Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role reporting to the Sr. Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

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.

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