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Job Description

OBJECTIVES/PURPOSE:
• Build, lead, and scale Takeda's Clinical & PV Document Excellence Global Capability Center (GCC) as a strategic capability supporting Clinical Development and Pharmacovigilance records managment and inspection readiness globally.

• Provide operational leadership for sponsor-owned TMF operations, quality review services, document processing, inspection readiness support, records stewardship activities, and continuous improvement initiatives.
• Establish a high-performing global team delivering consistent, inspection-ready records management services across Takeda’s portfolio.

ACCOUNTABILITIES:




• Contribute to implementation and scalability of Takeda's Clinical Trial Delivery & PV Documentation Excellence Global Capability Center.

• Drive a high-performing organization responsible for CTD and PV records management, TMF operations, document quality review, records stewardship, inspection readiness support, and operational excellence activities.

• Execute on staffing models, workforce planning strategies, onboarding programs, competency frameworks, training curricula, career development pathways, and succession planning to support long-term capability growth in collaboration with global leadership.

• Oversee day-to-day delivery of sponsor-owned CTD and PV records services, ensuring timely, high-quality, compliant execution of document processing, TMF quality review, reconciliation support, records transfers, inspection readiness activities, and study support services.

• Partner with study teams and functional stakeholders to ensure records management activities support study executi

📌 Associate Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence (Bengaluru)
🏢 Takeda
📍 Bengaluru