Associate Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

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OBJECTIVES/PURPOSE:

• Build lead and scale Takedas 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 Takedas portfolio.

ACCOUNTABILITIES:

• Contribute to implementation and scalability of Takedas 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