colleagues/peers to proactively identify resourcing solutions and project and/or individual needs in order to manage studies/programs
Manage and mitigate risks linked to resourcing and project and/or individual needs proactively with other management and leadership team members in order to manage study issues and obstacles
Work with individual staff to identify any quality issues within the program/portfolio and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation
Direct, manage and mentor an assigned team of Clinical Operations staff who lead and/or manage those who lead studies or programs. Actively provide guidance/coaching to achieve global alignment of work practices across the team
Responsible for sponsoring /championing multiple operational excellence teams to drive best practice across Clinical Operations and Development within a matrix organization
Ultimately accountable for helping to meet business goals and assigned corporate goals
Has line management responsibility of Director level staff and below
Willing and able to travel domestically and internationally as required, approximately 30%
BS/BA in life sciences or related field
15 years clinical research experience including 10 years leadership experience (managing people), in multiple therapeutic areas with a heavy focus in Oncology
In-depth experience working on clinical trials with established experience in a leadership capacity across a portfolio of work; or equivalent combination of education, training and experience
Experience of both early and late phase development
Significant leadership and management experience in the biotechnology or pharmaceutical industry
In depth knowledge in GCP/ICH and applicable regulatory guidelines. Knowledge of clinical research financial parameters and project financial tracking and accounting methods
Strong leadership and presentations skills. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Strong written and verbal communication skills in local language including a good command of English

VP, Medicaid Clinical Operations Resume Examples & Samples

Responsible for the development of business plans and budget, recommending changes and enhancements to services and benefits, and implementing management processes according to organization and department policies and procedures
Assists in the coordination of network management activities, achieving of organizational goals and objectives and overall medical/loss ratio, and the enhancements to management information systems
Support and participate in physician, hospital, and ancillary provider education
Responsible for compliance with all regulatory and accreditation standards
Bachelor’s degree highly preferred
Active Registered Nurse (RN) or clinical license preferred
At least ten years’ experience in care coordination / quality management
Five years progressive experience in clinical management
Knowledge of health plan NCQA accreditation, regulatory standards, regulatory reviews, and HEDIS

Senior Consultant, Clinical Operations Resume Examples & Samples

Achieve and maintain advanced knowledge of Cardinal Health's NPWT devices/component operation and use
Provide Phone, email, and in-person training and clinical support to clinicians and ITI employees/distributors
Provide initial and ongoing clinical training for sales and FSR team members
Present clinical information during sales presentations
Coordinate clinical aspects of product evaluations and conversions
Assist with trade shows and other marketing functions
Develop presentations and educational tools
Review and assist in the development of marketing tools
Assist with field testing of new products
Assist with gathering clinical information related to complaint investigations
Assist with other products and projects as needed
Undergrad required
6-8 years of experience in related field
Wound Care Certification preferred
4-6 years of clinical experience in wound care, including NPWT
Ability to travel 80%
Must provide proof of, and maintain current immunizations and obtain additional immunizations appropriate for the facility which enables access to customer sites in order to perform essential job functions. Proofs must include: Hepatitis B, Influenza (current year), MMR (mumps, measles, rubella), Varicella (chicken pox) Annual TB/PPD (skin test), Tetanus/Diphteria/Pertussis
Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
Projects may have significant and long-term impact
Provides solutions which may set precedent

Supervisor, Clinical Operations Resume Examples & Samples

Ensure that the staff under his/her supervision area at all times adequate in quality and quantity to meet the agreed forecasted workload. Recommend changes if necessary and justify them in accordance with company policy
Plan and schedule training inservices for his/her staff
Respond constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action
Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff
Ensures that up to date manuals of SOPs and Policy and Procedures are available to all personnel in his/her work area
Performs Project Management duties/responsibilities in the absence of team Study/Project Manager
Acts as Study Manager for straightforward/uncomplicated Phase I protocols, under supervision of a designated supervisor
Schedules investigators for protocol-related tasks
Tracks and evaluates Interdepartmental Monthly Key Result Indicators
Works on a wide range of opportunities and problems where use of creative thinking and the application of related quality and continuous improvement theories and principles is required
3-4 years research experience
Minimum of 2 years supervisory experience

Director of Clinical Operations Resume Examples & Samples

Director of Nursing Services experience preferred (3 years) – other experience considered
Multi location oversight responsibilities preferred
Thorough knowledge and understanding of long-term care State and Federal regulatory processes
Ability to communicate all levels of the organization, and work well within a team environment
Ability to analyze data and create effective performance plans
Excellent communications, presentation, analytical, and problem-solving skills

Coagulation Clinical Operations Study Manager Resume Examples & Samples

Be a member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Medical Affairs, Regulatory Affairs and Biometrics in the study overall design, validation and planning. Responsible for risk mitigation strategies, associated action plan and issue resolution
Provide Coagulation technical expertise
Have responsibility for timelines, resource allocation and budget planning
Provide oversight to outside support including CROs, consultants and/or medical advisors

Manager Medical Clinical Operations Resume Examples & Samples

** This position requires travel in the state of Michigan****
Manages and is accountable for clinical and non - clinical professional employees and/or supervisors
Reviews operational and performance metrics regularly and partners with direct supervisor in driving action plan development and execution
Current, unrestricted RN license in the State of Michigan and / or LCSW,LMFT, LMHC
3+ years of hands - on clinical experience
2+ years of Supervisory or Management experience (including performance management functions i.e. hiring, performance evaluations, corrective action plans etc.)
Reliable transportation to travel to member homes or other locations within the service delivery area, as needed to support field audits and meetings
Problem solving skills, detail oriented and highly organized
Strong Data Analytic Skills
Certification in Case Management (CCM)
Managed Care / Insurance experience
Experience managing a virtual and / or field - based team

Regional Director of Clinical Operations Resume Examples & Samples

Nurse Licensure Compact (NLC) documents the following: The mutual recognition model of nurse licensure allows a nurse to have one license (in his or her state of residency) and to practice in other states (both physical and electronic), subject to each state’s practice law and regulation. Nurses must legally reside in a NLC state to be eligible to have a multi-state license
Detail oriented; self starter; requires minimal supervision
Dependable transportation, valid driver’s license and automobile insurance coverage
Must be familiar with general use and functions of the computer, such as, user names and password concepts; internet e-mail; navigation of computer desktop; including starting programs, using files, and windows, effectively use navigation buttons and tool bars; ability to self-manage online HR services and online training programs

Supervisor of Clinical Operations Resume Examples & Samples

Recruit, hire, train and supervise assigned employees
Ensures that office space, supplies, equipment, and assistance are provided and maintained appropriately
Responsible to ensure accurate charges are entered in IDX
Actively participates in financial reports, budget and prepares variance reports
Attends required meetings and participates in committees as requested
Responsible for implementation of safety functions in clinics and daily facility management to include alarm response (if applicable) and facility maintenance. Attend safety meetings and provide input for change to meet safety regulations. Ensure completion of safety training for new employees and completion of quarterly fire drills
Collaborates with Physician Leads in the performance evaluation process
2+ years of administrative customer service experience (preferably in a healthcare environment)
Strong computer proficiency with Microsoft Office i.e. Word, Excel, and Outlook
2 - 5 years of Management or Supervisory experience in a clinical setting
Electronic Medical Records (EMR) experience preferred
Prior experience in payroll a plus

Team Lead, Clinical Operations Resume Examples & Samples

Key contributor to core study documents including the protocol, ICFs, and DSMPs
Development and maintenance of all study operational manuals, sponsor forms/templates
Submission/management of Coordinating Center Submissions through University of Pennsylvania regulatory review committees for applicable trials
Development of clear and measurable project management plans
Coordination of all site start-up activities- including qualification of participating sites, site initiation visit, site training, etc
Facilitation of case report form development, review, approval, and finalization with the Data Management Team; ensure development of ongoing database modifications as needed
Development and maintenance of CRF Completion Guidelines to guide site data entry, monitoring and data cleaning activity
Monitoring of ongoing project status and timelines, and associated deliverables; provide regular updates to the sponsor team, collaborators, and senior leadership
Oversee site management on behalf of the sponsor team; Track/manage enrollment slots across multisite trials
Organize and coordinate DSMB Meetings; Prepare and process DSMB Reports
Review/process protocol exceptions/deviations
Coordinate/lead regular Sponsor Team and Sponsor-Site Team meetings
Develop and provide study and/or protocol amendment training to sites
Manage/maintain the Sponsor Trial Master Files for each project/site
Routine reporting of study progress and subject statuses; provide IND summary information for the IND annual report or in response to FDA requests

Supervisor Clinical Operations Southwest Medical Resume Examples & Samples

Supervising and coordinating staff and clinic activities to provide quality, cost - effective care
Provides technical and business support to Imaging department, APCC Imaging Lead, assigned staff and supervision of daily clinic operations
Requires independent judgment to identify, initiate and assess corrective action for known and potential problems
Addresses and resolves workflow issues and patient complaints
Responsible for Imaging referrals, expedited reports, oversees File Room processes and protocols including imaging result notification and importing / loan outs for imaging studies
Prepares reports and manages assigned projects, oversees all business related functions including cash handling and daily batch audits
High School diploma and / or equivalent
Knowledge of organization policies and procedures
Computer application skills, including strong Microsoft Word and Excel
Possess fiscal management and human resource management techniques and practices
Understanding of process flows regarding service levels, cash handling and collections
Strong knowledge of Medical Terminology, ICD-10 and CPT coding
Excellent leadership skills to include strong communication (written and verbal) and interpersonal skills
Ability to gather, analyze and evaluate data
Able to use Radiology computerized management system, PACS, Electronic Health Record and all other applicable facility computerized systems

Head of Clinical Operations Resume Examples & Samples

Fluent in English and Mandarin (both verbal and written) required
Bachelor Degree in Clinical Medicine, Pharmacy or Life/Biological Sciences
15 or more years experience in Pharma Industry and at least 10 yrs in managerial position
At least 12 yrs Clinical Research Experiences on managing global and local clinical trials
Responsible for ensuring the end to end delivery of pre- and post approval clinical programs in compliance with GCP, regulations and SOPs, and generating scientific data to achieve regulatory submission for All TAs
Create effective clinical operational process and implement strategies to manage risks on clinical program timelines, budgets and goals, share and drive best practice with team members and apply same process and standards among the teams across different TAs
Positively interfaces with and influences across a diverse and scientifically advanced population including external experts, regulators and investigators in order to deliver clinical trials and meet business needs
Oversee and evaluate the appropriate CROs to provide clinical services in compliance with the appropriate GSK policies and procedures
Actively contributes to overall China Medical development and therapeutic area specific strategy for all TAs
Being a visible leader to build strong connection with global clinical development like PCPS, GDS and CDQA, as well as Regulatory and cross functions in China, incorporate global considerations into strategic and operational decisions
Establish and maintain high performing, motivated and productive core clinical development team of study management and site management by setting appropriate and effective process and KPIs and promoting people development
Line Manager of Study Management Leaders, CRA Managers and Clinical Trial Admin Manager with a clinical development budget of ~5-7 M GBP for China-specific studies, as well as managing globally funded studies
Primarily accountable for ensuring that all clinical operational processes developed within China Medical are appropriately designed and deployed with the goal of ensuring quality and timeline according to overall China Medical strategies
Primarily accountable for and contributes to clinical project delivery in planning, implementation and close-up with special attention to quality, timeline and costs for china-specific studies as well as global studies
Accountable for influencing and collaborating with many internal HQ counterparts and cross departments to ensure sufficient support is obtained in design and approval of clinical research protocols, preparation and delivery of clinical supplies, data collection, and monitoring
Accountable for developing and implementing plans for study delivery, and developing contingency plan to identify and carry out risk management activities
Accountable for overseeing the selection of CRO providers, selecting the vendors and managing the relationships with vendors via procurement and contract teams
Serves as a clinical point of contact for senior management and senior level matrix teams, both internally and externally

Manager, Global Clinical Operations Resume Examples & Samples

Recruitment, hiring, training and development of direct reports
Oversee project assignment, workload distribution and problem resolution with direct reports and, as needed, team management and other functions
Identify, train and provide oversight of consultants
Performance and development in accordance with Performance Management guidelines, including coaching, mentoring and routine feedback
Evaluate and project resource needs on an on-going basis. Ensure the implementation of clinical studies through efficient allocation of LTMs, SMs and Administrative Associates
Ensure close working relationship between other GCO US groups and internal/external business partners
Participate in business-related task forces to improve processes
Understanding GCO Standard Operating Procedures (SOPs) and fulfilling the responsibilities per those SOPs
Ensure adequate, timely and compliant monitoring and management of clinical studies conducted in assigned Therapeutic Areas
Ensure that team meets project deliverables according to timelines, within budget, and with quality
Communicate with staff on program changes, policy changes, and priority shifts on a regular basis
Awareness of issues affecting staff's workload and efficiency
Ensure staff fulfills roles and responsibilities appropriately and in a timely manner
Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies
Participate in Management Staff meetings. Conduct staff meetings
A minimum of 8 years of Clinical Research experience within the Pharmaceutical, Clinical Research Organization (CRO) and/or Biotech industries is required
Knowledge of Neuroscience and/or Immunology Therapeutic Areas preferred
Experience with the direct management of employees is preferred
Experience managing and executing clinical trials preferred
Knowledge of FDA regulations as it pertains to Good Clinical Practices (GCPs) preferred
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
The ability to collaborate with all levels of management in a matrix environment is required
This position will require up to 25 % domestic travel, primarily for meetings and accompanied site visits.Clinical Trial Administration

Senior Consultant, Clinical Operations Resume Examples & Samples

Facilitate acquisition of new business through product evaluations and implementations
Drive clinical cost saving measures through Measure and Adapt process
Participate in the education of the sales force
Support product marketing initiatives
Actively support Strategic Account Executives and Full-Bag Product Sales reps by getting ‘pulled in’ as required to provide assistance in clinical product sales
Articulate product value proposition to clinical customers (e.g., physicians) and provide detailed description of attributes – be the ‘go to’ resource for a specific product
Provide peer to peer product expertise and clinical expertise in the OR and other clinical areas
Demonstrate features and benefits of products through hospital trials
Provides field based clinical education to product sales force and work closely with RD to clinically position products into administrative levels of the hospital
Registered Nurse with current RN licensure preferred
Ability to travel and cover the Central region (MT, ID, WY, UT, CO, NE, KS, OK, TX)

RRT Clinical Operations Coordinator Resume Examples & Samples

Three or more years as a Respiratory Educator or extended history of initiative in education programs/projects
Minimum five years experience in Respiratory - one to two years supervisory or preceptor experience preferred
NICU experience is preferred

100

Associate Clinical Operations Specialist Resume Examples & Samples

Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: Update data, timelines, milestones, EC/HA authorizations, etc. for Countries and Sites on an ongoing basis
Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF)
Experience of clinical study coordination in a pharmaceutical company or contract research organization

101

Director of Clinical Operations Resume Examples & Samples

5+ years of Regional, Divisional or Corporate experience in Senior Living; 3+ years of experience in a Skilled / Post-Acute setting
Expert knowledge of current State and Federal government Post-Acute Care regulations
Strong assessment, clinical, and documentation skills
Solid analytical and critical thinking skills
Electronic Health Record experience
Proficiency in QAPI systems

102

Clinical Operations Performance Improvement Senior Manager Resume Examples & Samples

Provides solutions to complex business problems for area(s) of responsibility where analysis of situations requires an in depth knowledge of organizational objectives
Involved in setting strategic direction to establish near term goals for area of responsibility
Interacts with senior management levels at a client and/or within Accenture, which involves negotiating or influencing on significant matters
Has latitude in decision-making and determining objectives and approaches to critical assignments
Decisions have a lasting impact on area of responsibility with the potential to impact outside area of responsibility
Manages large teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Leading and delivering transformational initiatives across complex, large-scale health care Payers or Providers and for contributing to the design and implementation of solution offerings
Identifying and prioritizing client value creation opportunities while integrating an understanding of client visions, performance gaps, and needs
Planning and implementing the recommended changes to organization, governance, operations or project/initiatives
Designing and developing business processes to ensure the achievement and sustainability of improved outcomes
Shaping and leading the business solution implementation: defining and supervising business architecture, process design and development activities, developing capabilities and performance measurements/KPI's
Implementing plans and leading teams to execute project deliverables on target, on time and on budget
Assessing and managing risk throughout the project lifecycle and making adjustments as needed to ensure planned business outcomes are achieved
Designing the projects overall communication strategy and approach for the targeted change journey
Managing full scope of Accenture team and associated contract delivery
Managing project financial's
Looking for candidates residing in all regions or candidates open to relocation into the following regions: Southeast, Midwest, West, and Northeast
Minimum of 8 years of Healthcare Industry experience
Minimum of 5 years of Provider experience, specifically within Performance Improvement working with clinicians
Minimum of 3 years of external consulting experience
Minimum of 5 years of Project Management experience, leading large teams, large scale projects
Master’s Degree in healthcare or business related field
Business Development experience
Strong analytics skills
Coaching experience, supervising, training and mentoring others
Proficiency in Microsoft PowerPoint, Excel and Word
Desire to work in an information systems environment
Excellent ability to develop client and internal relationships

103

VP of Clinical Operations Resume Examples & Samples

Responsible for all direction of Connections and Crisis Intervention departments
Oversees the functioning of all hospital intake, discharges and transfers and bed flow
Oversees the utilization review functions for the hospital
Oversees the Mental Illness Court functions
Develops and maintains policies and procedures for areas of responsibility
Monitors and evaluates quality and appropriateness of social service interventions and programming
Serves as a liaison between physicians, Licensed Independent Practitioners, patient care vendors, and the hospital
Manages area in a prudent fiscal manner; maintains productivity and targets as appropriate
Works with and supports the CEO, CNO, COO and CFO on hospital operations
Conduct reinforces the Company’s values and promote the Code of Conduct
Meets his or her leadership obligations under the Ethics and Compliance Program
Proficient in basic computer application skills, data entry and system process flows
Master’s degree in Social Work or a Healthcare related field
5 years of management/supervisor healthcare administration experience
Prefer LMSW /LCSW

104

VP of Clinical Operations Resume Examples & Samples

7+ years of related experience
Knowledge of ASC regulation and Joint Commission
Working knowledge of OmniForm
Microsoft Office/Suite proficient (Access; Excel; Outlook; PowerPoint; Publisher; SQL Server; Visio; Word)

105

Clinical Operations Director Resume Examples & Samples

5 years of nursing experience with at least 2 of the years of nursing experience must be in a management role
Skills: Change management; able to develop leaders; able to develop new teams (strong coach); and serve the team and patient population
Current registration with North Carolina State Board of Nursing as a registered professional nurse OR current compact RN licensure to practice in the state of North Carolina required
Professional specialty certification (preferred)

106

VP Clinical Operations Resume Examples & Samples

Takes full ownership and accountability for all accounts for clinical outcomes including operational delivery, programs requirements, improvement to existing processes and leadership of managerial teams
Develops clinical management teams instilling an engaged employee culture that delivers exceptional outcomes to our customers to support Specialty’s goals of business retention and product expansion with existing accounts
Support opportunities for new client sales by participating in sales or client meetings as well as developing a strong clinical story that positions NIA as a leader operationally and clinically in all clinical products and other activities as needed

107

Lead Rehab Clinical Operations Resume Examples & Samples

Assists Leaders in managing staff including recruiting, hiring, orientation, training, coaching, professional growth, development plan, performance improvement, and performance appraisal
Assists Leaders in planning, organizing & overseeing daily clinical operations. Adjusts staffing plan to meet department needs and identifies improvement opportunities for operational efficiency
Assists Leaders in guiding teams in evidence-based practice initiatives including implementing clinical practice guidelines and protocols. Coordinates annual clinical competency process
Prioritization criteria, waiting lists, scheduling queues, and patient transfers from one location to another. Facilitates transition from inpatient to outpatient
Responsible for resolving patient complaints or related issues. Follows up as needed with key stakeholders for conflict resolution and service recovery
Leads in program development or expansion as a clinical SME aligned to strategic or operational goals. Provides guidance on programmatic issues related to therapy services & programs
Assists Leaders in establishment of service line & departmental standards, monitors metrics, provides training, and ensures compliance of hospital customer services program
Responsible for the performance improvement process including the preparation, analysis & submission of required reports. Prepares monthly financial variance reports & productivity analysis
Evaluates, re-evaluates, and performs general and specialty evaluations according to departmental standards. Administers formal tests and documents results
Completes a treatment plan of care with appropriate functional, realistic, and measurable treatment goals. Incorporates parent education into the plan of care and treatment
Implements patient treatment based upon medical, clinical, functional, and observational findings. Revises plan of care as necessary
Mentors and serves as a resource to clinical staff in the provision of direct patient care
Initiates discharge planning considering medical, social, financial, and personal issues of the patient/family. Prepares discharge when maximum potential or benefit of therapy is reached
Maintains active and supportive communication with the patient, caregiver(s), and others concerned regarding progress, problems, home programs, and other issues related to the therapeutic process
Maintains & documents productivity standards set by the Leader. Maintains clinically productive time in direct patient care between 15%-50% of work hours/week based on center staffing needs
Records daily patient documentation, statistics, and charges accurately and in a timely manner as determined by meeting departmental standards
Master or Doctoral degree preferred
1 year of experience in a supervisory and/or administrative capacity in rehabilitation preferred
Ability to objectively supervise a diverse multidisciplinary departments
Ability to learn appropriate software applications including MS Office
Leadership and good supervisory skills
Knowledge in data collection and interpretation

108

Manager Regional Clinical Operations, Downey Resume Examples & Samples

Works closely with the Compliance staff to ensure that the CCCs meet or exceed regulatory compliance with OSHA, DHHS, CMS, State, and health plan regulations
Informs the Risk Management staff and DCO of any potential risk management issues in the CCC
Evaluates and implements vendor contracts and services for CCCs
Perform other duties upon supervisor’s request

109

Manager of Clinical Operations Resume Examples & Samples

Provides clinical support to RN’s and LPN’s in the Wound Management Program
Utilizes communication tools to ensure staff members receive information (e-mails, memos, flyers, etc.)
Collaborates with new staff members to plan an individual orientation to the department
Functions as a resource and facilitator to staff during crisis or emergency situations
Promotes an environment of collaboration with medical staff and hospital departments to provide for the needs of the wound management patients
Maintains overall accountability/responsibility for staffing the Wound Management department during all hours of operation
Develops and follows staffing guidelines for the Wound Management program considering identified patient population, skill type and level of personnel and budgeted man-hours per unit of service
Monitors productivity and provides explanation for variance as requested
Identifies and communicates to the CNO modifications of staffing patterns needed to meet patient acuity, technology and resource management within secretarial staff and Wound Management Program
Defines in writing the scope of service for responsible departments
Demonstrates continuous competency with the e-MAR medication process to include patient & medication scanning
Works collaboratively with all disciplines in the development of policies and procedures
Encourages staff to participate in hospital and/or nursing committees, task forces, issue/action groups
Current Florida RN license
Active Florida Driver’s License
Current American Heart Association Healthcare Provider BLS (Must be retrained within two years of the month end course date)
Must obtain ACLS within one year from date of hire (Must be retrained within two years of the course anniversary date)
Clinical Competency (evidence based) by completion of unit specific skills checklist (Must complete annually)
Training/Education required for position annually

110

Clinical Operations Analyst Resume Examples & Samples

Masters in Health or Business Administration preferred
Minimum of three years’ experience with process improvement and data analysis
Extensive experience with a wide range of professional report preparation
Experience in health care environment, preferred
Epic Ambulatory experience, preferred
Working knowledge of regulatory standards( State laws, CLIA, OSHA, HIPAA, DHEC), preferred

111

Clinical Operations Lead Resume Examples & Samples

Clinical Scientist for Phase I/II studies including multi-country / multi-center trials
Clinical Project Manager for outsourced profiling studies responsibilities include
Act as the internal point of contact for vendor(s) conducting outsourced studies
Oversee outsourced activities, involving key stakeholders to ensure integration and alignment with study objectives
Measure the effectiveness of the vendors in meeting timelines and deliverables and ensure alignment of vendor activities to priorities and strategy
Eliminate duplication of efforts between vendor and internal team
Improve working relationship with vendors (e.g. communication, collaboration, issue resolution) and drive continuous improvements to the outsource model
Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised
In collaboration with the Medical Expert and CTT, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner
Responsible for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers
Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear delegation /assignment of duties are documented
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists
Good knowledge of Good Clinical Practice
Used to working independently and in a team environment, being flexible and adapting in a changing environment

112

Hospice Regional Director of Clinical Operations Resume Examples & Samples

Current and unencumbered license to practice as a Registered Nurse specific to that state the employee is assigned to work by the company with at least one (1) year supervisory or administrative experience in home health care, hospice care, or related health programs
Minimum of two (2) years of home health experience
Demonstrates knowledge of Federal, state, local and ACHC regulations
Demonstrated knowledge of the appropriate skills for communicating at all levels within the organization

113

Regional Director of Clinical Operations Resume Examples & Samples

Current R.N. licensure in State of operation
Excellent organizational skills, with the ability to prioritize and manage multiple projects simultaneously
Proficient Microsoft Office Suite skills
Proven self-starter who sets aggressive goals and consistently delivers results

114

Global Head MSA Clinical Operations CPS Resume Examples & Samples

Lead, shape and drive the clinical operations department consisting of the areas Study Management, Study Monitoring and Services & Systems (incl. Sample Management)
Lead Clinical Operations staff responsible for design, execution and reporting of all clinical studies for regulatory submissions in support of launch claims and post-launch claims
Plan and manage timeline and resources for all study related activities across different therapeutic areas, our Roche instruments and post launch activities
Ensure close collaboration with other business areas and functional areas, like Tissue Diagnostics, Sequencing, Quality, Regulatory
Drive the CPS organization and strategy toward clinically differentiated diagnostics solutions as part of our Medical Value strategy and support of cross-Business Area and cross-Divisional projects in support of Roche’s Personalized Healthcare strategy
Talent management and organizational change to support Roche's long-term success
Anticipate and influence emerging (global) trends in Evidence-Based Laboratory Medicine
Participate in the business and strategy setting, in particular by being a key member of leadership committees and ensure governance, compliance and drive risk management

115

Director of Clinical Operations Resume Examples & Samples

Coordinates/integrates department services with the hospital’s mission vision, values and Five Indicators of Success
Exercises independent judgment within the context of interdisciplinary patient care
Delegates tasks appropriate to meet the needs of the individual patient and to the skills of the employee supervised
Plans, implements, revises and delegates nursing care with patient safety as the primary goal
Determines the qualifications/competence of personnel
Maintains/implements quality control programs
Identifies and selects outside sources for needed services
Participates in development and evaluation of professional practice by participating on unit and/or hospital committees, special projects and attendance at staff meetings and town halls
Delivers patient care and/or department service in a safe, competent, and efficient manner as determined by outcomes, quality monitors, and other internal and external processes
Maintains positive interpersonal relationships and self conduct to contribute positively to the delivery of quality care and services, and to orderly operation of the department and the facility
Maintains and enhances skills through consultation with interdisciplinary team members, participation in planning activities, and attendance at in-service and continuing education programs
Follows established guidelines for compliance with Infection Prevention and TJC Patient Safety Goals and Practices
Uses Performance Improvement process to improve patient safety and patient outcomes

116

Clinical Operations Coordinator Resume Examples & Samples

Provides administrative support to the Clinical Operations department including: process system generated correspondence, research incorrect/missing demographic information, and create and file documents in the medical record
Perform system generated tasks efficiently and accurately utilizing word processing software
Pick up and distribute materials for Clinical Operations staff

117

Clinical Operations Specialist Resume Examples & Samples

Provide technical support by tracking and reporting trial budgets, invoices, and related financial documentation (e.g. purchase orders) with a significant portion of the responsibilities focused on review, approval and tracking of invoices for the department
May be asked to interact with vendors to reconcile any invoice discrepancy
Organize and maintain both paper and electronic Trial Master Files (eTMF) and provide eTMF administrative support activities
Provide technical support as needed, by tracking ancillary clinical supplies and other trial-related documents and materials
Create and maintain vendor contact lists as well as other internal lists
Perform and/or maintain data entry in internal systems (e.g. Veeva Vault)
May be asked to assist in communication with external vendors, in support of operational activities
Assist in the preparation of trial updates and presentations (e.g, Excel, MSProject, Powerpoint)
Assist with internal meetings by distributing agenda and recording and distributing minutes
Coordinate and provide technical oversight for both internal/external meetings (e.g. WebEx)

118

Supervisor Clinical Operations Resume Examples & Samples

Demonstrates effective leadership and management skills
Demonstrates effective interpersonal and communication skills
Evaluates staff performance, reviews evaluation results with each employee and updates profile accordingly
Plans, develops and promotes the necessary facilities, equipment, supplies, and record system to assure competent delivery of occupational health services
Assists with the planning, development, and design of satellite clinics
Determines equipment needs within budgetary limits
Analyzes, plans, and assists the staff in the development of the medical component of the OHM/MIMS system (i.e., daily clinic visit data, accident investigation report, computerized (OSHA logs)
Maintains confidentiality of all medical records in accordance with good medical practice, Abbott policies; federal, state and local government requirements
Collaborates to create and maintain and reconcile the Occupational Health Services budget
Analyzes cost of providing services, develops and implements strategies to enhance cost effective services
Ensures operation of Occupational Health Services are within budgetary requirements
Determines fiscal priorities
Determines need for vendor and contractor services for medical services, equipment and supplies
Collaborates to develop and implement budget for merit raises
Assumes responsibility for adequate data collection to determine staffing and program needs
Determines staffing needs and overtime requirements
Elicits customer input to promote quality service
Facilitates the use of the Electronic Healthcare record tracking of OSHA mandated programs for compliance
Determines operational requirements for provision of occupational health services: staffing coverage, Hours of operation, Flexible schedules to cover various shifts, Special programs requirements, Scheduling of employee appointment
Procures necessary supplies and equipment
Participates in staff selection and determines the qualifications and functions of various positions
Develops, reviews and updates job descriptions
Reviews candidate applications and selects applicants for interview
This position is responsible for
Facilitation of new staff training and orientation
Administration of schedules
Involvement of staff in relevant committees (Division responsibility for OSHA log, Safety committees, QA audit committee)
Investigates, documents and resolves complaints or incidents concerning employees, visitors, physicians and staff
Participates in development and attainment of divisional and site goals
Makes presentations to divisional management, representative of Human Resources, Employee Relations and Safety based on their individual needs
Provides leadership, direction and technical counsel to members of the Occupational Health team (i.e. safety, industrial hygiene, bio-safety)
Prepares quarterly report to management showing services delivered by each site clinic
Works to reduce medical cost by promoting optimum levels of health, which reduces absenteeism, re-injuries and disease
Participates in cross-divisional teams and tasks forces to ensure employee safety and to develop and administer injury/illness and disability management controls
Collaborates on related matters such as safety programs, industrial hygiene and health promotions programs
3-5 financial/statistics
Knowledge of worker’s compensation
Occupational health and safety
1-3 years supervisory experience

119

Clinical Operations Intern Resume Examples & Samples

Meeting scheduling and logistics (including food & beverage coordination, call/web conference activation, resolution of technical issues, distribution of agendas and generation of meeting minutes)
Document tracking and signature/approval follow-up (including Confidential Disclosure Agreements (CDAs), contracts, protocols, and other documents required in the study file)
Creating and maintaining study/project contact lists and tracking tools for budget, enrollment, samples, site supplies, and other study-specific needs
Maintaining study timelines
Microsoft Office support for study and department documents
Other tasks/project support as assigned
Perform all responsibilities in accordance with applicable Standard Operating Procedures, guidelines and work instructions
Pursuing a BS in an applicable field with a specific interest in health care, genomics, clinical trial management and/or diagnostics
Demonstrated competence with Microsoft Office (Word, Excel, and PowerPoint)
Well organized and detail-oriented
Comfortable in a fast-paced, rapid growth environment
Strong oral and written communicator with ability to maintain open communication with internal employees, managers and customers as needed
Able to work as part of a team
Knowledge of Good Clinical Practice (GCP) and ICH guidelines

120

Clinical Operations Director Resume Examples & Samples

Provide creative and thoughtful leadership in the integration and alignment of LivingWell goals with internal and external business partners. Nimble thinker, able to understand the needs of markets, and steer the organization to adapt accordingly
Collaborate with peers especially LivingWell Senior Medical Director and Pharmacy Leader to develop and implement strategy, business plans, and operating systems, consistent with the broader strategy, plans and goals of the organization
Provides thought leadership and drives organization to achieve “triple aim”: improves the individual experience of care, improves quality and the health of Cigna HealthSpring’s population, and reduces the per capita cost of care and improves the quality of care metrics for the population
Ensures a strong “customer centricity” focus throughout LivingWell operations, with a monitoring component to provide feedback for leadership review and for staff. Further, ensures processes are in place to response to patient complaints and resolve problems leading to the complaints
Operationalizes new business opportunities that contribute to growth and market positioning of LivingWell
In a coordinated approach with medical leadership, develops and implements procedures, policies and means of accountability that result in complete continuity of patient care – from inpatient to clinic, rehabilitation, home care, skilled nursing facilities, and any emerging additional features of the wellness and healthcare continuum
Positions LivingWell to adjust to healthcare reform changes associated with quality, billing, market pressures, and policies
Assures consistency of operations, compliance with all applicable laws, rules and standards of all regulatory bodies and accreditation agencies
Leads programs that improve value streams by improving processes toward effective operations and efficiencies, patient experience and physician-client satisfaction, while increasing revenues and reducing costs, thereby enhancing competitive position of LivingWell and the communities they serve
Leads real estate planning, capital allocation and facility development, in collaboration with Cigna real estate and other matrix partners. Oversees new clinic & embedded locations and remodeling of current locations
Develops people and systems to provide a talented, customer focused and highly engaged staff committed to Cigna, Cigna-HealthSpring, and LivingWell’s vision and values
Fairly and accurately assesses talent. Coaches and develops leadership talent ensuring that short and long range succession plans can be met. Ensures a consistent pipeline exists for critical and multi-incumbent leadership positions
In close collaboration with medical leadership, routinely performs staffing model and workforce analysis to reassess needs of the clinic and business operating units assuring effective utilization of human capital. Forecasts staffing needs and makes appropriate adjustments to maximize use of human resources, making decisions based on the needs of customers (patients)
Ensure all elements of the strategic plan are implemented within the Health Care Centers, Strategic Business Units and departmental operations. Ensures the direction of the Strategic Business Units, departments and HealthCare Centers are in alignment with the organization’s strategic goals. Verify all initiatives for change meet the strategic filter criteria ensuring alignment with strategic direction
Responsible for developing and maintaining a business/management approach to track, monitor, communicate and achieve established goals/targets in the areas of: (a) employee satisfaction, (b) customer satisfaction, (c) quality, (d) compliance, and (e) financial results
Provide effective leadership for all staff by establishing open communications, mentoring, and training guidance
Meet or exceed all State, Federal and regulatory requirements
Ensure safe work environments by assisting with physical planning and monitoring of new and existing structures
Support the Center Administrator’s relationship with the medical administrative team as it pertains to Center Administrators’ direct involvement with provider management
Perform at or below target for voluntary attrition of all staff
Minimum of a Bachelor’s degree in a Business, Finance, Health Care Administration or related discipline; MBA, MPH, MHA preferred
Seven to ten years leadership experience, preferably within a large clinical organization with multi-site responsibilities
Experience in a complex healthcare delivery environment, including clinic operations, financial management, quality management, risk management and business growth and development, preferably within a large medical group
Excellent leadership skills including ability to think strategically, develop vision and execute for results
Knowledge of regulatory and compliance healthcare requirements
Proven ability to drive organization innovation and change
Experience working in a large highly matrixed organization, with proven ability to develop internal enterprise relations and external relationships within the medical community
Excellent presentation and communication skills
Ability to make sound business decisions by analyzing financial and quality metrics as well as develop practical solutions for metric goal deviations
Strong business and financial background with a sense of urgency and a desire to achieve top line results
Extensive experience with advanced data management, tend analysis, statistical reporting, dashboard creation, report design and development, etc

121

Clinical Operations Specialist Resume Examples & Samples

Position Functions (Include no more than 10 functions) % of Position
Assist Global Site Management group with supporting the financial/contractual planning, organization and operation of global clinical studies
Assist Global Site Management group with maintaining accurate and complete essential documents and financial records for global clinical studies
May assist Global Site Management group with the preparation of budgets for global study protocols
May assist Global Site Management group with the annual needs assessment process and SWAT entries and modifications
Assist Global Site Management group with managing invoice payments; may interact with finance department; assist with reviewing monthly cost center reports and spend
May interact with legal department to assist Global Site Management group with managing the Clinical Trial Agreement, Non-Disclosure Agreement, and Financial Disclosure process; collect W8 BEN-E and W-9 forms as directed
Assist with the process of managing Global Clinical Development vendor management/indirect procurement process
Follow SOPs; assist with implementing new processes and improving existing processes as directed
Assist with preparation of email/written correspondence to the clinical investigational sites regarding contracts/agreements/budgets/payments for global clinical studies
Assist the Global Site Management group with communicating with the clinical investigational site staff for contract/budget negotiations

122

Global Clinical Operations Country Director Italy Resume Examples & Samples

Define long term strategy for the Italy aligned with GCO and Janssen R&D strategies in order to position Italy to achieve success
Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness in Italy
Ensures all operational objectives are met in conformance to all relevant ICH-GCP regulations, guidelines including Health Care Compliance, and internal SOPs, Work Instructions, and Policies
Appropriate and timely issue escalation to regional, global leadership. Report (suspicion) of fraud or scientific/ethical misconduct
Primary point of contact for Health Authority agencies for activities related to clinical operations
Build strong relationships with Local Operating Company staff incl. Medical Affairs, Commercial leaders. Might participate in the Local Operating Company Management Board and in Regional Management Teams
Build strong relationships with Regional Therapeutic Area Experts, GCO Early Development & Clinical Pharmacology, and GCO Medical Affairs regional leadership, Local R&D Heads of other countries in region, Program Delivery Operations (PDO) leadership, Integrated Data Analytics and Reporting (IDAR), Clinical Supplies Unit (CSU), Quality and Compliance, and external vendors locally
Contributes to shaping an attractive clinical trials environment through active involvement with Pharma Industry Associations, Medicines Agencies, Health Authorities in Italy
Leads metrics review and necessary follow-up actions
Leads and/or contributes to the design, development and evaluation of the Clinical Operations processes and standards to improve clinical trial management. Ensures rollout of new procedures
Responsible for the approval and oversight of the Country Quality Plan
Back up to regional leadership
Evaluates and projects overall resource needs for Italy and requests resources as appropriate
Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company policies supported by documentation of training compliance in Learning @ Pharma R&D
Oversees staff in local Health Authority site inspections and follow-up activities including CAPA generation
Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization)
Language Knowledge: Very high and fluent in English
Strong knowledge of MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).Clinical Trial Coordination

123

Clinical Operations Department Assistant Resume Examples & Samples

To organize in-office & out-of-office department meetings including the support for preparation and distribution of the meeting agenda and taking of the meeting minutes
To give support to the CTCs & Investigator Meeting Organization
To make travel and accommodation arrangements for the whole Clinical Operations Department members
To manage the local archive room of Clinical Operations Department
To meet the stationary and general needs of Clinical Operations Department
To organize the promotional materials and to distribute them to the relevant partners
To manage the "Investigator Satisfaction Survey" process in cooperation with Head of Clinical Ops and CMLs, when needed
To keep the e-tracker and individual training files of the Clinical Operations Department up-to-date
Initiation and actualization of the investigator payments & institutional payments with the support of CRAs/CML
Adherence to national and international regulatory and legal rules
Adherence to scientific and ethical standards
Compliance with BI internal SOPs and Guidelines
Support continuous improvement of internal processes, tools and solutions
To support Clinical Operations Manager for the performance management of Site Coordinators via BISCOM system

124

Clinical Operations Leader Resume Examples & Samples

5 years of clinical trial project management
Oversees clinical aspects of study as directed by Clinical Operations Leads including: Proactively identify and work with CRO to resolve clinical project issues
Oversee key clinical vendors, working with the COL to understand the landscape for reporting, regulatory requirements and related submissions. Also provides oversight of the CRO management of several external vendors, including laboratory, endpoint vendor, study communication vendor, and others as identified
Conduct close oversight of CRO work on country and site activations to ensure that sites are brought on as rapidly as possible and that the sites have all appropriate approvals and training completed in conjunction with site initiation visits
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs, and ensures that the study is conducted with a focus to being inspection-ready as any given time point
Reviews and approves clinical invoices against approved budget
Oversight and review of metrics and other key study reporting from CRO, including setting clear reporting expectations, monitoring receipt, review of outputs to identify issues for escalation, suggestions for improvement
Work with CRO to track and oversee the patient recruitment in the main study and the sub-studies, managing to established enrolment baselines
Oversight of the TMF in support of the COL

125

Clinical Operations Specialist Resume Examples & Samples

Experience in finance: forecast, actuals, cost reconciliation, a plus
Strong technical and organizational skills (excel, MP,), Details oriented
Demonstrated ability to establish effective working relationship in a matrix and multicultural envi-ronment
Strong customer oriented mindset 8. Willingness to act accountably in project / trial management

126

Principal Clinical Operations Specialist Resume Examples & Samples

A minimum of and 6 more years industry-related experience, with experience in clinical scientific background, clinical operations in research setting
Prior experience in Biomarker Research and translation research is strongly preferred
Strong knowledge and understanding of clinical research, ICH GCP, GLP, data management, and regulatory and legal issues related to acquisition of samples is required
Strong understanding of global shipping and clinical regulations is preferred
Strong ability to write work guidance and author SOW’s or SOP’s or scientific document review is required
Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix2951170315

127

VP-clinical Operations Resume Examples & Samples

Serves as the key operational contact for the Clinical Director (CD)
Facilitates communication between the CD and all departments and services reporting to the CD, senior management, and external contacts
Provides operational leadership for departments reporting to the CD
Ensures implementation of recommendations resulting from programmatic and service analysis
Under the direction of the CD, oversees corrective action for achievement of patient and program goals
Works in collaboration with departments and services reporting to CD
Motivates managers to achieve success through collaboration
Works with the CD to ensure that services are delivered so as to achieve the highest level of customer satisfaction, based upon the input of persons served
Guides the development of annual budgets for all departments reporting to the CD, working with CD, CFO, department heads, and other administrative points of contact
Monitors revenues/expenses to assure the respective departments achieve budgetary goals
Reviews monthly reports of budget variances and analyzes financial information for cost effective resource utilization to reduce unit cost of service consistent with optimal patient care
Analyzes volumes, quality, and outcomes, patterns of utilization, and scope of service in coordination with CD, senior management, and other administrative points of contact
Receives timely, accurate and meaningful reports from the departments and provides regular status reports to the CD and/or senior management
Assists with the preparation of status reports for the Board and for other presentation purposes as required
Liaises with the Graduate Medical Education committee and Academic Programs
Serves as a resource knowledgeable of the operational requirements for maintaining accreditation and ensures that processes are properly maintained
Works with CD, Chief Administrative Officer (CAO), department heads, and other administrative points of contact to ensure compliance with regulatory agencies
Submits information and reports to CD, CAO, and/or senior management to resolve issues
Supports the implementation of a comprehensive plan for the recruitment, retention and management of staff for the office of the CD
Leads the negotiation, coordination, execution, and compliance of contracts for designated on-site and off-site services; ensures that contractual requirements/stipulations are administered and met
Contributes to implementation of strategic planning and process improvement initiatives working in collaboration with senior management and administrative points of contact of departments and services
Leads groups to develop recommendations for executive approval/action and complete assigned projects
Maintains and pursues professional development on a continual basis relative to healthcare management, pediatric oncology, clinical research, and other related topics
Monitors and ensures the quality, services, and systems within the departments and services reporting to the CD
Monitors the local, regional and national health care environment
Develops and maintains external relationships with researchers, clinicians and management at other institutions
Identifies opportunities for potential business collaboration with external entities to support the institutional mission
Performs other related duties as assigned in order to meet the public policy goals and objectives of the institution
Maintains regular and predictable attendance
Five (5) years of management experience required
Hospital administration and/or private practice experience strongly preferred
Planning and organizing - Establishes courses of action to accomplish specific goals. Effectively and efficiently uses personnel and other resources. Able to revise plans to meet changing job demands
Healthcare – Has knowledge of all regulatory bodies that govern the healthcare industry, including JCAHO
Financial Management Skills - Capable of developing realistic budgets and auditing use of funds. Able to efficiently allocate resources
Interpersonal Skills - Sensitive to the needs, ideas, and feelings of others. Develops and maintains rapport with others. Varies approach with others taking into account their needs, cultural background, language ability and motivations. Respectful of others. Listens well and displays empathy for others
Communication - Clearly and effectively communicates ideas and requests to others, taking into account possible language and cultural barriers. Complex or sensitive issues are clearly stated
Leadership/Team player – Participates as part of Senior Leadership Team to continually advance institutional goals. Challenges ideas of others in ways that preserve morale, yet achieve objectives. Maintains a level of enthusiasm that encourages others to participate. Takes the initiative to assist as required. Accepts work assignments without complaint. Builds trust among co-workers and others

128

Clinical Operations Specialist Resume Examples & Samples

Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out
Ensure timely execution of studies in accordance with GCP and Allergan’s SOPs
Assist in development of case report forms in collaboration with clinical team
Support site and vendor selection activities
Review study monitoring plans
Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system
Review eCRF completion guidelines and lab requirements
Work with Data Management and Clinical Standards to ensure data collection meets standard
Develop and deliver study specific training presentations at study start and provide ongoing training to the sites during study conduct, as needed
Review/author informed consent forms and support their submission to IRBs
Author/review study procedure manuals, pharmacy manuals and/or laboratory manuals
Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Conduct study team meetings as appropriate; support the timely execution of milestones and discuss important study related information
Work closely with Bioanalytical Sciences department for pharmacokinetic/pharmacodynamics sample collection and processing activities for all clinical study phases (phase 1 through post-marketing)
Document and track protocol deviations and violations
Report high-level issues to Clinical Pharmacologist and Safety Physician with an organized approach Provide viable options for resolution based on prior experience and current study trends
Respond to site and vendor issues
Generate and resolve data queries in EDC. Participate in SAE reconciliation with clinical team
Review and respond to Sponsor site audit findings
Work with Contracts Management/Procurement to review and execute site and vendor contracts
Coordinate successful transmission of all study data
Perform clinical data review of data listings and summary tables; review queries
Ensure completion of trial master files
Review drug packaging and labeling and oversee the shipment of drug supply to ensure delays do not occur
Track and manage study budgets and accruals efficiently and provide timely resolution to financial inquiries
Participate in the preparation of clinical trial synopses/outlines and protocols
Participate in process improvement activities
Create/revise SOPs related to clinical study operation activities
Provide support during CSR development, such as review of TFLs and CSR and availability of certain CSR components
May perform study monitoring, create/review study monitoring plans, and prepare monitoring visit reports, confirmation letters, and follow up letters
CRA Training from a national clinical research association (e.g., ACRP, Barnett International, PERI) is desirable

129

Clinical Operations Coordinator Resume Examples & Samples

Supervises assigned personnel to ensure quality patient care, including forms and procedures as required
Monitors clinic workflow and schedule to ensure productivity standards are met
Evaluates performance and recommends merit increases, promotions, and disciplinary actions, assists in interviews, trains, and orients staff
Ensures that office space, supplies, assistance are provided and maintained appropriately for medical staff and patient care
Works with senior management to ensure operations and relations are effective
Ensures personnel forms and / or records are kept updated and submitted to other departments in a timely manner
Ensures that offices for new and incoming physicians are ready and equipped
Coordinates staff work activities and serves as resource to medical management staff in various market(s)
Collects clinic performance and quality metrics and produces reports for management
Orders office and medical supplies and ensures sufficient quantities are maintained at all times. Assists the Clinic Administrator in budget preparation and adherence
Coordinates conference calls and assist with preparation for meetings for medical management staff in market
Bachelor’s degree in Healthcare Administration, Business Administration, Nursing or related field (4 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor’s degree)
Two or more years of clinic operations or healthcare experience, including one year of supervisory experience
Knowledge of organization policies and procedures and ability to apply principles to solve everyday problems in a variety of situations
Skill in gathering, analyzing, and evaluating data
Professional healthcare license or certification
Strong knowledge of Microsoft Office applications, including Excel

130

Clinical Operations Consultant Resume Examples & Samples

Ability to analyze large data reports in order to identify trends or issues
Strong organizational and problem solving skills with ability to handle multiple priorities while working with little to no supervision
Proficient in Excel including complex formulas and pivot tables
Clinical or Prepay experience/knowledge
Claims processing knowledge and understanding of CAS and MTV platforms
Working knowledge of SQL

131

Clinical Operations Lead Resume Examples & Samples

Main point of contact in Clinical Operations for the Oncology Life Cycle Team
Works closely with the Clinical Science Lead and Medical Affairs Lead as part of the Core Clinical Research Team
Accountable for the planning and execution of all phases of clinical studies
Works closely with Clinical Operations project teams to support the planning, implementation and execution of clinical trials
Plans, implements and executes clinical trials to support regulatory submissions for clinical claims as well as claim expansion of products for RMS; other trials include those required to generate preliminary data leading to design of effective trials for product registration
Plans, implements and executes additional post-launch clinical trials of CE-marked and/or FDA approved/cleared products
Works independently and is highly autonomous
Represents the department at cross-functional project teams, and business unit/area and divisional levels
Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
Fully accountable for the results and achievements of the area
Regularly interacts with executive management on work of area(s) that impacts larger organizational goals
Frequent interaction with internal and external CLIA/CAP labs
Implements global study support strategies and initiatives
Oversees sample requirements for studies and works closely with Bio-specimen Management (BSM) team to acquire specimens for use in clinical studies
Supports the preparation of reports and summary documents (for internal and/or external customers/partners) for product registration
Supports Clinical Science Lead by developing and managing overall study budgets along with budget and contract negotiations with study sites, central laboratories and CROs
Prepares and tracks resource demand (both internal and external/outsourced) and study timelines with shared accountability with Clinical Science Lead
Ensures adherence to regulations, guidelines and departmental standard operating procedures on the part of direct reports and project team
Monitors the performance of outsourcing services through KPIs, as applicable
Maintains a high level of professional expertise through familiarity with scientific literature, Roche product portfolio and competitive environment
Represents RMS in hospitals and labs, and interacts with Key Opinion Leaders, Investigators and other key customers in the field of Sequencing
Provides technical input to study designs and clinical development plans
Supports the preparation of clinical study proposals, protocols, reports and manuscripts
Works with Data Management and Biometrics statistics staff on the design of documents and processes for the collection of study data from participating sites
Supervises, mentors and trains Clinical Operations personnel at all levels, including: Sr. Manager, Managers, Clinical Research Monitors, CRAs, Sr. CRAs and/or Principal CRAs
Ensures compliance of direct reports with Good Clinical Practices, worldwide regulatory requirements, SOPs and study protocols
Collects and maintains Legal and Regulatory documentation, as applicable
Ensures accurate and complete study management/data collection and transfer into the data management system
Ensures site compliance with regulations and study protocol
Acquires and maintains technical knowledge of product line
Aligns processes and resources with other business areas (Roche Molecular Solutions, Roche Tissue Solutions, Roche Professional Diagnostics and Roche Pharma) where applicable

132

Senior Director, Ltss Clinical Operations Resume Examples & Samples

Develop and oversee contracted services function as liaison between UPMC and other non-UPMC contracted network facilities to ensure successful program management Develop and oversee coordinated approaches to Medicare and Medicaid delivery to foster integration and improved member experiences including case management, utilization management, and holistic member engagement. Communicate effectively in individual and group situations to ensure optimal implementation, and processes, interface with both internal and external providers, regulatory and compliance auditors, staff and members
Develop tactical strategic plans for business units to optimize efficiency and achieve corporate business objectives. Analyze and trend data to identify area of opportunity and implement process improvements. Manage oversight, management and documentation of medical management quality work plan and annual program evaluation related utilization metrics and budget targets, quality metrics and regulatory requirements and as related to the technology utilized in the medical management department
Develop, monitor and manage budgets related to clinical operations, system support and implementation projects. Manage production, quality audit and management of reporting produced from the medical management department for external reviews for Health Management, i.e. DHS, DOH, CMS Medicare reviews. Proactively identify risks and work with management staff to mitigate risk and implement corrective action plans as necessary. Ensure operational performance within the clinical operations support area through analysis, critical decision making and implementation of automated solutions
Manage all aspects of Community HealthChoices service delivery. Responsible for oversight of home and community-based services including service coordination. Establish and oversee home and community-based services training in accordance with the care model across internal and external staff. Work in close collaboration with the Community HealthChoices, Medicare, and D-SNP product teams. Work in close collaboration with clinical leadership responsible for and with impact on D-SNP membership, institutionalized members, and the community team
Partner with Information Systems management personnel to evaluate technology solutions, custom development and/or system implementation for internal and external customers. Continuously evaluate and manage documentation of customer needs and all aspects of business processes to assure systematic processes are being utilized to capacity to optimize system efficiencies. Analyze, evaluate and present information concerning factors, such as business situations, production capabilities and design and development of system processes to all customer levels within the organization
Work with Senior Management to achieve efficiencies across integration of projects. Develop and maintain work plans which include time, resource allocation, testing and implementation of new business, medical management programs or technology. Represent clinical services on internal and external forums and committees, as requested. Direct the liaison functions between the UPMC Health System and other network providers to ensure successful service coordination and utilization management processes. Direct all processes implementation activities related to case management
Five years experience supporting care coordination of long-term services and supports
Five years of experience in management and in health care insurance or health care industry with regulatory, compliance and information system knowledge
Experience with Medicare/Medicaid integration and Medicaid managed long-term services and supports preferred
Proficient knowledge in MS Office and PC skills required
Ability to demonstrate excellent organizational, interpersonal and communication skills
Strong project management, problem-solving, organizational, and communication skills (oral and written) are required
Ability to perform planning for large initiatives/projects, as well as manage all tasks required to meet departmental and business needs within budget and targeted deadlines
Strong leadership skills and independent decision making ability

133

Director, Global Phase, Clinical Operations Resume Examples & Samples

Reviews clinical data, analysis and medical observations to arrive at sound conclusions
Provides expertise in developing the overall clinical program operational strategy and ensures that program specific standards are developed and applied across trials to ensure consistency
Directs the preparation and establishment of Master Services Agreements and Task Orders with CROs
Directs and manages the preparation of clinical study reports
Directs the development and approval of all clinical data/information to support IND, NDA, and Health Registration Dossier (HRD) submissions
Assuring clinical studies are conducted by the CRO in compliance with the protocol, Good Clinical Practices, and appropriate federal, state and local requirements, conducting or overseeing audits of CRO performance
Directs and manages operational study designs and oversees implementation in order to meet established budgets, goals, and milestone schedules
Assists in clinical operations resource planning
Coordinates and supports program level inspection readiness strategies in preparation for and defense of global regulatory filings
Bachelor's degree or equivalent
5-8 years of Clinical operations supervisory or management experience
Expert knowledge of the pharmaceutical industry, disease management, drug and device law, industry and government trends is required
Comprehensive knowledge of FDA and International Agency guidelines, SOPs, GCPs, GMPs, GLPs and GXPs
Advanced knowledge of clinical trial operational design, clinical operations, outsourcing, and the clinical drug development process
Excellent skills in designing and managing global clinical trials and the ability to contribute to the operational clinical strategy for assigned program(s)
Must possess significant experience in managing multiple projects
Must demonstrate strong skills in forming and leading the clinical program team and working with other functional areas and external stakeholders (i.e. clinical investigators, CRO & Vendor personnel, etc.)
Light. Some physical demand. Often lifts light-weight material up to 20 lbs. May involve walking, standing, carrying, pushing, and/or pulling

134

Clinical Operations Performance Improvement Senior Principal Resume Examples & Samples

Identifies, assesses and solves complex business problems for area of responsibility, where analysis of situations or data requires an in-depth evaluation of variable factors
Closely follows the strategic direction set by senior management when establishing near term goals
Interacts with senior management at a client and/or within Accenture on matters where they may need to gain acceptance on an alternate approach
Has some latitude in decision-making. Acts independently to determine methods and procedures on new assignments
Decisions have a major day to day impact on area of responsibility
Remains highly relevant in area of expertise and educates colleagues on industry and regulatory updates and best practices
Demonstrates the ability to develop a leading edge and recognized point of view
Manages large - medium sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Advising and delivering transformational care management, social work, physician advisor, multi-disciplinary rounds, and patient throughput initiatives across complex, large-scale healthcare Payers or Providers and for contributing to the design and implementation of solution offerings
Leading relevant clinical and process change methodology development by leveraging current healthcare Payer and Provider industry research, internal and external relationships, relevant technological and analytical trends, and past project experiences
Building and developing healthcare Payer and Provider nurse, physician advisor, care management, social work, clinical care team and clinical leadership client and vendor relationships
Representing Clinical Operations Performance Improvement practice in key industry associations and at industry relevant conferences responsible for identifying industry trends, potential practice solutions, building external relationships, and co-presenting practice thought leadership and project results
Shaping and delivering Clinical Operations Performance Improvement projects across Care Management, EHR Optimization, Capacity Management, Standardization of Care and Clinician Engagement offerings and services
Implementing and coaching key clients on the recommended changes to organization, governance, operations or project/initiatives
Implementing plans and working collaboratively with project teams to execute project deliverables on target, on time and on budget
Assessing and managing risk throughout the project lifecycle and adjusting as needed to ensure planned business outcomes are achieved
Providing direction in collaboration with client Executives, managing client expectations, and negotiating among key stakeholders to yield win-win outcomes
Authoring or making significant contributions towards innovative, thought leadership expressing Accenture’s POV in the market
It is our intention for our people to work where they live. However, in the context of our profession and serving our clients there may be times when you will need to travel
Minimum of 5-10 years of Care Management and/or related Nursing experience in clinical acute-care setting with minimum of 2 years Management experience
Minimum of 5-10 years using and training InterQual® and/or Milliman Care Guidelines® evidenced based clinical guidelines
Minimum of 3 years external consulting experience
Knowledgeable of Commercial, Medicare, Medicaid, and other payer related laws, regulations, and policies
Understanding of clinical denials (e.g., medical necessity, patient status) payor and provider operations and best practices
Experience in inpatient, observation, ICU, behavioral health, mom/baby, surgical, and/or emergency department provider settings
Proficient with care management and social work models, staffing, and performance accountability metrics best practices, especially related to utilization review, discharge planning, and transition of care processes
Experience working with and developing Physician Advisor relationships
Bachelor’s degree in Nursing or healthcare related field required
Registered Licensed Nurse (RN) and/or Certified Nursing Case Manager (CCM)
Master’s degree in Nursing or healthcare related field
Project management and/or supervision experience, leading clinical teams
Previous consulting experience working in a team environment
Strong executive communication skills
Population health management strategy, design, and/or implementation experience
Understanding of electronic health records and care management technology systems
Coaching experience, training and mentoring others
Excellent leadership and management skills
Demonstrated initiative to independently drive results
Problem solving and critical thinking skills
Emotional intelligence, agility and ability to adapt to a wide variety of professional situations

135

Director of Clinical Operations Resume Examples & Samples

Serves as a resource, role model, and mentor for the DON and other key clinical leaders within the Continuing Care (including but not limited to DON, ADON, Wellness Manager, Quality Care Coordinator, MDS Coordinator, SDC, Assisted Living Managers and Memory Care Managers)
Assesses and evaluates the effectiveness of processes, systems, and care delivery to residents/guests ensuring to meet Erickson Quality of Care Standards and providing recommendations for improvement as needed
Support and ensure the implementation of Erickson approved clinical programs, practices and policies for Short Rehabilitation /Post Acute Care, Long Term Care, Assisted Living and Memory Care
Ability to provide consultative/corporate support to Ancillary Business Lines (Home Health, Hospice, etc.) to support an integrated approach to care
Identifies the possibility for new, or revision to, policies, procedures, protocols and programs and communicates them to the VP of Clinical Services
Participates in the development, implementation and ongoing evaluation of clinical priorities in CC
Provides support and guidance for implementation of Memory Care Programing within the Memory Care neighborhood and throughout the CC
Visits each CC is in accordance with defined Erickson standards to review and/complete systems reviews of care delivery and clinical systems to include
Maintains knowledge of applicable state and federal regulations and Erickson policies and procedures
Maintains knowledge of approved electronic medical records system

136

Head of Clinical Operations Resume Examples & Samples

5+ years of prior Management experience
Experience in the Healthcare industry
Previous experience with Strategic Planning and Budget Management
Previous experience working within a Start-up and/or Healthcare Technology firm

137

Clinical Operations Supervisor Resume Examples & Samples

Responsible for coordinating and overseeing the daily activities of the LSA / PSR staff
Responsible and accountable for determining the LSA / PSR staff preparing work schedules, and rearranging work schedules of the LSA / PSR staff to compensate for work load and personnel shortages
Assists with personnel hiring, evaluating job performance, terminating, and counseling
Responsible for coordinating and ensuring that the staff receives proper orientation, continuing education classes and any additional appropriate training
Assist the Regional PSU Manager in monitoring expenses and payroll for staff
Responsible for monitoring production of work for the LSA / PSR staff
Maintains and strengthens the relationships with the PSU team and collaborates with Market PBM’s, Contracted Provider and Market Quality team
Serves as the representative / liaison for the PSU team in the absence of the Regional PSU Manager
Monitors Logistical paperwork coming into PSU and gives weekly updates to corporate on stats for paperwork turned into PSU
Creates and Monitors Accuracy Corporate Reports
Runs Team Huddles
Responsible for oversight and updates to PSU Policies, Procedures, and Processes
1+ years of healthcare experience with increasing responsibility
At least 2 years Supervisory or Lead experience within an office setting
1 year of clinic operations or healthcare experience
Working knowledge of Microsoft Office applications, including Excel
Knowledge of fiscal management and human resource management techniques
Knowledge of office management techniques and practices
Skill in written and verbal communication
Ability to exercise initiative, problem solving, decision-making
2+ years of related experience in a clinic setting

138

Clinical Operations Patient Engagement Specialist Resume Examples & Samples

Operational Leader for Innovative Patient Engagement across the US Pharma Clinical Development and Medical Affairs organizations
Identify digital and non-digital approaches to patient engagement within US clinical trials
Guide Clinical Operations teams in the utilization of patient centric innovations
Develop and deliver tactics and tools to positively impact Investigators and their patients in US clinical trials
Work with Clinical Teams to identify and implement appropriate patient engagement strategies within large clinical programs and individual clinical trials
Work closely with Clinical Development and Medical Affairs teams to obtain patient input into protocols and trial feasibility
Lead CDMA partnership with internal Advocacy and Communications and Patient Affairs/Policy teams in relation to clinical trial patient engagement. Create strategy for US CDMA optimization of Voices of Inspiration capabilities
Create and lead strategy for external partnerships with patient engagement organizations (i.e. CISCRP, Patients Like Me, Inspire, etc)
Oversee local vendor selection, onboarding and performance. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
Responsible for developing, tracking and reporting metrics/KPIs to the US CD&MA Leadership Team in collaboration with US Clinical Operations leaders
Accountable for the forecast, allocation and tracking of budget
May be involved with special projects and work streams
7 years working directly in the area of clinical trial execution or clinical trial patient engagement with country and/or global experience
Excellent understanding of all aspects of clinical drug development with particular emphasis on patient recruitment, trial execution and monitoring
Demonstrated leadership across teams with the ability to influence and direct others within a matrix environment
Thorough understanding of with general health authority, GCP and ICH requirements
Excellent communication and presentation abilities and skills

139

Manager Regional Clinical Operations Resume Examples & Samples

Institutes corrective action when appropriate and notifies DCO and Human Resources (HR) on disciplinary action for any employee
Understands and continually evaluates Care centers for HIPAA compliance
Verifies annual CLIA, equipment calibration, and Business License application and renewals are completed
6 years of experience in the management of a large medical practice with multiple locations, including experience in an outpatient healthcare setting; or any combination of education and experience, which would provide an equivalent background

140

Manager of Clinical Operations Resume Examples & Samples

Develops processes and oversees maintenance for clinic adherence for anemia management, adequacy management, catheter reduction, and mineral bone metabolism. Ensure co-morbid conditions are documented
Mentors and assists facilities in identifying effective practices applicable to their needs, in testing for desired results and the adoption and implementation of practices, to include, but not limited to; epo weighted dose management and improvement, missed treatment intensive and FMCRX
Assesses, reports and assists in reduction of stat lab usage as appropriate
Identifies champions within clinics assigned for various initiatives or core Mitigation Services Division directives
Develops and assists in maintaining processes for clinics to maintain efficient staff and patient scheduling
Conducts facility risk assessments to identify opportunities for improvement, develop plans, and evaluate effectiveness of improvement activities
Conducts exit conference with facility management staff to review risk assessment results and evaluation of QAI programs effectiveness
Provides guidance for developing action plans. Ensures action plans are followed up on and completed
Develops processes and maintains/oversees all clinics Crown Web and NHSN adherence
Reports to the RVP of region and identifies any red alerts and reports immediately
Educate Facility Managers on the completion of routine internal QAI reviews to identify risk areas
Responds to emergent requests to investigate, intervene and assist with resolution of a facility specific problem including clinical variances and serious adverse advents
Fosters and maintains good working relationships with state survey agencies, CMS regional offices, ESRD, and other regulatory bodies that have jurisdiction over FMCNA facilities
Provides guidance and oversight in development, completion and effectiveness of Plans of Corrections (POC) related to CMS, State, OSHA, FDA and other regulatory surveys as well as internal audits
Stays abreast and utilizes current knowledge of FMC clinical and administrative policies for the Mitigation Strategies Division
Collaborates with the Mitigation Division Representatives of the Medical Advisory Board to conduce activities that promote and advance the QEMP relating to improvement of clinical outcomes
Responds to facility and Mitigation Division management regarding clinical policies and procedures, clinical standards as well as professional practice and regulatory licensing issues. Provides guidance, interpretation and subject matter expertise
At least 5 years experience in managing and leading groups, preferably in healthcare
Maintains knowledge of technical and clinical aspects of the dialysis business

141

Head of Clinical Operations Resume Examples & Samples

Primary leadership role for overall clinical operations strategy across multiple early phase oncology clinical research trials
Provide strategic and tactical input into clinical development timelines; develop study specific goals, track metrics, and produce executive summary reports
Responsible for program activities and program management; ensuring all clinical trials are executed per key metrics (timelines, budget, operational and quality standards (ICH/GCP/ SOPs and procedures)
Lead all aspects of study planning in collaboration with CROs (establish study feasibility, set quality expectations, Gantt charts, etc.)
Set department goals and objectives which align with broader company goals
Provide leadership and oversight to Clinical Operations department and develop direct reports (Clinical Trial Managers, Clinical Scientists, and Clinical Supply Managers)
Direct authorship and review of protocols, clinical study reports, Investigator Brochures, etc
Represent the company to external audiences in the clinical, financial, and pharmaceutical industry communities and organizations
Generate and track study and departmental budgets. Author standard operating procedures (SOP) for Clinical Operations that are compliant with clinical/medical and industry standards
Generate operational standards, processes and systems and ensure consistent implementation across trials
Identify and develop collaborative relationships with key investigators and key opinion leaders globally. Attend and oversee clinical advisory boards and investigator meetings
Critically review regulatory submissions (such as INDs and DSURs)
Minimum education: M.S. / B.S. in a scientific discipline
Strong leadership and collaborative interpersonal skills
10 + years of experience in leading clinical trials execution
Knowledge of safety reporting principles, including global safety reporting regulations
Able to perform thorough reviews of various medical and legal documents in a timely manner
Proven ability to interact, train, and build strong relationships with CROs, vendors
Familiar and comfortable with current Good Clinical Practice, as well as FDA and international regulations
Proven experience in managing and leading cross functional teams, internal and external
Possess strong critical thinking and problem solving skills
Detail oriented with proven program management expertise
10-15% domestic and international travel to clinical trial sites, investigator meetings, regulatory bodies, etc. may be required

142

Senior Clinical Operations Specialist Resume Examples & Samples

A minimum of a Bachelor’s degree is required
A minimum of 5 or more years industry-related experience, with experience in clinical scientific background, clinical operations in research setting
Good understanding of human physiology, pharmacology and biomarkers is required
Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix8452170421

143

Coordinator, Clinical Operations Resume Examples & Samples

Communicate verbally and electronically with health plans and interacts with members, plan representatives and providers as required
Provide operator backup
Process incoming and outgoing faxes as needed
Document outcomes and actions related to task according to departmental documentation standards

144

Director of Clinical Operations Resume Examples & Samples

Full responsibility and accountability for clinical operations in Radiation Oncology, including Radiation Oncology at Needham
Full responsibility and accountability for Nursing staff and Administrative Staff for all Radiation Oncology physician offices in addition to clinic admin staff
Responsible for the implementation of all new ventures/ programs within Radiation Oncology
Develop policies and procedures for Radiation Oncology and work with interdisciplinary teams to improve access through specific efforts aimed at increasing capacity to support demand and growth and developing open access practice models
Responsible for Revenue Cycle initiatives and funds flow by working with Fiscal, Information Systems, Registration, Chief Administrative Officer, Practice Administrator and front line staff to implement the process of training, development and rollout of charge ticket entry, and referral management
Designated Leader for multidisciplinary programs and partners with other members of the management team within and outside of the department to initiate and oversee new multidisciplinary programs and projects
Hires, develops, supervises and evaluates staff which can include Nurse Practitioners, Clinical Advisors, RNs, Practice Administrators, Administrative and Clinical Support Staff, and Emergency Off Site Techs. Participates in the selection and evaluation of individuals for leadership positions
Assures that department activities and records meet the standards of accrediting, regulatory or reimbursement agencies
Establishes ongoing communication mechanisms with patients, staff, physicians, as well as the hospital and referring communities through regularly scheduled meetings and other forms of written communication
Has the responsibility to lead and support managers and directors in developing and improving operations to create optimal performance levels. Direct Reports: More than 7 Indirect Reports: 6-10
Assists in planning, monitoring and managing budgets for multiple departments
Bachelor's degree required. Master's degree preferred
License Registered Nurse required
3-5 years related work experience required and 3-5 years supervisory/management experience required
Demonstrates proficiency in the area of process improvement and system redesign. Specific experience in data and systems analysis, quality management/performance improvement
Excellent skills in interpersonal and written communication
Demonstrates proficiency in budget and human resource management

145

VP, Clinical Operations Resume Examples & Samples

Organizational Leadership
In collaboration with executive management and medical directors, identify opportunities to improve the efficiency and effectiveness of CSMN practices while maintaining high standards of quality patient care
Direct the overall operations of the patient care programs and services and ensure effective communication and coordination of services
Implement standardized policies, procedures and processes across sites to achieve reduction in overall variability in care processes. Initiate and implement workflow modifications and process improvements to reduce variability in care processes across sites
Oversee the operations of assigned medical groups to include financial management, physician relations and personnel management. Scope of responsibility encompasses physicians, allied health professionals and staff across diverse medical and surgical specialties
Provide direction and leadership in the design and implementation of new and innovative models of care and the supporting technologies that improve efficiency, quality, patient satisfaction and physician satisfaction across the organization
Represent the Medical Delivery Network on a variety of Health System initiates, including Financial Improvement Task Force, CS-Link Physician Revenue Cycle Steering Committee, Advance Care Planning and Physician Practice Transformation
Lead efforts on behalf of the Medical Network in promoting and improving workforce excellence and talent management across the organization to include staff, physicians and allied health professionals
Engage in other operational activities in support of the strategic plans of the organization
Clinical Practice Management
Oversee operational management team managing physician practices within the Cedars-Sinai Medical Group and affiliated medical groups as assigned. Responsible for recruiting, orienting, training, coaching, evaluating, counseling and exiting direct reports
Promote the concept of the patient care team, synthesizing the needs and activities of clinical and administrative staff and physicians with a focus on the patient experience
Implement and lead a continuous quality improvement process throughout the program and service areas
Work collaboratively with the leadership of Strategic Integration, Physician Recruitment, Network Development. Quality Improvement, Population Health, Utilization Management, Risk Management, and other departments to maximize clinical performance, minimize risk, and assist the Medical Network in achieving its goals
Plan, organize, and direct administrative (front office), clinical (back office), and health information daily operations of the medical practice(s) as required. Coordinate operations as needed between different facilities (e.g., staffing)
Ensure the appropriate staffing, equipment, and resources necessary for optimal patient care
Develop, reviews, and revise standard operating policies and procedures and related operational workflows, in collaboration with senior management
Serve as a resource to clinical operations management team for day-to-day personnel issues and other administrative problems requiring senior management review, input and advice
Provide direction and support to clinical operations management team in the integration of new practices and physicians to the Medical Network; ensure that all aspects of practice set-up are appropriately planned for and executed
Work collaboratively with key representatives across the Medical Network and Health System departments in the planning and implementation of new processes and systems in operations; provide direction and leadership to new implementations and process improvements
Provide leadership in the review of operational processes, develop and implement operational process improvements to support quality care, access and patient satisfaction
Direct team in the management of operational and special projects within scope of responsibility
Assume administrative responsibility over individual facilities in the absence of operations directors as requested
Perform related recruitment selection functions, orientation, training and management functions in support of individual facility operations
Management of Clinical and Ancillary Services
Executive oversight of all Clinical and Ancillary Services for the Cedars-Sinai Medical Network to uphold high quality patient care. This includes, but is not limited to, legal, regulatory and compliance requirements (e.g. CLIA, radiology, clinical equipment); infection prevention and nursing services, laboratory, radiology; regulatory audits (e.g. DPH, OSHA, Radiology); staff competency training, assessment and certification; vendor relations; clinical supplies; financial and budget planning; cross-departmental coordination with appropriate CSMC departments
Executive oversight of Health Information services in the Cedars-Sinai Medical Network, including but not limited to compliance with Health System and Foundation policies, procedures and protocols; compliance with state and federal laws, professional and regulatory agency standards and licensure requirements; health information audits; financial and budget planning; cross-departmental coordination with CSMC's health information department; staffing, recruitment and competency assessments
Management of Financial Resources
Responsible for the development of operating wage, non-wage and capital budgets in accordance with the budgetary guidelines. Provide leadership to management team in the development of site budgets and tracking against goals
Ensure physician practices function cost effectively while producing a quality service. This includes
Planning, proposing, and managing the capital and operating budgets
Developing, implementing, and improving resource management
Developing, implementing, evaluating, and improving production standards
Management of Human Resources
Provide leadership and effective supervision, coaching, and personnel management to all assigned employees in the Foundation
Lead a high-performing team by developing and implementing recruitment, training and retention strategies. Clarify roles and responsibilities; develop individual goals for staff and provide coaching and hold accountable for performance
Promote collaborative teamwork, open communication, and self-direction within the management team
Provide orientation and staff in-service programs to assure staff competency and address performance improvement issues
Provide management development and mentoring to manager, supervisor, and lead level employees
Oversee staffing operations with management team to ensure appropriate daily coverage in offices
Ensure coverage, including reassignment of management responsibilities, to provide appropriate oversight of all operational practice sites
Oversee internal operational recruitment processes, to include collaboration with Human Resources in the development of recruitment and sourcing strategies; interviewing; coordinating pre-employment requirements
Provide direction and oversight for all necessary paperwork and personnel actions with Human Resources. Includes processing of initial requests for recruitment, confirmation of new hire selection, and subsequent personnel action forms
Provide direction to management team in all staff employment requirements
Develop appropriate policies and procedures pertaining to staffing and per diem pool operations
Provide direction to management team in the placement of temporary personnel through agencies, to include management of vendor relationships, processing of invoices and maintaining monthly reports of staff usage and expense
Maintain own competency through membership in professional organizations and by obtaining continuing education
Patient/Staff/Physician Relations
Promote a culture of excellent service
Serve as a role model for excellent service in all interactions with internal and external customers
Resolve patient, staff, and physician inquiries and complaints, escalating issues to the CEO, COO, Vice President for Strategic Integration, Medical Director/Department Chairs, Quality Improvement, or Risk Management, as appropriate; provide mentorship to management team in the resolution of patient, staff and physician concerns
Actively and effectively partner with the physicians and clinical teams to promote office efficiency, quality of care, and performance improvement
Other Duties
Participate on committees and manages special projects as requested
Serve as liaison and collaborates with certain centralized functions (e.g., Finance, IT, Human Resources, Physician Billing Services, Facilities Management, Purchasing, Business Development, Marketing) on behalf of assigned Medical Groups; and other duties as assigned

146

Director of Clinical Operations Resume Examples & Samples

Knows, adheres and updates the clinical policies of the Centers
Directs and supervises nursing and ancillary personnel in planning, implementing, monitoring, and evaluating patient care in the Clinical area according to accepted standards, including JACHO and State of Nevada regulations
Participates in the recruitment, interviewing, selection and hiring of department employees
Monitors the staffing assignments and the OR schedule
Delegates coordination of department needs when out of the department
Facilitates and coordinates the orientation process for new employees
Provides direct patient care in clinical areas as needed and demonstrates necessary clinical competence
Is responsible for the safety and PI committee including quality improvement and safety responsibilities
Writes an annual performance appraisal of department supervisors based on job descriptions, center standards, policies and procedures
Demonstrates effective communication skills with staff, management, physicians, and patient/families
Fosters teamwork by collaborating with others in problem solving process
Gives verbal counseling in a timely manner and recommends further disciplinary action when needed
Holds and participates in meetings as required by the center
Plans and monitors staffing to meet budget
Monitors and minimizes use of department overtime
Assists administration with recommendations regarding capital budgets
Informs Administrator of applicable day-to-day situations
Responsible for Infection control, employee health and other personnel and staffing policies
Attends Partnership, PAB and MEC meetings as directed
And other responsibilities designated by the Administrator, Medical Director, Governing Body, MEC or Regional V.P

147

VP of Clinical Operations Resume Examples & Samples

Analyzes service line needs and opportunities for growth with regard to business development and new ventures, developing annual goals and objectives (divisional Balanced Score Card) that align with the Organization’s strategic direction and Balanced Score Card. Establishes priorities, eliminates impediments, and resolves problems. Monitors performance measures, provides leadership to his/her management team and staff that fosters continuous performance improvement
Evaluates treatment and child-care practices and protocols, in collaboration with the Chief Medical Officer, Medical Directors and clinical staff, assuring the use of evidence-based, and other proven, practices in all programs
Develops, with support of the Human Resources department, effective staffing plans and provides leadership that assures the recruitment and retention of a high-performing team of clinical and support personnel; establishes appropriate performance expectations, provides coaching and evaluates performance. Provides tools necessary for staff members to be successful in contributing to the achievement of individual and departmental goals. Makes hiring and disciplinary decisions in conjunction with managers and coordinators
Develops and is responsible for annual division and department budgets, working cooperatively with the CFO and Finance Department. Determines future resource needs, monitors actual progress, and makes adjustments as necessary to stay within budget, allocating resources to meet a changing environment
Identifies needs and provides opportunities for ongoing staff development. Collaborates with supervisor to identify self-learning needs and seeks out resources or instruction opportunities to meet those needs
Facilitates effective communications among staff members, management, and internal and external customers to ensure seamless services. Seeks opportunities to model teamwork in support of the Organization’s objectives
Plays a leadership role in quality/performance improvement initiatives and incorporates best practices within the clinical operations
Oversees positive customer service relationships by identifying customers and their needs, ensuring customers’ needs are met, responding appropriately to difficult interactions, and educating staff members on quality customer service. Maintains a positive, high profile with external and internal referral sources and funding partners
Serves as an active member of the Senior Leadership Team, providing support and assistance to colleagues in achieving organizational goals and advancing ongoing efforts to continuously improve the SLT as a high-performing team
Minimum of ten years’ experience with behavioral health, including chemical dependency preferably in a managed care and/ or private pay environment
Minimum of seven years’ management experience
Minimum of three years’ in a leadership/administrator role

148

Manager of Clinical Operations North Tenaya Adult Medicine Clinic Resume Examples & Samples

Technical support to nursing and front office teams
Oversight of business and clinical compliance, monitor business outcomes and financial business analysis
Works closely with providers and site RN leadership to optimize patient flow
Accountable to ensure strict adherence to policies related to financial integrity of co-pays, charge entry, Par levels etc
Recruits-retains outstanding staff; ensures overall competency of staff (directly supervises 11 personnel) ensure proper training, resource allocation and develop standards to monitor and evaluate staff performance
Educate staff and providers to monthly goals and areas for improvements
Maintains facility compliance with federal and state regulations and SMA policies and procedures
Responsible for facility planning and overall facility maintenance. Analyze monthly Key Indicator Reports relating to customer services, access and achievement of financial goals and objectives
Develop-maintain quality improvement strategies related to customer service and best medical practices
Ensures customer satisfaction within the clinic sites and resolves patient issues
Contribute to the development of short and long term business planning
Accountable for achievement of clinical and business compliance and licensure for labs, staff and requirements for regulatory compliance
Responsible for all safety functions in clinics and ensures completion of safety training and proper orientation for new employees
Bachelor's degree in Healthcare, BSN, Social Work, Business Admin or related field highly preferred and/or equivalent and relevant work experience
3+ years experience in healthcare environment mandatory (preferably in a clinic setting) with a bachelors degree
6+ years experience in healthcare environment in lieu of Bachelors degree
1+ years of Supervisor/Management experience with performance management functions required
1+ year financial and cost accounting required

149

Clinical Operations Initiatives Mgr-sds Resume Examples & Samples

Identifies issues and improvement opportunities in support of Board / system strategies, and develops solutions including tactics; costs; measures and outcomes. Leads or collaborates with others to define IT development and project management components
Develops and implements system and / or region education, communication and / or implementation plans associated with assigned system-wide initiatives
Coordinates internal resources to identify and operationalize internal and external related best practice initiatives
Collaborates with human resources, finance and management engineering, in developing and implementing activities related to projects
For projects requiring information technology / software solutions, coordinates with IT staff and clinical users, and provides ongoing evaluation to assure success. Recognizes barriers to project plans and determines mitigation strategies. Manages supplier relationships and product performance
Coordinates necessary resources to resolve complex problems and balances the focus on processes with appropriate outcomes
Collaborates with clinical program leaders and staff to ensure we both lead and support all clinical program initiatives
May facilitate appropriate external and internal communications related to projects (e.g., press queries, Intermountain Stories regular column, promotional strategies, etc.)
Establishes or develops appropriate metrics for initiatives for uses at a system, region or local level. Serves as a content expert and resource to all levels to provide support, education and clarity
Evaluates and quantifies the impact of implemented projects through available measurements relative to clinical process, outcomes, patient or staff experience and / or financial objectives
Oversees services and resources related to projects including RFP process and contracting reviews
Develops policies, guidelines and documentation relative to project initiatives
Leads and supervises department or program staff. Responsible for staffing, coaching, development, performance management, and administrative duties required of those in a supervisor role
May be responsible for the Patient Safety Improvement Program: Participates in the development and maintenance of the Intermountain Healthcare Quality and Patient Safety Plan
Content expert in Continuous Improvement methodologies with ability to facilitate and educate to the utilization of these tools and methodologies. Provides input and consultative services in the development, implementation and monitoring of patient safety improvement projects for the system and / or region and individual business units. Creates tools and resources to ensure standardization of improvement processes and monitoring

150

Director of Clinical Operations WFH Resume Examples & Samples

Director of Clinical Operations to work together with ICC Regional Director of Medical Operations providing analytical and logistical support, regular program site visits in designated geographic region, Clinical assessment and ensuring consistency of ICC Intensivist Program Model
In services ICU Nursing Director to the ICC program roll-out and implementation and TEAM building strategies
Facilitates streamlining of documentation efforts, Meditech integration and utilization of ICC order sets
Facilitated PQRS compliance and physician Healthstream course compliance
Participates in critical care, vent optimization and sepsis committees – reviewing Clinical Excellence Dashboard exploring and suggesting strategies to achieve best clinical practice in alignment with ICC and HCA programs
Provides Clinical Documentation Peer review – improving DRG coding accuracy and capturing accurate charges

151

Director of Clinical Operations Resume Examples & Samples

Supervises integration of ICC Intensivist Program by aligning the Intensivists and ICC Intensivist program policies with the ICU nursing staff – through in servicing of ICC protocols, facilitating communication amongst ICU team members and emphasizing compliance with key clinical initiatives
Director of Clinical Operations will provide direct oversight and supervision in addressing clinical corrective action plans and provide regular updates to the ICC and facility administration
Supervises new ICC Program implementation and integration – providing gap analysis and feedback
Provides oversight in patient hand-off, sign out process ensuring continuity of care and meaningful transition of care model
Improves rapid Response Activation Service: Adopting the ICC ADANCED RAPID RESPONSE PROTOCOL

152

Senior Associate, Clinical Operations Resume Examples & Samples

Participate in the planning of a study or multiple studies with the CRM
Perform operation and administrative duties assigned by the CRM
Assist with the CRO selection process and ensure contractual obligations are met
Assist the CRM with site study budget negotiations and payments
Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements. Contribute to development of a payment schedule section for Vendors and process/obtain approval from management
Assist the CRM as a lead CRA to study start up, study execution and close out activities
Assist in the development and coordination of protocols and informed consent forms
Assist in the planning and coordinating investigation meetings. Prepare and present protocol and general study-related presentation to field monitors, investigations and adequately informed of protocol requirements, standard operating procedures and monitoring procedures
Review data in the electronic data capture system; enter and reconcile queries as necessary. May also be involved in query resolution. Assist in trend review
Participate in the development of site reference materials
Monitor site preparation, including sending regulatory document packages to sites
Assist the sites in obtaining the required forms and passwords for all electronic systems
Prepare training materials related to monitoring practices and procedures to be presented at monitor training meetings to ensure that the monitors are adequately informed of monitoring requirements and procedures
Review site qualification monitoring visit reports to assess site eligibility to participate in the study
Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions
Track and report on monitoring activities
Assist the CRM in CRO in vendor management, including independently holding meetings to identify and resolve issues. Maintain open lines of communication
Monitor ongoing progress of enrollment and other benchmarks at the investigative sites to assess adherence to the study protocol and timelines
Maintain FIPCUS internal tracking systems, including budgets and expenditures
Mentor CRA’s regarding regulatory accuracy and set-up of the Trial Master File
Mentoring junior CRAs
Ensure that conduct of all studies follow local or global Ferring SOPs and regulatory requirements

153

Clinical Operations Senior Business Consultant Resume Examples & Samples

Facilitate and participate in requirements gathering sessions with clients resources
Document client’s functional requirements for the CTMS or related Clinical Operations systems
Help identify key Clinical Trial Management processes that need enhancement and definition
Facilitate and participate in Joint Application Design sessions with clients to translate their requirements into Functional Design Specifications
Support Perficient development staff as they develop enhancements based on Design Specifications
Prepare System Test documentation based on system Functional Design specifications
Help organize and support execution of System Test of CTMS system
Prepare User Acceptance Testing documentation based on process flow diagrams and user requirements
Help document results and summary for all testing activities
Prepare training documentation and deliver functional training to client resources
Build trusted client relationships through proactive account management and effective project delivery
Establishes knowledge of client business challenges and priorities to translate into opportunities
Maintains regular client communication and satisfaction, ensuring opportunities and challenges are addressed in a timely manner
Translate client’s business needs into detailed business requirements documents, use cases and systems interaction diagrams
Works with customers and internal Creative teams to establish approved wireframes and mock-ups for solutions
Provides leadership throughout the lifecycles of a project, guiding the understanding the project team has through design and development to ensure project requirements are met
Helps establish project test strategy, methodologies, test plans as well as assist with test execution
Oracle’s Siebel CTMS or Pharmaceutical industry / Clinical Trial Management experience
Skilled in system Requirements Gathering and System Design
Project Management experience
3+ years of professional business analysis experience, with strong relationship management, account management, and support experience
Experience working with external clients
Knowledge of Agile and iterative development methodologies
Understanding of current technologies and Software Development Lifecycle (SDLC)
Ability to obtain, understand and respond strategically to client needs
Highly detail oriented, well organized, and able to coordinate multiple projects simultaneously
Strong analytical, problem solving and conflict resolution skills
Energetic, motivated, service-oriented, and be able to multi task
Excellent listening, oral, and written communication skills
Flexible to new situations and challenges
Flexibility to travel up to 50 percent
Some knowledge and exposure to CTMS System Administration or development is a plus
Understanding of complex Internet based enterprise level applications
Track record of delivering on time, on budget, and meeting client commitments

154

Director of Outpatient Clinical Operations Resume Examples & Samples

Bachelor’s Degree required, preferably in a related field
Master’s Degree in business or health care administration required or ability and willingness to achieve within three (3) years of hire into position
Three (3) years of recent demonstrated leadership experience managing multi-specialty groups with 25 or more physicians required
Five (5) years experience working with ACO and Value Based Care Arrangements required
Five (5) years experience with risk contracting required
Five (5) years experience with healthcare strategy work required
Medical Home Certification in Primary Care required
Certification in Practice Management (CPME) through MGMA or AGMA preferred; active in one or both associations
Broad knowledge of physician practices required
Proven ability to formulate and carry out operational plans for physician practices required
Demonstrated knowledge of physician practice financial administration and revenue cycle management for medical offices required
Knowledge of legal issues related to physician practices, employment law and fraud/abuse rules required
Knowledge of project planning and ability to coordinate various projects and activities concurrently required
Demonstrated understanding of healthcare market, delivery systems, and regulatory environment and future trends required
Hires, manages, and provides ongoing performance feedback for Clinic Managers
Collaborates with Clinic Managers and HR on employee relations issues impacting clinic group
Ensures approved policies, procedures and other Hospital and Health Care initiatives are implemented appropriately and consistently throughout Primary Care Practices
Represents assigned practice(s) at operational leadership meetings. Provides SHMG Leadership with updates on operations, performance targets, and insures adherence to regulatory compliance (e.g. Joint Commission, CMS and HIPAA) to SHMG standards
Collaborates with providers to encourage individual provider success as well as the success of the Primary Care practice
Successfully coach and lead staff through Kaizen initiatives, acting as mentor. Stays up to date on all Kaizen requirements, and engages front line staff as appropriate

155

Director of Clinical Operations Resume Examples & Samples

Plans, implements, evaluates, coordinates, and directs therapeutic programming and treatment planning for behavioral health service line on a 24 hour basis in accordance with recognized and accepted internal (e.g. unit, department, and hospital) and external (e.g. TJC, Medicare, OSHA) standards in order to facilitate optimum care and health education for patients, and appropriate utilization of resources
Administers fiscal operations, monitoring financial performance, authorizing expenditures and coordinating financial reporting
Develops and implements policies and procedures, and assures understanding and compliance by personnel. Interprets policies and procedures to physicians, patients and visitors
Prepares reports to inform management of progress, needs or problems associated with provided services
Consults with other department heads, physicians, community groups to promote MHS behavioral health services, and to see that provided services are responsive to the needs of patients, physicians and community
Manages personnel to include interviewing, work allocation, orientation and training, staff development, problem resolution, evaluating performance, making recommendations for personnel actions, and motivating employees to achieve peak performance. Is responsible for their employee’s output and conduct

156

Associate Analyst, Clinical Operations Resume Examples & Samples

Identify, develop, recommend, and implement basic process development and process improvement solutions to optimize global trial workflow timelines, (e.g., query resolution, open information requests, aging issues, status of image analysis from Core Labs to study database, etc.) with guidance from Core Lab Manager
Identify critical elements and organize data from internal and external sources and analyze clinical output of basic studies
Develop basic criteria of workflow timeline assessment from clinical site through Image workflow vendor to Independent Core Lab, in collaboration with clinical stakeholders
Communicate study trial status from Core Lab image perspective, including issues and successes to clinical stakeholders and all levels of management
Facilitate training sessions for site personnel and/or Edwards personnel, based on technical content provided by the Core Lab Manager
Other incidental duties assigned by Leadership
Bachelor's Degree in related bio/health sciences field required
1 year of previous hands-on clinical research related experience required; preferably in Cardiovascular and/or Medical Device
Good computer skills in usage of MS Office Suite including Excel required
Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
Basic knowledge of human anatomy and physiology
Good problem-solving, organizational, analytical and critical thinking skills

157

Clinical Operations Specialist Resume Examples & Samples

Oversee the analysis and redesign of operational processes to improve efficiency and effectiveness. Measure and evaluate operational effectiveness; compare measurement results to standards and work with the team to improve performance and close identified gaps.Uses metrics and data to lead process improvement initiatives.Analyzes and queries data
Research and identify industry best practices to achieve optimal operational outcomes.Develop and maintain reporting metrics for the department as well as documentation necessary to support consistent, operationally sound processes:tip sheets, standard operating procedures, audit tools.Maintain the department WIKI
Job performance requires fulfilling other incidental or related duties as assigned such as KPI and Incentive reporting, and performing duties of higher rated positions from time to time for developmental purposes
Proficiency with Excel, Facets, WebFocus & Confluence preferred
BA/BS required
MA/MS – Masters Degree preferred

158

Clinical Operations Coordinator Resume Examples & Samples

Manages the monitoring, auditing and reporting requirements related to monthly, quarterly and annual regulatory and compliance requirements. (30%)
Manages special needs plan regulatory requirements related to health risk assessments, model of care
Responsible for the management of the 5 Star program quality and customer service measures initiatives
Participates in quality management activities. Assists with quality audits, preparing documentation, reports, obtaining data, and supporting on-site audit initiatives. (25%)
Knowledge of health care and insurance industries and health care delivery systems
Honed interpersonal skills to interface with community members of the healthcare team, health plan clinical staff, and health plan leadership team
Computer skills for documentation purposes, and ability to use a variety of software (database and spreadsheet) applications to maintain records, analyze alternatives, evaluate trends, and to assist in problem-solving and decision-making responsibilities
Data analytics capabilities to identify opportunity areas for quality improvement programs relative to the 5 Star initiatives
Analytical skills to evaluate problems and recommend alternative solutions

159

VP Hedis Medical Clinical Operations Resume Examples & Samples

Set, plan and execute annual HEDIS strategy
Works closely with the leaders of United’s Healthcare’s LOBs to align and deploy strategies for successful HEDIS collection and reporting
Direct management oversight for business process initiatives that optimize quality and efficiency in support of organization HEDIS objectives
Focus on inter-segment coordination and cooperation to ensure timely and effective decision making on key issues
Serve as liaison for the HEDIS business areas, providing assistance and direction for business processes to ensure timelines and desired business outcomes are realized
Act as a key resource to SVP, Population Health, UnitedHealthcare Clinical Services in identification and development of HEDIS operational improvements, strategic planning and projects
Develop HEDIS organizational structure and resource allocation to assure the most efficient and successful HEDIS operational results
Manages and evaluates projects progress and results to determine improvements required to meet ultimate operational, financial and timeline targets
Builds and maintains alliances with customers, business partners, consultants, providers to meet/exceed business objectives
Successfully recruits and develops staff to continuously improve their overall effectiveness and engagement
Serves as Untied Healthcare’s HEDIS SME
Provides leadership and is accountable for the performance and results of the diverse and broad functions in HEDIS operations by managing the span of control within HEDIS Operations
Serve as HEDIS Operations representative on critical committees
Serve as representative, as needed, for external activities related to HEDIS-example NCQA quarterly meetings
Responsible for building adequate resources within HEDIS Operations who are accountable for determining, operating and maintaining appropriate HEDIS reporting and operating systems
BS/BA in business related field; Masters degree required
10-20 years’ experience in leading a significant and diverse functional operation, experience in a compatible industry (i.e. healthcare industry) strongly preferred
10+ years of significant leadership and managerial experience
10+ years’ experience, with demonstrated functional knowledge, process improvement initiatives, and organizational behavior
5+ years of experience with technical data analysis and reporting
5+ years’ experience and knowledge of quality process audit readiness
5+ years working knowledge of NCQA’s HEDIS Technical Specification
Demonstrated competency and success in building and sustaining relationships with internal and external stakeholders in a high pressure environment
Excellent written and oral communication skills with internal and external business partners and employees
Strong independent decision maker and risk taker
Proven success in improved performance leading a large functionally aligned business segment/area

160

Manager, Medical & Clinical Operations Resume Examples & Samples

Sets team direction, resolves problems and provides guidance to members of own team
Monitors, manages and controls operational and performance metrics in conjunction with established program value targets
Missouri-licensed Mental Health Clinical Nurse Specialist, Mental Health Nurse Practitioner, OR a Missouri licensed Psychologist/PH.D. License must be current and unrestricted
3+ years of hands-on clinical experience
2+ years of Case Management experience
CCM, current or willing to obtain within 24 months of employment
Proficient in Microsoft Excel, Word, PowerPoint and Outlook
Reside in the state of Missouri
Ability to travel to Kansas City, MO up to 25% of the time
Managed Care/Insurance experience
Experience managing a virtual and/or field-based team
Demonstrated ability with developing strategic plans, attainable goals, drive performance, and achieve targets
Ability to work in a rapidly changing environment being adaptable and flexible

161

Clinical Operations Supervisor Resume Examples & Samples

Responsible for the coordination and quality of care of patients in Convenient Care
Participate in the interview, selection, orientation and development of clinical staff
Supervise / evaluate clinical staff for compliance with all Southwest Medical and UHG policies and procedures, state and federal regulations, and standards of practice
Ensure and participate in the development and implementation of patient centered care plans
Ensure communication and coordination of patient care needs to primary care team
Accountable for completion of referral process
Participates in community outreach programs
Participates in employee community council
Support and implements new processes, supporting clinic and business initiatives
Identifies and develops education / orientation plan for staff
Conduct and engage lean standards & audits in workflow
Manage patient concerns for improved experience
Knowledge of and experience in responding to regulatory standards
Knowledge of best practices in customer service and patient care
Demonstrated organizational, strong leadership and team building skills
Provides direct patient care (if licensed clinician)
CPR Certificate or willing to possess within 30 days of hire
3+ years experience in a healthcare organization, preferably in an Urgent Care setting
3+ years experience utilizing EMR
Previous accountability / oversight of referral processing
Ability to navigate MS Office and a Windows based environment and the ability to create, edit, save, and send documents utilizing Microsoft Word and Excel. Ability to navigate Outlook and conduct Internet searches
3+ years progressive Supervisory or Management experience, within a healthcare setting
LPN with a current, unrestricted Nevada LPN license or temporary Nevada LPN license with the ability to obtain permanent Nevada LPN license upon expiration of temporary Nevada LPN license

162

Clinical Operations Intern Resume Examples & Samples

Assist in the tracking and archiving of documentation associated with the conduct of investigational clinical studies
Support the Clinical Operations team in reporting project metrics and status updates
Participate in the clinical study team meetings and report on status of assigned tasks
Review and comment on essential documents associated with clinical trials
The individual will learn the phases of drug development and the associated current good clinical practice requirements (cGCP) and International Conference on Harmonisation (ICH) guidelines. The individual will also have the opportunity to review and understand the content of various documents that are developed in conjunction with a clinical study. They will have the opportunity to learn about the different types of regulatory filings in support of clinical research
Requirements

163

Clinical Operations Resume Examples & Samples

Oversees and directs management of all area clinical operations
Reviews monthly department and individual therapist outcomes and supports staff in identifying strategies to improve outcomes as needed
Takes responsibility for the development and support of all staff in their Area to include rounding, second- tier rounding, coaching and mentoring
Reviews strategic plans with senior management to achieve the goals of Genesis Rehab Services, and ensures that policies and procedures of the company are consistently followed
Conducts Director of Rehab meetings on a regular basis to communicate, develop and remove barriers to patient care and increase customer satisfaction
Assumes responsibility for marketing the services of Genesis Rehab Services within the assigned area in conjunction with Business Development
Accepts responsibility for meeting budgetary goals and financial P-L for the assigned area
Meets clinical education needs of their Area
Assures compliance (CI - Quality) in their Area
Assumes responsibility for and participates in Area corporate integrity investigations and quality audits in conjunction with the compliance department and other departments as necessary
Ensures appropriate levels of staff to meet patient and customer needs. Ensures that customer expectations are being met and monitors satisfaction levels; creates monthly reports for customers and schedules quarterly in-person meetings
Assures new contracts are initiated according to GRS standards in conjunction with Business Development
Acts as a resource to the Director of Rehab for the performance appraisal and clinical performance management of staff
Oversight of the operations of student placements

164

Global Clinical Operations Portfolio Manager Resume Examples & Samples

Provide effective and efficient project management of the GCO clinical study portfolio and the governance that oversees these clinical studies (Clinical Operational Review & Execution, CORE)
A core member of the CCPS Leadership Team, the GCO Portfolio Manager
Provides effective and efficient project management of the GCO clinical study portfolio and the governance that oversees these clinical studies (Clinical Operational Review & Execution, CORE)
Within CORE, drives cross-therapeutic area collaboration to ensure appropriate level of prioritization and alignment across clinical programs
Utilizes a variety of project management tools to sustain high-performing GCO cross-functional performance
Coordinates quarterly GCO Operational Priorities and Key Deliverables memo
Monitors progress of the GCO portfolio towards GCO and R&D goals; report progress through GCO scorecard
Represents GCO ELT in the study starts functional approvals
Liaises between Resource & Operational Management (BIA) and GCO ELT in resource planning in support of the GCO portfolio
Coordinates book of work planning across all phases of GCO clinical studies
Ensures timely project-level reviews at CORE through collaborations with OPLs/Lead Protocol Managers and Planning & Execution Leads
Communicates changes to study timelines and project status or risk
Leverages R&D Analytics reporting to inform proactive planning and ongoing recruitment
Liaises with ODC, SDC, and EDC governance support team leads in appropriate escalation of GCO issues & risks
No direct managerial responsibility but Influencing skills (to peers and upward to management) are necessary to perform this role effectively
Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and or addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate solutions
Demonstrated leadership skills; successfully managed large project teams. Has conducted and implemented team success through articulation of goals using power of persuasion, promotion and relating to peoples, needs
Knowledge of clinical research - Understands the drug development process across all phases of clinical development. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project
Demonstrates strong written and verbal communication skills. Ability to conduct effective presentations
Working knowledge of MS Office suite and MS Project or equivalent. E-plan, ECLIPSE, Spotfire/tableau experience desirable6. Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
Bachelor’s degree required, advance degree preferred (MS, MBA, PhD, PharmD or other advanced degree in a physical or natural science) with 7 or more years’ experience in the pharmaceutical industry in areas such as biology, clinical development, pharmaceutical development, or chemistry
Development project management experience is required

165

Clinical Operations Specialist Resume Examples & Samples

Study budget management. Responsible for evaluation of investigators fees (country level budget/Grant Plan) estimates per country and the negotiation of investigators fees and country related study costs. Support Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget
Vendor and monitoring partner coordination. Support CPM in the set-up and coordination of third-party vendors (i.e. central lab, investigators’ meeting organization) and monitoring partner, ensuring all information, docu-mentation and material in place for study start. Responsible for effective and smooth workflow between study participants (i.e. third-party vendors and monitoring partner). Follow-up with vendors and monitoring partners on day to day operations (recruitment reports, delivery of study kits …)
Study logistics. Responsible for the set-up and maintenance of studies in Clinical Trial Management Systems (CTMS). Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF). Ensure availability of study material for monitoring partner/sites (i.e. IV bags, fridge, laptops, etc…) including tracking of rented material. Support CPM in keeping overview of drug availability at site level in collaboration with monitoring partner and drug supply management. Support CPM in meeting set-up, minutes, running reports from systems, draft study documentation. Support CPM in study start up, recruitment and close out activities as required
Strong technical and organizational skills (Excel, MP,), Details oriented
Willingness to act accountably in project/study management

166

Manager Medical Clinical Operations Resume Examples & Samples

Manage clinical operations across the continuum of care to include assessing, planning, implementing, coordinating, monitoring and evaluating health care delivery
Provide monitoring and oversight of care management and coordination of care for our members
Serve as a coach, mentor and advocate for staff in their development and training
Conduct team meetings, caseload auditing and implement performance improvement plans
Current, unrestricted RN license in the state of New Jersey
Minimum of 5 years care management / care coordination experience within a medical, corporate or behavioral healthcare setting
5+ years of Clinical background
Proven experience resolving member and provider issues
3 years previous leadership experience with the ability to partner with staff to build high-performing teams
Experience and understanding the root cause of complex issues
Excellent organization, communication, teambuilding and time management skill
Ability to proactively partner with care team, including primary care, behavioral health, state partners and other key stakeholders
Care Management experience
Certified Care Manager (CCM)

167

Global Clinical Operations Lead Americas Resume Examples & Samples

Manage, coach and develop clinical project managers and CRAs"
Manage Clinical Operations resources and budget. Supervise internal and/or contract clinical operations resources, and oversee/manage clinical vendors, including CROs
Bachelors degree required (PhD preferred)
15+ years of clinical trial management and operations experience in the pharmaceutical or biotech industry in North America or more broadly Americas
Ability to motivate and inspire people to share the vision
At ease in both a matrix and hierarchical environment
Ability to think outside the box
Ability to challenge the status quo
Passion for Innovation and Renovation
Flexible to ever-changing priorities internally and externally
Adaptable to objectives shifting during the project
Hands-on - be involved
Strong Leader but also a collaborator

168

Clinical Operations Specialist Resume Examples & Samples

Five (5) years of experience in delivery and administration of correctional medical
Five (5) years administrative, management and supervisory experience in correctional nursing
Experience in understanding and managing budgets and analyzing contracts
Monitors the implementation and effectiveness of procedures and programs throughout the company
Evaluates statistical data, programing needs and problems throughout the company, assists in planning of the nursing orientation, nurse in-service training, and continuing education within the company, program needs and makes recommendations for improvements
Evaluates and recommends methods of improving operational efficiency and cost effectiveness
Completes and submits daily, weekly, monthly and annual reports in a timely and accurate manner
Assists in monitoring all sentinel events and potential catastrophic illnesses and explores/utilizes all appropriate means of limiting both CCS and contractor's liabilities
Meets with designated wardens, deputy wardens, and facility administration on a regularly scheduled basis and serve as backup to H.S.A.s to participate in MAC/QI/P&T and other required meetings as needed
Identify problem areas of operations and propose solutions. Conducts ongoing evaluation of services and health care programs, proactively identifies potential problems and assists in developing corrective action plans
Attends seminars, workshops, and conferences
Must be able to travel overnight for two to ten days or more as may be required by division/region needs
Post Orders, if applicable, per site contract
Must be able to apply principles of critical thinking to a variety of practical and emergent situations and accurately follow standardized procedures that may call for deviations

169

VP of Clinical Operations & Medical Management Resume Examples & Samples

Clinical Operations: Utilization Management, Case Management, Disease Management for all Commercial lines of business, Medicare, and FEP
Medical Directors: MD team supports Clinical Operations and the Appeals & Grievance team in Customer Experience
Provider Dispute Resolution: highly regulated dispute function
Medical Policy: implementation and management
Enhanced Clinical Program: part of Medical Policy. Team built to identify, create and implement programs that deliver high value to our members and high value to BSC. Examples include: genetics program, hip/knee program (only one of its kind in the NATION), home sleep study program
Payment Policy: implementation and management, includes clinical code editing solution (ClaimsXten)
Clinical Program Management: oversight and management of strategic partner programs (e.g. Nurse 24/7, Disease Management, Life Referrals, Advanced Imaging, etc.)
Training & Support: training, auditing, coaching of MCS staff, inclusive of engagement and relational coordination interventions and support across entire division
Provider Communication & Education
Medical Operations Analytics: operational reporting and analytics
Medical Solutions & Support: team of process engineers, developers, and analysts responsible for delivering process improvements/re-engineering and solutions for MCS operations. Management and configuration of the UM and CM systems. Provides consultation and facilitation of strategic planning sessions across the division, including Markets
Managing large teams in multiple locations
Blues experience
Training in CPI: Lean or Black Belt Training (Six Sigma)

170

Director of Finance & Clinical Operations Resume Examples & Samples

Demonstrated leadership and supervisory, planning and change management skills
Excellent communication skills. Able to influence people, solve problems, troubleshoot, think creatively and resolve conflicts
Advanced expertise in grants and contract administration
Advanced analytical and problem solving skills Strong knowledge of industry standards and/or regulatory requirements
Advanced expertise in business and management computer applications and databases
Advanced degree in Business Administration or related field preferred
Experience in a clinical department at an academic medical center desired
Ability to perform business analysis to determine best use of resources to complete complex tasks and projects; must be able to work effectively in a fast-paced, and sometimes ambiguous environment with changing priorities
Expert-level skills in Microsoft Excel

171

Clinical Operations Production Supervisor Assistant Resume Examples & Samples

Technical leadership of the employees in the production
Issue of production release
Support for start-up and training of employees
Monitoring of ongoing production
Control of the production data acquisition
Training of employees
Monitoring compliance with the production plan
Monitoring compliance with work instructions
Processing of deviations, complaints and corrections in the production area
Review of batch documentation
Creation and revision of SOPs

172

Manager, Medical Clinical Operations Delaware Resume Examples & Samples

Participates in supervised field visits with the Community Health Workers
Ensures audits are conducted timely, standards are met, and successful outcomes are achieved
Ensures site remains compliant with all applicable regulatory and accreditation requirements (NCQA and URAC)
Collaborates across Optum and UHG and interacts with Medical Directors, Site Directors, Senior Leaders, Network, Marketing, Account Management, Quality, Product, and other stakeholders
Minimum of 1 year of Case Management experience
Must reside within the state of Delaware to participate in supervised visits with direct reports
BSN with unrestricted RN license in the state of DE
MSW with unrestricted LMSW / LCSW license in the state of DE
Master’s Degree in Healthcare or related field
Experience with data analysis
Experience with training and coaching
Prior supervisory or management experience (including performance management functions i.e. hiring, performance evaluations, corrective action plans, etc.)
Experience working with the Medicaid and Medicare population
Experience with accreditation requirements (NCQA and URAC)

173

Senior Specialist Clinical Operations Resume Examples & Samples

Developing, planning and managing the TMF process and associated infrastructure, including contract resources
Supervising the study TMF set-up; organizing and leading the TMF kick-off meeting with key representatives from the Clinical Team. Based on the specific organization of the trial, evaluating the risks with regards to the TMF
Managing the Clinical Research SOP life-cycle, infrastructure and associated department training requirements
Providing direction to the Clinical Documentation Coordinators and Contract Research Organizations (CROs) in the processing of the TMF documents in order to ensure document quality, proper indexing/ filing and real-time management of documents submitted to the TMF
Organizing and performing TMF Readiness checks at key study milestones. Proposing and leading any corrective action plans
Reporting study TMF progress and issues to the Clinical Team and the Operations Manager in charge of the program
Participating in the preparation of the audit or FDA inspections. Coordinating the clinical documentation responses to questions or observations
A Bachelor's Degree in a related discipline, advanced degree preferred
A minimum of 2 years of experience in clinical trials in the tobacco industry. Experience with clinical research document control ALCOA requirements (Attributable, Legible, Contemporaneous, Original and Accurate)
Knowledge of FDA tobacco product applications / regulations, ICH guidelines and GCP practices
Excellent communication and presentation skills; attention to details; ability to think pro-actively and to escalate concerns and issues in a timely manner
Ability to comply with project or task timelines to support overall success in project milestones
Ability to independently apply basic scientific principles, problem solving and time management skills in completing assigned tasks
Proficiency in Microsoft office products and professional writing skills
Understanding of regulatory document review. Overall willingness to learn the tobacco industry and the growth of regulations relating to clinical research
Ability to accommodate 10-20% travel

174

Supervisor Clinical Operations for Wellmed Resume Examples & Samples

Directs, supervises, coordinates specific functions and activities of clinic, including systems, policies and procedures, human resources, support services, etc. required
Reviews operational problems/policies and recommends solutions and change to Medical Director
Recommends funding based on knowledge of policies, costs, and operating practices
Bachelor degree in health or business administration required. (4 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor’s degree)
Three or more years of healthcare administration experience required, including one year of supervisory experience
Knowledge of health care administration, clinic philosophy and policies and operating procedures required
Knowledge of fiscal management systems required
Knowledge of human resource management practices including supervision and staff development required
Knowledge of governmental regulations and reimbursement standards required
Knowledge of computer programs and applications required
Skill in exercising initiative, judgment, problem solving, decision making required
Skill in developing and maintaining effective relationship with staff, Senior Management, patients, vendors, payers, public required
Skill in organizing work to achieve clinic goals and objectives required
Ability to research and prepare comprehensive reports required
Ability to monitor compliance standards required
Current unrestricted Vocational Nurse license for applicable state of employment

175

Global Clinical Operations Lead Resume Examples & Samples

Build and lead a high performing Clinical Operations team to drive complex clinical trials with regulatory and drug development pathways, creating solid infrastructure to bring elements of Clinical Operations in-house
Manage, coach and develop clinical project managers and CRAs
Manage and oversee high complex or high risk end-to-end clinical trials and broad knowledge in operations, drug development, R&D and business
Lead the development and adaptation of new clinical trial platforms and operations in support of drug development; keeping current with regulatory guidance and requirements in the global environment; ensure data integrity of deliverables; provide sound clinical, scientific and operational input to meet project objectives and regulatory data requirements for all clinical trials
Utilizes highly developed project management skills to lead and co-ordinate all clinical trial activities from study protocol to the delivery of clinical study report, according to the agreed baseline timeline for all clinical trials
Provide clinical operations representation and leadership in the area of clinical trial design and analysis, including protocol development, Statistical Analysis Plan (SAP) and clinical study report (CSR); Participate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publication
Oversees all clinical contracts to provide timely and accurate input into financial management systems based upon agreed clinical project budgets
Takes transversal responsibility for major and complex assignments with high impact beyond the Clinical Operations scope
Bachelor’s degree required (PhD preferred)
Minimum of 8+ years of direct management experience of clinical professionals with increasing levels and/or breadth of responsibility
Clinical experience, for example, any health care professional qualification
Courage to challenge stakeholders as well as team members for the best results
Ability to think outside the box and positive attitude

176

Senior Consultant, Clinical Operations Resume Examples & Samples

Achieve and maintain advanced knowledge of Cardinal Health Skin, Wound, and Incontinence products
Provide Phone, email, and in-person training and clinical support to clinicians and Cardinal Health employees
Provide initial and ongoing clinical training for sales and other team members

177

VP, Clinical Operations Resume Examples & Samples

BS required, advanced degree with scientific or health-care training preferred and minimum of 15 years’ bio/pharmaceutical development experience in clinical trial operations, with a minimum of 10 years leadership experience
Experience in drug development with expertise in clinical trial conduct from Phase 1 through Phase 3 including IND and NDA/BLA/MAA
Experience in strategic planning of clinical trials
Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication
Experience developing, implementing and leading a broad range of global clinical trials, building infrastructure to support clinical trials, including policies and procedures for a growing organization
Experience with Clinical Operations line management, and mentoring and developing personnel
Extensive experience managing contracts (vendor and site) and clinical finance activities
Excellent working knowledge of FDA, EMA & ICH/GCP regulations and guidelines
Ability to work in a team environment, meet deadlines, and prioritize and balance workloads of a department
Ability to motivate individuals and teams
Detail oriented and ability to creatively problem solve
Willingness and ability to travel domestically and internationally as required

178

Head Global Clinical Operations Resume Examples & Samples

Build strong relationships with Regional Therapeutic Area Experts, GCO Early Development & Clinical Pharmacology, and GCO Medical Affairs regional leadership, Local R&D Heads of other countries in region, Clinical Trial Coordination leadership, Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance and external vendors locally
Contributes to shaping an attractive clinical trials environment through active involvement with Pharma Industry Associations, Medicines Agencies, Health Authorities in local country
Ensures the site selection processes are in alignment with business and country strategic goals
Leads metrics review in country, and ensures necessary follow-up actions
Contributes to design, development and evaluation of the Clinical Operations processes and standards to improve clinical trial management. Ensures rollout of new procedures in country
Maintenance of the contracts with the Safety Unit as appropriate, and ensures the Study Overview Table is provided to the Local Safety Officer (LSO)
Evaluates and projects overall resource needs for , and requests resources as appropriate
Strong interaction with Flex Resource managers to ensure qualified staff is obtained in timely manner and to provide feedback on Flex Resource performance. Works with Flex Resource managers to on-board and off- board staff
Interviews, hires, develops and trains staff
For employees: Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D
Ensures adequate, timely and compliant management of clinical studies through all phases of the trial- Feasibility through Database lock by assigned TCSM staff
Ensures studies are in a constant state of inspection-readiness. Work with Quality and Compliance (QC) liaisons to ensure quality oversight of studies utilizing the available tools
Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO
Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation
Communicates with staff on program changes, policy changes and priority shifts
Conducts Accompanied Site Visits with Site Managers
Review and approve expenses; assure expenses are in compliance with the company’s policies
Strongly Demonstrates Leadership Behaviors in alignment with Leadership Imperatives
Provides mentorship as needed (outside of direct reports)
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years’ experience in the pharmaceutical industry, at a CRO or hospital including extensive clinical research experience. Experience working within (country/region) clinical trial market is required
Excellent communication and leadership skills and proven ability to foster team productivity and cohesiveness
Demonstrated expertise in mentoring/coaching others. Proven track record of people management and talent development. Ability to lead hiring, training, development and evaluation of people. Strong decision-making and financial management skills
Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations. Strong ability to synthesize and evaluate data generated from various reports and sources
Demonstrated skills in interfacing with various internal and external (e.g. hospital boards, agencies, ethics committees, health authorities, etc.) stakeholders. Experience working with CRO partnerships is desired Operates with limited supervision
Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.1700176067W

179

Clinical Operations Supervisor Resume Examples & Samples

Competent in BLS and/or other specialized life support requirements designated by work area
Good working knowledge of CMA and Radiology Technologist responsibilities and understanding of clinic flow
Ability to effectively lead teams and establish and maintain effective relationships with other personnel
Knowledge and ability to apply situational leadership skills
Ability to create and apply specific departmental policies; Joint Commission standards
CMA- 8
Rad Tech - 2

180

Senior Mgr, Clinical Operations Resume Examples & Samples

Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum
Minimum 5 years of experience in the pharmaceutical industry in the pharmaceutical industry in a position performing clinical operations functions
Experience working on large, global studies with multiple vendors involving management of submission timelines and associated processes
Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required
Solid project and vendor management, analytical and problem solving skills
Prior experience with development and tracking of study budgets in excess of $20M
CNS experience preferred but not required

181

Clinical Operations Specialist Resume Examples & Samples

Ability to work effectively with colleagues in an environment that promotes innovation, teaching, learning, and service to a diverse student population
Ability to communicate effectively both orally and in writing with colleagues, vendors, students, administrators, and public stakeholders
Ability to mentor students from diverse backgrounds who have a wide range of skills, motivations, preparation, and academic and career goals
Skill and ability to participate with faculty in curriculum development delivered by various modalities
Knowledge of program planning review and assessment processes in a higher education setting
Ability to contribute to the development and assessment of student learning outcomes (SLOs) and program outcomes (POs)
Knowledge of college pathways and articulation processes
Ability to participate in recruitment and articulation activities with local schools, colleges, and universities
Ability to maintain technical currency and knowledge of clinical situations as described in case studies
Ability to utilize technology in the delivery of skills-based instruction
Skills and ability to explore new technologies for instruction and learning
Ability to diagnose, manage, and troubleshoot faults in simulation and audio/video technology
Ability to work independently with minimal supervision and to work effective as part of a team
Knowledge of proper body mechanics, ability to lift up to 40 pounds and to complete repetitive movements
1) Resume

182

AVP, Clinical Operations Resume Examples & Samples

Bachelor Degree in Nursing required. Master's degree in Nursing or related field
At least three (3) years of work experience or equivalent in a CNO role
Valid Nursing license
Evidence of active participation in continuing education in Nursing Executive Management and Health Care Administration

183

VP, Clinical Operations Resume Examples & Samples

Advanced degree in business administration, business development, marketing or health care related field
A minimum of 5 years recent executive leadership in a service oriented, customer centric, retail environment. The ideal candidate must demonstrate multi-year leadership responsibility and delivery of successful metric in a growing, complex and successful ventures
Understanding of the health care delivery environment a plus
Demonstrated leadership and operational responsibility in a large/complex customer oriented service and retail environment
Demonstrated success in collaborating with other key providers. Understanding of physicians and physician environments a potential advantage
Demonstrated excellent in customer service and customer satisfaction and the ability to maintain high Associate engagement and satisfaction
Ability to successfully apply new learning to achieve expected outcomes
Demonstrated excellence in negotiation, facilitation, influencing and collaboration skills
Demonstrated understanding of financial operations and ability to meet/exceed financial expectation on an ongoing basis

184

Clinical Operations Director Resume Examples & Samples

Operations leader with a business or clinical background
Demonstrated success in change leadership in large organizations
Proficiency in analyzing and interpreting financial and other business performance trends and creating plans to evolve the business
Demonstrated experience with continuous performance improvement practices
Able to travel up to 25% - business primarily on east coast

185

VP Clinical Operations Resume Examples & Samples

Implements clinical strategy for total population health
Proven ability to lead and manage a large staff, including clinicians through enablement, positivity and optimism
At least 10 years of managed care experience with the majority in care management and/or utilization management
Understanding of medical cost drivers with proven ability to leverage savings opportunities effectively
Knowledge and experience in utilizing technology to Drive for results
Demonstrated ability to build impact and influence through cross-group collaboration and execute on a vision for strategic change
Proven customer focus
RN, licensed in Connecticut
Masters’ degree in Nursing, healthcare, or business, or an equivalent combination of education and experience
Excellent decision making ability, communication and interpersonal skills

186

VP, Clinical Operations Resume Examples & Samples

Strategic oversight of the design and execution of clinical trials for BIPI; Contribute to design development and ensure the quality and execution of BIPI Clinical Trials in conjunction with local (CDMA) and Corporate Clinical Development across multiple established therapeutic areas (e.g., Respiratory, Oncology, Metabolic, Cardiovascular, Virology, Immunology) in addition to proof of concept for new compounds and indications; resource/budget and planning of BIPI contributions for project/ trial execution across Clinical Operations in support of business objectives
Ensure adherence to/compliance with departmental SOPs and Company policies, national and international regulatory and legal framework including ethical, medical and scientific standards regarding Clinical Development Operations
Develop and ensure continuous improvement within Clinical Operations regarding structured work processes and quality improvement initiatives. Integrate best practices around new technologies to increase efficiency in capturing and reporting clinical trial data
Develop, implement and govern strategic operational goals and guidelines within and across Clinical Operations Functional groups (CFO, CSIM CTM and Business Group) and align those goals with cross functional partners (BDM, QMMR and DRA) locally and globally in collaboration with Global head of Clinical Operations, Biometrics and Data Management
Creates a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge, process and procedures. Set job expectations, provide regular feedback, conduct timely Max Plan reviews, identify performance challenges, create action plans and monitor the effectiveness of those action plans. Complete Career Planning and competency assessment to ensure professional development of department members
Resource management and creation/ implement of strategies within Clinical Operations in collaboration with cross functional partners to ensure adequate preparation and support of audits (internal and external) and inspections (Sponsor/ site); ensure quality, compliance and successful Regulatory applications globally
Develop and govern processes for cross functional collaboration (DRA, QMMR, CDMA and BDM) to include processes, communications plans and defined accountabilities for roles and responsibilities to ensure Clinical Operations deliverables, quality compliance and data integrity in keeping with business objectives
Regularly contribute operational and medical expertise (MD) and data to internal (e.g., peers, direct reports, superiors, cross functional leadership) and external partners (e.g., Investigators, site personnel, PhrMA, Regulatory Agencies) to ensure quality, compliance, data integrity and business objectives
Training, education and supervision of employees and staff regarding all aspects of clinical research and medical expertise to create high competency and quality according to the requirements of clinical operations regulations (GCP/ICH) and medical/therapeutic area expertise
Support and initiate activities to address talent and performance management and personnel development within the framework of the BIPI and global organization

187

Clinical Operations Supervisor, Davita Rx Resume Examples & Samples

Minimum of 4 years’ experience in pharmacy, health care and/or insurance industries
Minimum of 2 years’ supervisory experience over teams of 10 or more
Intermediate computer skills and proficiency in MS Word, PowerPoint, and Outlook
Ability to analyze data and make data-based leadership decisions for improved team metrics
Demonstrated flexibility and ability to adapt easily to a fast-paced, changing environment and to follow through on tasks and assignments
Ability to meet deadlines and to adjust priorities appropriately in an evolving work environment with shifting time frames

188

Clinical Operations Analyst Resume Examples & Samples

Demonstrable aptitude/willingness to learn data analysis or reporting, application or technical support and problem solving, end-user training and customer service, healthcare specific workflows
Experience or education in clinical or process improvement
Demonstrated analytic and problem solving skills
Strong problem solving, logical reasoning, customer service and training skills
Professionalism and self-motivation
Candidates should have a passion for improving systems and processes and desire for real responsibility
Willingness for continuing education and development in process improvement methodologies
Experience with conducting continuous improvement training
Understanding of and experience in project management
Previous Clinical IT or Informatics experience

189

Clinical Operations Head Resume Examples & Samples

8+ years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development, in a multidisciplinary environment and with demonstrated managerial experience
Excellent knowledge of GCP
Superior leadership skills wth demonstrated ability to build and maintain highly efficient teams in complex environments
Superior communication and relationship skills
In depth knowledge of drug development process; preferably of vaccines development
Superior analytical skills and ability to think / frame problems strategically
Independant and pro-active individual able to implement adequate responses to situations without guidance; self motivated and able to motivate and guide others
Able to work in ambiguous circumstances and take actions quickly while involving the right stakeholders in the right situation at the right time
Ensuring strategic local input is provided at early stages of clinical development
Ensuring compliance with the local operating environment including compliance to regulatory requirements, GCP and GSK standards
Ensuring robustness of the local delivery results
Ensuring an adequate network of clinical sites is in place to support local and global development needs
Lead, coach, mentor and develop the local/functional clinical operations team
Represent LOC clinical operations in global/local internal and external forums

190

Clinical Operations Program Director Resume Examples & Samples

A bachelor’s degree in business, business administration, finance, accounting, healthcare administration, public administration, information systems, or a directly related field from an accredited institution
The ideal candidate will possess at least 4 of the following 6 preferred qualifications
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
Operational understanding of health professions education in an academic setting, including its diverse constituents and complex organizational structures
Understanding of nurse-led care models and scope of practice of advanced practice nurses
Strong financial management and organizational skills
Excellent problem solving and negotiation skills
Strong computer skills, including the ability to work with a variety of applications
Ability to creatively evaluate, analyze, and interpret vast amounts of data in order to recommend solutions and implement a preferred course of action
Ability to set objectives, establish priorities and follow initiatives through to fruition

191

Clinical Operations Coordinator Resume Examples & Samples

Participates in Bi-Yearly Resolutions process with the Board of Nursing and AZ Hospital Administrators to negotiate and obtain clinical spaces for each GCU pre-licensure student
Acts as University direct contact to create and maintain partnerships with AZ Hospital Administrators and community agencies to meet clinical placement needs
Finalizes clinical schedules and communicates with faculty services to build approved rotations for faculty scheduling
Populates and maintains the myClinicalExchange(mCE) system for all approved clinical rotations, clinical faculty and students within the program
Ensures all clinical sites are approved and put into scheduling database for assignment
Works closely with the Office of Field Experience to ensure clinical rotations are being scheduled appropriately for students within the program
Works closely with the Office of Field Experience to ensure all students are meeting agency deadlines for compliance
Acts as University direct contact with AZ Hospital Administrators and completes/delivers all Clinical Experience Requirements Forms (CERF’s) to each clinical site by state approved deadlines
Coordinates and oversees clinical field placement rotations and takes steps to streamline and improve processes where needed
Serves as the focal resource person for faculty and students in any matters relating to the clinical rotations
Perform related duties as assigned and needed
Bachelor’s degree in Nursing from a CCNE/NLNAC or ACEN accredited program
Must have active unencumbered RN license
Broad knowledge and understanding of all specialties in nursing patient care practice
Highly knowledgeable of nursing processes and procedures as related to patient care
Proficient with computer software including MS Office Suite
Master’s Degree (MSN)
Work experience which involved administrative or coordination of activities related to accreditation, licensing and regulations

192

Clinical Operations Lead Resume Examples & Samples

Candidate must have a minimum of a BA or BS Degree with a minimum of 10 yrs. of pharmaceutical experience in oncology clinical drug development
Strong leadership competencies and influencing skills with senior leaders and cross functional leaders
Effective oral and written communication skills to influence, inform and guide a large scale global operational team
Broad clinical operational experience in oncology and strong project management skills
Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams

193

Perioperative Clinical Operations Director Resume Examples & Samples

3+ years of Clinical experience in a Hospital and/or Healthcare setting; 3+ years of increasing Nursing responsibility and leadership
Current CT Registered Nurse (RN) license
Endoscopy background
ANCC Nursing Executive or other ANCC recognized Administration certification

194

Analyst, Clinical Operations Resume Examples & Samples

Analytics
1-2 years of related experience in consulting, healthcare analytics, operations strategy or process strategy
Six Sigma green belt preferred but not required
Proficiency in MS Excel, Word and PowerPoint
Strong critical thinking, problem solving and intellectual curiosity
Innovative and flexible thinker with strong project management skills, who can drive multiple projects simultaneously across multiple teams
Dynamic, high energy self-started that can fit in well with a fast paced team and is comfortable with ambiguity
Healthcare industry experience preferred but not required
Travel: required up to 30-40%

195

Manager of Clinical Operations Resume Examples & Samples

Advanced degree preferred
Certification in specialty preferred. (enrollment within the first year of hire required)
Two to five years of experience in management or related role
Experience should include management of personnel, payroll, staff scheduling, contractor recruiting, physician relations and management of supervisory positions
Experience should include high proficiency with computer technology (such as Excel, Access etc.), as well as nursing applications such bed management, and resource scheduling
ACLS, BLS
Must have the ability to manage multiple priorities
Ability to communicate effectively and to work with all levels of hospital personnel
Ability to work both intra and interdepartmentally to advance hospital goals

196

Director of Clinical Operations Resume Examples & Samples

Guide clinical operations and successful collaboration with payors and providers to facilitate the success of CareMore’s home-based model of care within the region to achieve clinical, operational and financial success
Provide thought leadership in developing and implementing care continuity plans and tactics as members transition into the CareMore model
Lead and guide a team of clinical partners and case manager staff (~8 in year 1) to maximum performance
Lead provider network collaboration strategies, including guiding provider implementation and partnerships to facilitate gaining support of the CareMore model
Direct local leadership teams to establish, implement and maintain community outreach and resource strategies that establish program acceptance, positive public relations and critical partnerships
Direct local leadership to establish, implement and maintain member/patient retention strategies to ensure that growth and retention goals are met
Lead location business development and innovation efforts that grow CareMore’s reach within the Connecticut service area
Oversee all operational activities and resource efficiency within the local markets
Partner with regional and local market clinical leaders to exceed clinical outcomes goals that live up to CareMore standards, as well as to deliver Medicare Advantage goals commensurate with CMS HEDIS and Quality expectations
Partner cross-functionally and with peers across the organization to provide new market operational support and infrastructure (E.g., IT; Finance & Accounting; Reporting & Analytics; Quality)
Analyze financial and operational data to uncover performance issues and leading the execution of improvement opportunities
Prepare background analysis and external project documents required to support business development process with collaboration partners
Contribute analyses and presentations as inputs to executive-level materials in support of regular business planning cycle, Joint Operations Committee meetings, and executive leadership updates
Provide leadership in building a culture of teamwork with peers and indirect reports
Collaborate with internal colleagues and external business partners effectively using professional maturity and sound business judgment
Education and/or experience: bachelor’s degree (BA or BS) from a four-year college or university; master’s degree (MBA, MHA, MPH) preferred; over ten years of related experience and/or training; or, equivalent combination of education and experience
Certificates, licenses, registrations: none required
Other qualifications: at least ten years of experience in the field; demonstration of expertise in a variety of the field’s concepts, practices, and procedures
Active driver’s license a must

197

Clinical Operations Lead Resume Examples & Samples

At least 8 years of clinical research study/project management experience, some of which must be in early development. Prior CRO or investigator site and/or monitoring experience is a plus
Inquisitor and comfortable with the unknown
Ability to influence the Lead Study Scientist on clinical study direction based on changing internal and external landscapes within a disease or therapeutic area
Excellent project management skills, including risk assessment and contingency planning
Excellent leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills

198

Medical Assistant, Clinical Operations Resume Examples & Samples

Knowledge and ability to provide appropriate patient care depending on age, cultural, and spiritual needs. Ability to set goals and judge results in accordance with the highest standards. Advance care through development of new ideas and technology. Promote teamwork to achieve CHOC's mission, understanding, and exceeding patient and family expectations. Effectively solve patient care and operational problems. Role model positive and professional behavior
1 year experience in front and back office pediatric medical office/clinic setting
Medical Assistant certification

199

Clinical Operations Risk Manager Resume Examples & Samples

Coordination of Risk Assessment activities
Candidates must be NJ based
Experience with Risk Based Monitoring or Risk Assessment activities (desirable)
Knowlege and experience with Health Authority Inspections, audits and/or CAPA responses
Demonstrated ability to drive change with innovative, independent, creative solutions
Must possess an ability to assert self and drive engagement with development teams

200

Clinical Operations Educ Cnsltnt Resume Examples & Samples

Leads, consults, and mentors the Regional Education Consultant Councils
Facilitates, prioritizes and manages workload and deliverables of REC Councils as assigned
Coordinates skills and competency documents, working in concert with Clinical Education Director, Clinical Program and Services Leadership and other Region Education Consultants
Assesses and identifies education needs through system, regional and facility leadership as well as the Region Education Councils and advocates at the corporate level for system-wide needs
Oversees coordination, completion and ongoing sustainability of Unit Orientation documents, ensuring the task is completed based on specific regulatory guidelines, including recommending delivery methods
Manages REC Council to accomplish unit orientation resource development and standardization for assigned Clinical entities
Facilitates teams in development, implementation and ongoing maintenance of unit / department orientations across the system
Provides education expertise and consultation on corporate teams and task forces to facilitate education development and assignment
Provides consultative services to Clinical Operations departments and special teams / committees to facilitate development, implementation, and evaluation of education plans and to support quality and clinical outcomes
Develops and writes clinical education policies and forms to guide educational practice and support system-wide educational goals
Solicits and integrates feedback from clinical educators and experts with consideration of system-wide implications and manages feedback on all Clinical standardized education documents through the appropriate REC Council through resolution of issue
Supports implementation of clinical programs initiatives and policies through utilization of project management, communication and consultative skills
Collaborates with regional education departments to ensure consistency of programs and practice, adequate response for identified needs and guidance for implementation of central education projects and programs
Provides direction and manages applications, approvals, and record management for standardized clinical education programs as assigned
Oversees education projects in areas of responsibility as prioritized by Clinical Education Leadership
Leads and manages communication and organization of assigned REC Councils. Communicates in a clear and timely manner with internal and external customers/partners. Presents salient information in a cogent, organized manner and provides timely response to questions and requests. Maintains sensitive, confidential information at all times
Master's Degree in Education
National certification in area of expertise

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