Base pyy salary range determined by role level + l...
On-site
8+ years pharmaceutical regulated environment experience
6+ years records management field experience
4+ years electronic records management systems usage
Revolution Medicines is seeking a Clinical TMF Manager for its clinical operations team in Redwood City, California. The role involves overseeing Trial Master File management and ensuring adherence to regulatory standards while supporting clinical study execution teams
Job Summary
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.
The role involves acting as a central contact for Clinical Study Execution Teams to manage Trial Master Files and develop quality oversight processes.
Candidates must supervise TMF specialists and external vendors to ensure study documents adhere to ICH-GCP guidelines and are inspection-ready.
Matching Summary
Match Score: 85
Revolution Medicines is seeking a Clinical TMF Manager for its clinical operations team in Redwood City, California. The role involves overseeing Trial Master File management and ensuring adherence to regulatory standards while supporting clinical study execution teams.
Salary
Base pay salary range determined by role level and location; includes competitive cash compensation robust equity awards strong benefits significant learning opportunities
Skills & Requirements
Must-have
8+ years pharmaceutical regulated environment experience
6+ years Records Management field experience
4+ years electronic records management systems usage
Strong knowledge of FDA Regulations ICH Guidelines GCP
Experience with eTMF and CTMS systems integration
Nice-to-have
Oncology experience in early or late stage trials
Direct experience managing direct reports
Familiarity with Ex-US region clinical trial operations
Collaboration with DIA CDISC TMF Reference Model
Proficiency in Microsoft Project or Smartsheet
Key Requirements
Minimum 8 years pharmaceutical or regulated corporate experience