Senior Manager, TMF & PV Documentation Excellence

Takeda Pharmaceutical Co.; Cambridge (MA); Hybrid; 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

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