Associate Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

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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 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

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