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The Manager, Clinical Programs reports to the Associate Director, Clinical Programs and is responsible for the oversight, growth and development of our in-house and remote Clinical Program Managers, Clinical Project Managers and Clinical Trial Coordinators. The Manager, Clinical Programs works in collaboration with the Associate Director, Clinical Programs and is expected to manage all clinical programs activities including accelerating the planning, start-up, maintenance and closeout activities of Abiomed’s clinical studies through the development and execution of Clinical SOPs and processes in support of Clinical Programs. This person will train, manage, and develop Clinical Program personnel to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of subjects is ensured with the highest level of data quality and integrity.
Principle Duties and Responsibilities:
- Responsible for hiring, training and retaining a diverse group of in-house and remote Clinical Program Managers, Clinical Project Managers and Clinical Trial Coordinators, ensuring adherence to pertinent regulations through regular review of system metrics, Trial Master File review, communications with cross functional stakeholders and others as needed
- Accountable for the development of direct reports through performance reviews, instruction, mentoring and coaching. This includes setting goals, conducting periodic and year end performance reviews, proactively identifying and addressing any areas of concern, providing development opportunities to team members and as needed, escalating performance and/or personnel issues
- Hands on leadership to manage integration of all project team activities including clinical program management metrics, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources (when necessary), expertise and knowledge
- Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies and be responsible for leading project management activities for selected studies
- Effectively communicate and interact with Key Opinion Leaders
- Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
- Lead the development of contingency/risk management plans for projects and assist Associate Director, Clinical Programs in the preparation and execution of sound development strategies
- Interface with Finance, Program Managers, Accounting, Quality, Regulatory, Medical Affairs; which may include leading sub-teams and/or acting as a liaison between groups.
- Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies and seeks continuing education
- Participates in inspection readiness activities and audit activities performing Trial Master File (TMF) data management audits on a regular basis
- Supports Associate Director, Clinical Programs, Clinical Program Managers and Quality Assurance to ensure that all CAPAs are adequately developed, reviewed and implemented
- Facilitates collaborative environment through team building activities and leadership
- Assist Associate Director, Clinical Programs in preparation of Clinical Program study budgets and timelines for Worldwide Profit Planning (WWPP) projections for senior management for current and proposed studies
- Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
- 6+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
- 4+ years clinical project management experience with global clinical studies.
- Strong regulatory knowledge, including Good Clinical Practices (GCPs)
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
- Excellent communication (written and verbal) and presentation skills along with leadership qualities.
- Knowledge of global clinical trial management in fast paced environment. Ability to assemble a plan and execute on the details.
- Apply project management best practices to programs. Experience in cardiovascular medical device studies
- Experience with protocol, ICF, CRF, CSR development and review.
- Strong organizational skills and ability to deal with competing priorities.
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
- Ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment