Manager, TMF Study Owner Lead

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.

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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Global pharmaceutical company developing vaccines, oncology, and immunology treatments. Headquartered in New York, NY.

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