TMF Manager

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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