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.

  
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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