3h ago
Associate Director, Clinical TMF Management (Clinical Operations)
Redwood City, California, United States
full-timedirectorbiotechnology
Tech Stack
Description
You will lead and oversee Trial Master File (TMF) strategy and standards for Revolution Medicines' clinical trials, ensuring inspection readiness and compliance with GCP/ICH guidelines. You will manage a team, drive continuous improvement, and collaborate across functions to support the development of novel cancer therapies.
Requirements
- Explicitly stated in text - not extracted
- Innate leadership and organizational skills
- Technical expertise in clinical TMF management
- Experience in development and implementation of clinical systems strategy
Responsibilities
- Provide strategic leadership and oversight of TMF activities across the portfolio
- Lead and develop a team of CORE TMF Managers
- Oversee TMF system strategy, vendor management, and continuous improvement
- Establish TMF governance, standards, and inspection readiness frameworks
- Participate in audits and regulatory inspections, providing document strategy support
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