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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 solid 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.
• Drives operational efficiency and quality through risk identification, workflow improvement,



standardization, automation, and data-informed oversight.

ACCOUNTABILITIES:
• Independently execute and coordinate eTMF document processing, classification, indexing, maintenance, reconciliation, and quality control activities in accordance with applicable SOPs, regulations, and study requirements.

• Perform and document second-line quality review of complex records and workflows to confirm completeness, accuracy, consistency, metadata quality, and compliance with established standards.

• Identify, investigate, and resolve record quality issues, metadata discrepancies, and workflow exceptions; escalate significant compliance risks through established channels.

• Perform effective periodic quality review, ensuring timely, accurate and complete records in adherence with applicable processes and regulations.

• Provide day-to-day guidance, peer support, and quality feedback to TMF and PV Docum

📌 TMF Associate, TMF Center of Excellence (Bengaluru)
🏢 Takeda
📍 Bengaluru