Job Description

The Trial Master File (TMF) Study Owner (SO) Lead provides managerial oversight of document management deliverables of assigned TMF Study Owners (SOs) and/or document processing staff (e.g., TMF Study Owner Associates, TMF Document Specialists). The TMF SO Lead:

  • Is accountable to TMF Operations LT for delivery of TMF-related goals.
  • Manages, trains, and mentors/coaches TMF SOs and/or document processing staff to ensure completeness, consistency, compliance of TMF for assigned clinical trials from study start to study close/submission.
  • Serves as Subject Matter Expert for TMF process, systems and related tools.
  • Is the primary point of issue escalation for assigned TMF SOs and/or document processing staff.
  • Contributes to the implementation of new and revised TMF process standards and system upgrades/enhancements.
  • Works closely with the TMF Operations Head and Leads formulating strategies and specifications to be implemented for all clinical...

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