- Actalent (Jersey City, NJ)
- The Manager , TMF Operations role ensures a complete, accurate, and high-quality Trial Master File (TMF) as the subject matter expert through proper, ... Completeness Reviews to maintain an inspection readiness state throughout the clinical trial . + Facilitate the planning and execution of periodic TMF content… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... to, assisting with masked investigational product, set up and management of unmasked trial master file , review of unmasked data in the electronic data… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring ... team members and cross-functional partners. Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans.… more
- Sanofi Group (Morristown, NJ)
- …review for safety data and statistical surveillance for efficacy data, ) + Ensure trial master file documents readiness and availability, and mandatory ... Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results +… more