TMF Manager: Documentation Excellence & eTMF Lead

Stratacuity: Proven Scientific Placement; Cambridge (MA); Sur place; USD 85 000 - 115 000; Plein temps

Résumé du poste

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.

Responsabilités

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

Connaissances

eTMF experience

Communication skills

Training and cross-functional collaboration

Formation

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

Outils

eTMF systems

Description du poste

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.