Director, Clinical Operations Job Description
Director, Clinical Operations Duties & Responsibilities
To write an effective director, clinical operations job description, begin by listing detailed duties, responsibilities and expectations. We have included director, clinical operations job description templates that you can modify and use.
Sample responsibilities for this position include:
Director, Clinical Operations Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Clinical Operations
List any licenses or certifications required by the position: BLS, CPC, PMP, CPR, BCLS, PALS, ANCC, APICS, CPI, CCRP
Education for Director, Clinical Operations
Typically a job would require a certain level of education.
Employers hiring for the director, clinical operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Management, Health, Public Health, Business, Science, Health Care, Healthcare Administration, Education, Supervision
Skills for Director, Clinical Operations
Desired skills for director, clinical operations include:
Desired experience for director, clinical operations includes:
Director, Clinical Operations Examples
Director, Clinical Operations Job Description
- Work closely with other groups within Janssen to plan for and to ensure continuity of programs as they transition from early to late stage development
- Assures clinic perform with high standards of care, measure and improve clinical work flows, and implement standard best practices
- Manages clinical space utilization and requests
- Promotes practice growth and collaboration between BCM and CHI/St
- Work 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
- Monitors 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
- Standardizes faculty practice operations, processes, policies and procedures
- Manages studies of products independently and resolves simple to complex issues to move clinical development of products forward
- Trains internal and third party team members as appropriate to meet business needs
- Cultivates a strong and transparent working relationship with the Executive Team and ensures open communication about the measurement of financial, programmatic, and impact performance against stated milestones and goals
- Manage the progress of clinical studies and ensure adherence to the protocol, timelines, and budget
- Develop and manage clinical trial budgets
- Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools
- Relationship Management – Must be able to manage the relationship with CROs and other service providers that includes clinical study site staff, such as investigators, study coordinators, pharmacists, other relevant functional team members
- Minimum of 8 years of experience pharmaceutical or biotechnology drug development experience
- Experience managing clinical quality activities and knowledge of clinical operations
Director, Clinical Operations Job Description
- Assimilates information from variety of sources, able to analyze data and make recommendations and executes a course of action
- Provides leadership in guiding specific hospitals, hospital systems, IDNs, and Parallon Business Solutions as it relates to clinical pharmacy services strategy
- Assist in developing and achieves established targets
- Develops, implements, and coordinates within the hospital or system policies and procedures related to implementation of clinical pharmacy operations
- Support external pharma/biotech audits
- Work directly with pharma/biotech customers to carry out assay validations and early phase clinical studies
- Develops and manages study budget and maintains it within financial goals
- 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
- Obtain regular feedback on employees from other clinical project team members and key stakeholders to facilitate ongoing performance management and development
- Direct, manage and mentor an assigned team of Clinical Operations staff who lead and/or manage those who lead studies or programs
- BS/BA degree in a scientific or medical discipline
- Ability to perform medical literature reviews, interpreting and presenting scientific/clinical trial data
- Strong knowledge of Good Clinical Practices including US 21 CFR and ICH E6
- College degree in the life sciences required
- Considerable periods of time may be spent concentrating and or analyzing data
- Experience with clinical trial systems (CTMS, EDC, IVR, ) and clinical trial processes
Director, Clinical Operations Job Description
- Direct the delivery against key metrics, milestones, and contractual obligations for a portfolio of projects to encompass expectation setting and management against quality, time and financial objectives
- Serve as the primary operational management contact globally to the designated customer account
- Lead the review of a customer pipeline, opportunities pending, and future customer needs in support of the quarterly development of resource forecasts for delivery to the cost centers providing resources to the designated customer account
- Act as the key relationship manager for designated customer
- Team member responsible for participation in the development and support of customer sales initiatives
- Provide strategic clinical operations oversight and direction ensuring collaboration across a project(s) to translate our science into reality through high quality clinical trial conduct
- Ensure the activities that impact projects are executed according to the clinical development plan
- Develop and execute program-specific project and risk management plans (milestones, metrics, critical path) ensuring and appropriate escalation as needed
- Set program-level enrollment strategy including country and site selection plan and timelines to meet program objectives
- Ensure program-level Investigational Product supply strategy meets the needs of the clinical program (s)
- Experience of Clinical Trial execution, either as Operations or one of the support groups
- Experience of developing or using technologies designed to enable efficient execution of clinical trials
- Experience of enterprise architecture a plus, but not a requirement
- Project management experience in the eClinical/Technology or Clinical Trials domain a plus
- Must have previous start-up and overall mgmt
- In-depth experience within clinical research with specialist experience in leadership and senior management
Director, Clinical Operations Job Description
- Partner with Quality Assurance to develop the strategic plan for regulatory audits and inspections
- Evaluate study-level issues for broader impact (e.g., cross-study, ) in a timely fashion and ensure resolution
- Key contributor to a project or program documents
- Represent the clinical operations function at advisories, interactions with regulatory agencies and evaluation of business opportunities (due diligence)
- Participate in resource prioritization across teams to ensure clinical operations strategic goals and milestones are achieved
- Matrix management of a team of clinical operations personnel assigned to plan, implement and execute clinical trials
- Strategic planning and execution of a project(s) in collaboration with the therapeutic area and relevant groups
- Effective clinical operations oversight to ensure on time delivery of project(s) within the pipeline
- Core member of strategic governance body (e.g., GPT), interacts with all functions supporting clinical development
- Responsible for developing and managing project budget (typically up to $500MM)
- Minimum of 10-12 years’ experience in clinical research and at least 5 years of experience managing clinical research teams in Argentina
- Significant clinical trial management experience with demonstrated success required
- Positive proven success in people management and project management
- Working knowledge of MSD’s core business structure and how own function contributes to and works within the organization
- Ability to think cross-functionally and working across boundaries internationally
- Demonstrated ability to build relationships with senior business executives
Director, Clinical Operations Job Description
- Manage and analyze external regulatory outcome data reports
- Conduct regulatory related education/training programs for all levels of the organization
- Facilitate / coordinate resources for communities in need of additional regulatory compliance support
- Maintain current knowledge of current/proposed federal and state regulations and communicate to all levels of the organization
- Partner with DDH and RDH team to implement programs (SNF/HC & AL)
- Coordinate and manage clinical program/policy manuals (HC/SNF, AL, IC, Orientation, Medical Records)
- Regularly monitors accrual rates at sites to determine if sites are meeting requirements (ACoS, Alliance, NAPBC)
- Establishes relationships with Duke Investigators to promote trial sharing
- Evaluates the feasibility of proposed studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies
- Coordinates and establishes clinical trials schedules, task assignments and allocation of manpower and equipment to ensure conformance with specified objectives
- Bachelors Degree or international equivalent required, Life Sciences preferred
- Fluency in English, Spanish is required and Portuguese is desirable
- In-depth experience working on clinical trials with established experience in a leadership capacity across a portfolio of work
- Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm and commitment, and to gain approval/sponsorship for projects
- Minimum 15 years pharmaceutical industry experience required
- Global experience and leadership experience required, preferably with oncology project development