Hybrid Senior Manager, TMF & PV Documentation Excellence

Takeda; Cambridge (MA); Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role in Cambridge, MA. You will oversee TMF and PV documentation, ensure inspection readiness, and collaborate with Clinical Trial Delivery, Medical, PV, and QA to maintain high-quality records across the portfolio.

The role requires strong TMF/eTMF expertise, regulatory knowledge, and program management skills, with focus on data integrity, lifecycle governance, and continuous

Qualifications

• Experience in TMF/eTMF programs and data integrity
• Understanding of ICH/EU regulatory requirements and 21 CFR Part 11

Responsibilities

• Oversee TMF and PV documentation across the portfolio
• Lead inspection readiness activities and support regulatory filings
• Coordinate with study teams, vendors, and QA to ensure records quality
• Drive process improvements for records management and automation
• Provide expert guidance on TMF lifecycle and divestment activities
• Support audits and inspections with preparedness and evidence collection

Skills

TMF/eTMF knowledge

Regulatory knowledge

Cross-functional collaboration

Project management

Education

Bachelor's degree in life sciences

Tools

eTMF systems

Job description

Takeda is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role in Cambridge, MA. You will oversee TMF and PV documentation, ensure inspection readiness, and collaborate with Clinical Trial Delivery, Medical, PV, and QA to maintain high-quality records across the portfolio.

The role requires strong TMF/eTMF expertise, regulatory knowledge, and program management skills, with focus on data integrity, lifecycle governance, and continuous