Manager, TMF Study Owner Lead
PfizerSummary
The Manager, TMF Study Owner Lead provides managerial oversight and leadership for a team of TMF Study Owners and document processing staff. This role is accountable for delivering TMF-related goals, ensuring completeness, consistency, and compliance of Trial Master Files for assigned clinical trials. The Lead will serve as a Subject Matter Expert for TMF processes and systems, manage escalations, and contribute to process improvements and system enhancements. They will also work with senior leadership to formulate strategies and foster a culture of high customer service.
Required Skills
Details
- Posted
- ~Jun 30, 2026
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 trials and programs in scope (i.e., interventional).
- Creates, maintains and assumes accountability for a culture of high-customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Medical