TMF Associate, TMF Center of Excellence

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Job Description

OBJECTIVES/PURPOSE:

• Responsible for independently executing and coordinating TMF and PV records management activities, including eTMF processing, second-line quality control, quality review, issue resolution, and TMF inspection readiness across Takeda’s global portfolio.

• Applies strong knowledge of TMF requirements, clinical trial processes, and document standards to ensure records are complete, accurate, consistent, and inspection-ready.

• Provides day-to-day operational guidance to TMF operations team, supports complex or escalated activities, and promotes consistent application of approved processes and standards.