The Sr Manager, Clinical Affairs
-Interfaces with physicians to effectively evaluate protocol strategies
-Participates in strategic planning and product development functions as necessary.
-Develops, executes and manages clinical trials ..POST MARKET studies
-Understands and implements project management principles to prioritize, plan, delegate and evaluate deliverables and effectively manages clinical trial budgets and timelines.
-Participates in planning and implementation of new clinical study programs and the development of clinical study protocols. Reviews study protocols to ensure consistency with company objectives, regulatory compliance requirements and adequacy of study design. Reviews and approves final Case Report Forms (CRF), informed consent documents (ICF), Instructions for Use (IFU), investigator brochures (IB), patient guide and site training materials.
-Oversees the direction, planning, execution and interpretation of clinical studies
-Provides regular clinical trial updates to Senior management
-Provides performance metrics, communicates and implements performance objectives to staff;
-Establishes and interfaces with Clinical Events Committee and Data Safety Monitoring Board
-Participates in development and review of regulatory strategies and reports submitted to the FDA
-Maintains high level of professional experience through familiarity with clinical literature.
-Partners with R&D, Clinical Data Management, Biostatistics, Quality and other cross-functional partners to maintain highest quality of clinical research.
-Manages CROs, when required, during study execution phase.
-Manages a team
-BA/BS in a science related field, or Nursing
- A minimum of 5 years of clinical study management experience in medical devices,
-1-2 years of project management experience.
- A minimum of 5+ years managing a team
Boston area residence preferred
Interesed Candidates; please submit your resume to firstname.lastname@example.org
Attention Donne Paine