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Job Description

OBJECTIVES/PURPOSE:
• Oversee the management, maintenance and compliance of TMF and PV records management operations in the TMF Center of Excellence global capability center

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

• Provides development, training and operational guidance to staff, supports complex or escalated activities, and ensures consistent application of approved processes and standards.
• Drives operational efficiency and quality through risk identification, workflow improvement, standardization, automation, and data-informed oversight.

ACCOUNTABILITIES




• Lead day-to-day TMF and PV records management operations within the TMF Center of Excellence Global Capability Center, ensuring timely, accurate, and compliant execution of document processing, filing, indexing, quality review, and records support activities.

• Provide people leadership, coaching, workload management, and performance oversight for a team of TMF Associates supporting global TMF and PV documentation operations.

• Ensure TMF and PV records activities support inspection readiness through complete, accurate, reliable, and retrievable records maintained throughout the record lifecycle.

• Monitor team delivery against quality, productivity, service, and compliance expectations, and implement actions to address gaps and improve operational performance across the capability center.

• Conducts quality review, TMF health checks and monitors KPI in collaboration with the study team for complex and business

📌 TMF Lead, TMF Center of Excellence, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence (Bengaluru)
🏢 Takeda
📍 Bengaluru