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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