TMF Manager

Stratacuity: Proven Scientific Placement; Cambridge (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading biopharmaceutical recruitment firm based in Cambridge is seeking a detail-oriented TMF Manager. This role ensures Trial Master Files (TMFs) are inspection-ready and comply with ICH GCP and GDP standards. Responsibilities include managing clinical documentation quality, overseeing eTMF systems, and leading vendor interactions. The ideal candidate has a bachelor’s in a science field and 5+ years eTMF experience. This is an excellent opportunity for self-starters in a fast-paced environment passionate about clinical documentation excellence.

Qualifications

• 5+ years of eTMF experience in pharma, biotech, or CRO.
• Deep knowledge of TMF Reference Model and clinical documentation standards.
• Experience with SOP development and vendor oversight.

Responsibilities

• Manage clinical document quality, control, and review.
• Oversee internal eTMF systems and support CRO eTMF platforms.
• Lead vendor interactions and provide eTMF training.

Skills

eTMF experience

Communication skills

Training and cross-functional collaboration

Education

Bachelor’s degree in a science or health-related field

Tools

eTMF systems

Job description

Our Cambridge based client is seeking a detail-oriented TMF Manager to ensure their Trial Master Files (TMFs) are inspection-ready and aligned with ICH GCP and GDP standards. You’ll support internal teams and CROs in maintaining high-quality documentation across clinical studies.

Key Responsibilities:

• Manage clinical document quality, control, and review
• Oversee internal eTMF systems and support CRO eTMF platforms
• Lead vendor interactions and provide eTMF training
• Maintain SOPs, filing guides, and documentation standards
• Collaborate cross-functionally to drive process improvements

Qualifications:

• Bachelor’s degree in a science or health-related field
• 5+ years of eTMF experience in pharma, biotech, or CRO
• Deep knowledge of TMF Reference Model and clinical documentation standards
• Experience with eTMF systems, SOP development, and vendor oversight
• Strong communication, training, and cross-functional collaboration skills
• This is a great opportunity for a self-starter who thrives in a fast-paced environment and is passionate about clinical documentation excellence.

About Stratacuity:

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