TMF Specialist; FSP
Job in
Bedford, Middlesex County, Massachusetts, 01730, USA
Listed on 2026-09-13
Listing for:
ProPharma
Full Time
position Listed on 2026-09-13
Job specializations:
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
- Support Trial Master File (TMF) set-up, maintenance, update, archival and closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations.
- Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving.
- Conduct detailed and appropriate quality checks (QC) on TMF documents at defined time points, including any paper originals required.
- Ensure that privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with retention practices.
- Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines.
- Other duties as assigned.
Skills and Abilities:
- Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Exhibits a good understanding of general quality assurance concepts and practices.
- Highly organized with a strong attention to detail.
- Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.).
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