Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

Goals

Information Management (RIM) steward. Oversee preservation of and access to archived clinical records in support of study close-out, inspection readiness, acquisitions, divestments, and records management initiatives. Serve as subject matter expert and execution lead for study team-facing support across the inspectable records lifecycle for complex or business-critical trials. Drive consistent, high-quality execution of clinical and PV records activities across the portfolio.

Accountabilities

• Manage TMF and PV documentation activities across the portfolio acting as a primary point of contact for TMF/PV documentation topics with Clinical Trial Delivery, Medical and PV functions, and within R&D Quality.
• Collaborate with cross-functional representatives and external partners to promote records excellence and ensure archived clinical records remain retained and accessible in support of Takeda records management policies, clinical trial delivery, regulatory filings and submissions, acquisitions, and divestments.
• Coordinate and manage TMF processes and inspection readiness strategies in partnership with study execution teams and Clinical and PV Documentation Excellence.
• Lead end-to-end subject matter expertise and support for TMF activities related to acquisitions and divestments, including due diligence, migrations, integration, records reconciliation, quality oversight, transfer management, and study team and vendor support.
• Oversee and maintain physical records room operations, including archiving, indexing, and retrieval of critical physical records, as well as management of clinical records stored globally at Takeda external vendor off-site facilities.
• Manage and maintain electronic records in Takeda content management systems and third-party databases.
• Manage oversight and delivery for Takeda clinical records management archival vendors.
• Maintain tracking mechanisms that enable efficient identification of clinical records across systems and locations.
• Support preparation of documentation required for regulatory inspections and internal audits.
• May stand in front of inspector(s) during inspection(s).
• Contribute to company and department goals by leading initiatives that optimize clinical records management, improve efficiency, and advance automation, including records transfer and consolidation, divestment support, annual destruction, and retention reviews.
• Provide high-quality customer service and records support across all levels of the organization.
• Serve as the RIM steward for all TMF records
• Provide project management, oversight, and expert records guidance to study execution teams for inspection preparation, readiness checks, and backroom inspection and audit support.
• Assist with audit and Health Authority inspection responses, CAPAs and actions.
• Identify gaps and escalate risks related to TMF and PV documentation quality.
• Support implementation of SOPs, WIs, process improvements and technology enhancements
• Support onboarding, training and quality delivery of internal global capability center and external resources

Education and Experience

• Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
• 6+ years of progressive experience in pharma/biotech/CRO environments with expertise in TMF/eTMF and/or PV documentation, including 2+ 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 CDISC TMF Reference Model, TMF plans/Expected Document Lists (EDLs), and risk-based TMF QC/health check approaches to maintain continuous inspection readiness.
• Demonstrated experience in records management programs; pharmaceutical records management experience and knowledge of related regulatory requirements preferred.
• Proven ability to work independently, take initiative, and complete tasks by established deadlines.
• Strong attention to detail, document organization, prioritization, scheduling, and deadline management skills.
• Strong communication skills and customer focus, with the ability to work effectively in a global, cross-functional organization.
• Proactively identifies continuous improvement opportunities that increase operational efficiency through process and metrics analysis.
• Applies lessons learned to continuously improve documentation management practices across study teams and share knowledge with stakeholders as needed.
• Demonstrated capability in governance, vendor management, and performance management, including SLA/KPI design, root cause analysis, CAPA oversight, and escalation management.
• Technology acumen, including hands-on familiarity with eTMF platforms, metrics, reporting/dashboards, and the ability to partner with systems/IT to optimize workflows, metadata quality, and controls; PV systems experience, such as safety databases, preferred.
• Strong communication, influencing, and negotiation skills, with the ability to drive cross-functional alignment and accountability.