Associate Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

Takeda; Bengaluru; On-site; INR 4,200,000 - 6,200,000; Full time

Job summary

Takeda Bengaluru seeks an experienced leader to build and scale the Clinical & PV Documentation Excellence GCC, driving CTD and PV records management, TMF operations, and inspection readiness.

You will partner with global teams to implement governance, quality controls, and continuous improvement across study records, ensuring regulatory compliance and timely deliverables.

Qualifications

• Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
• 8+ years in pharma/biotech/CRO with TMF/eTMF and PV documentation.
• Experience collaborating with global teams, vendors, and stakeholders (3+ years).
• Strong regulatory knowledge: ICH E6, 21 CFR Part 11, EU CTR/GVP.
• Knowledge of TMF Reference Model, EDLs, and TMF QC/health check approaches.
• Experience in records management and regulatory requirements in pharma.

Responsibilities

• Lead and scale Takeda's Clinical & PV Documentation Excellence GCC.
• Oversee CTD and PV records management, TMF operations, and inspection readiness.
• Drive staffing models, onboarding, training, and career development with global partners.
• Ensure timely, compliant document processing and quality reviews.
• Partner with study teams to support study execution and regulatory compliance.
• Monitor service delivery metrics and drive continuous improvement.
• Lead quality management activities, risk assessments, CAPA, and governance.
• Support regulatory inspections and Health Authority requests.

Skills

TMF/eTMF knowledge

Regulatory compliance

Quality management

Governance

Vendor management

Data integrity (ALCOA+)

Cross-functional collaboration

Education

BSc/BA or equivalent

Tools

Veeva eTMF

PV databases

Reporting dashboards

Job description

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 execution, sponsor oversight, inspection readiness, and regulatory compliance.

• Establish and monitor service delivery, operational performance, quality, compliance, productivity, and inspection readiness metrics; drive actions to continuously improve organizational performance and service maturity.

• Lead quality management activities across GCC operations, including quality review strategies, risk assessments, issue escalation, corrective and preventative actions, root cause investigations, and continuous improvement initiatives.

• Ensure all operational activities support inspection-ready outcomes and maintain complete, accurate, reliable, and retrievable records throughout the study lifecycle.

• Support regulatory inspections, audits, inspection readiness exercises, and Health Authority requests by coordinating operational readiness activities, document retrieval, records support, and response fulfillment.

• Drive standardization, simplification, and optimization of business processes supporting Clinical and PV records management, TMF operations, records stewardship, and inspection readiness.

• Partner with US-based leadership to implement enterprise records strategies, inspection readiness frameworks, records governance requirements, and future-state operating models.

• Lead adoption and optimization of process and technology improvements and emerging digital tools supporting CTD & PV Document Excellence.

• Drive implementation of innovative solutions, including AI-enabled document processing, metadata management, quality controls, analytics, workflow automation, and operational intelligence capabilities.

• May support records stewardship activities supporting archive preparation, records transfers, acquisitions and divestitures, legal holds, records retention programs, archive retrieval services, and long-term preservation requirements in collaboration with US-based records leadership.

• Represent CTD & PV Documentation Excellence in governance forums, operational reviews and inspection readiness discussions.

• Build a culture focused on quality, compliance, operational excellence, innovation, accountability, inspection readiness, customer service, and continuous improvement.

_ EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: _

• Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
• 8+ years of progressive experience in pharma/biotech/CRO environments with expertise in TMF/eTMF and/or PV documentation, including 3+ years collaborating with global teams, vendors, and cross-functional stakeholders.
• Strong knowledge of applicable regulations and guidance (e.g., ICH E6 (R2/R3), 21 CFR Part 11, EU CTR as applicable, and EU GVP), with demonstrated application of ALCOA+ / data integrity and Good Documentation Practices.
• Strong understanding of the DIA TMF Reference Model, TMF plans/Expected Document Lists (EDLs), and risk-based TMF QC/health check approaches to maintain continuous inspection readiness.
• Demonstrated ability of records management program. Experience in pharmaceutical records management and understanding of associated regulatory requirements preferred.
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines.
• Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines.
• Strong communication skills and customer focus with ability to interact in a global, cross-functional organization.
• Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
• Applies lessons learned to continuous improvement of documentation management practices across study teams and knowledge sharing with stakeholders as needed.
• Demonstrated capability in governance, vendor management, and performance management (SLA/KPI design, root cause analysis, CAPA oversight, escalation management).
• Technology acumen: hands-on familiarity with eTMF platforms (Veeva preferred) and reporting/dashboards; ability to partner with systems/IT to optimize workflows, metadata quality, and controls. PV systems exposure (e.g., safety databases) preferred.
• Good communication, influencing, and negotiation skills; able to drive alignment and accountability cross-functionally.
• Proficiency in Microsoft Office applications and skilled in adopting automation, analytics, and digital workflow tools

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time