Trial Master File Associate
Job Summary
To support clinical trial documentation management, the remote Trial Master File (TMF) Associate will ensure the accuracy and completeness of TMF records, perform quality control reviews, and collaborate with various stakeholders to maintain an inspection-ready environment.
Key responsibilities:
- Maintain assigned study TMFs, ensuring documents are filed accurately and according to standards
- Perform routine quality control reviews to identify and resolve issues with TMF documentation
- Monitor TMF health metrics and communicate risks and outstanding issues to stakeholders
Required qualifications:
- Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent
- 2-4+ years of experience in TMF management or clinical research within biotechnology, pharmaceutical, or CRO environments
- Working knowledge of CDISC TMF Standard Model and ICH-GCP guidelines
- Experience maintaining electronic Trial Master Files (eTMF) in regulated environments
- Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms
Complete Job Description
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