Director, Editor in Chief
Autodesk
Associate Director, TMF Management – SOP Development
Generate Biomedicines
full-time
Posted on:
Location Type: Hybrid
Location: Somerville • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $160,000 - $224,000 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformVault
About the role
- Responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process
- Serve as the subject matter expert (SME) for all TMF-related activities
- Oversee the eTMF system and all related processes
- Lead the creation and continuous improvement of Clinical Operations Standard Operating Procedures (SOPs)
Requirements
- 7+ years of relevant TMF experience, SOP development, and/or operations leadership
- In depth knowledge of relevant regulations and GCP
- Deep understanding of ICH-GCP, 21 CFR Part 11, TMF Reference Model, and clinical trial lifecycle
- Proficient knowledge of CDISC Reference Model
- Strong working knowledge of clinical study documentation
- Proficiency in Veeva Vault eTMF and Microsoft Office Suite
- Extensive experience working with eTMF systems and CRO oversight
- BA/BS required; life sciences or related field preferred
Benefits
- Competitive benefits package
- Annual bonus
- Equity compensation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
TMF experienceSOP developmentGCP knowledgeICH-GCP21 CFR Part 11TMF Reference ModelCDISC Reference Modelclinical study documentationeTMF systemsCRO oversight
Soft skills
strategic leadershipoperational oversightquality governancesubject matter expertcontinuous improvement
Certifications
BA/BSlife sciences degree
