Senior Manager, Trial Delivery & PV Documentation

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (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 across the portfolio, act as SME, and partner with Clinical Trial Delivery, Medical, PV, and QA.

The ideal candidate has 6+ years in pharma/biotech/CRO with TMF/eTMF, regulatory knowledge (ICH E6, 21 CFR Part 11, EU CTR), strong governance and vendor management, and a track record of process improvements and

Qualifications

• BSc/BA in life sciences or equivalent with 6+ years in pharma/biotech/CRO.
• Expertise in TMF/eTMF and PV documentation with global collaboration.
• Strong knowledge of ICH E6, 21 CFR Part 11, EU CTR and GVP.
• Ability to work independently, manage timelines, and improve processes.

Responsibilities

• Oversee TMF and PV documentation across the portfolio with cross-functional partners.
• Lead inspection readiness strategies and TMF activities for acquisitions/divestments.
• Manage physical and electronic records, including off-site facilities.
• Support regulatory inspections and internal audits with high-quality documentation.

Skills

TMF/eTMF

PV documentation

ALCOA+

Cross-functional

Regulatory knowledge

Data integrity

Vendors management

Governance

Process improvement

eTMF systems

Education

Life sciences degree

Tools

eTMF platforms

Content management systems

Regulatory databases

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 across the portfolio, act as SME, and partner with Clinical Trial Delivery, Medical, PV, and QA.

The ideal candidate has 6+ years in pharma/biotech/CRO with TMF/eTMF, regulatory knowledge (ICH E6, 21 CFR Part 11, EU CTR), strong governance and vendor management, and a track record of process improvements and