Associate Director, Clinical Tmf Management (clinical Operations)

Revolution Medicines

Redwood City, United States
On-site
Trial master file strategy and standards
Etmf system vendor management
Ich guidelines and gcp adherence
Revolution Medicines is seeking an Associate Director of Clinical TMF Management to lead and oversee Trial Master File (TMF) activities in their clinical operations team. The ideal candidate will possess strong leadership and organizational skills, with extensive experience in TMF management within a regulated environment

Job Summary

  • Responsible for the development and oversight of the Trial Master File strategy and standards, in support of Revolution Medicines clinical trials.
  • Lead and develop a team of CORE TMF Managers responsible for administration, operational oversight, and quality management of the TMF.
  • Champion innovation in TMF management through implementation of technology-enabled solutions to enhance document quality, reconciliation, reporting, and inspection preparedness.

Matching Summary

Match Score: 85

Revolution Medicines is seeking an Associate Director of Clinical TMF Management to lead and oversee Trial Master File (TMF) activities in their clinical operations team. The ideal candidate will possess strong leadership and organizational skills, with extensive experience in TMF management within a regulated environment.

Skills & Requirements

Must-have

  • Trial Master File strategy and standards
  • eTMF system vendor management
  • ICH Guidelines and GCP adherence
  • inspection readiness strategy and execution
  • CDISC TMF Reference Model expertise

Nice-to-have

  • AI-supported solutions implementation
  • cross-functional collaboration leadership
  • driving operational excellence

Key Requirements

  • 11+ years progressive experience in regulated environments
  • 7-10 years direct industry experience in TMF/eTMF management
  • 5 years people management experience
  • RN or Bachelor’s or Master’s degree

Work Rights

Not specified

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