Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence to lead TMF and PV documentation across the portfolio.

You will partner with Clinical Trial Delivery, Medical and PV functions to ensure inspection readiness and high-quality documentation across global sites. The role requires strong regulatory knowledge, program management, and continuous improvement mindset to enhance records management and automation

Qualifications

• 6+ years in pharma/biotech/CRO with TMF/eTMF and/or PV documentation
• 2+ years collaborating with global teams, vendors and cross-functional stakeholders
• Strong knowledge of ICH E6 (R2/R3), 21 CFR Part 11, EU CTR and EU GVP
• Understanding of CDISC TMF Reference Model and TMF plans/EDLs
• Experience in records management programs and regulatory requirements
• Proven ability to work independently, meet deadlines, and improve processes

Responsibilities

• Manage TMF and PV documentation activities across the portfolio.
• Collaborate with cross-functional representatives and external partners to ensure records retention and accessibility.
• Coordinate and manage TMF processes with study execution teams and Documentation Excellence.
• Lead end-to-end TMF activities for acquisitions/divestments including due diligence and migrations.
• Oversee physical records room operations and off-site storage facilities.
• Maintain electronic records in Takeda content management systems and third-party databases.

Skills

Leadership

Cross-functional collaboration

Project management

Communications

Regulatory awareness

Process improvement

Education

BSc/BA or equivalent

Tools

eTMF platforms

PV systems / safety databases

Job description

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 escalates 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge - Kendall Square - 500

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.