PFM is seeking a remote Quality Review Specialist to conduct periodic TMF Quality Reviews for smaller studies within their Precision portfolio. The ideal candidate will have a background in regulatory compliance, strong organizational skills, and experience with eTMF systems
Job Summary
The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews to ensure study files are maintained in an audit-ready manner.
This role involves monitoring document processing issues, escalating inconsistencies, and supporting updates to expected documents within the TMF system.
Candidates must possess a working knowledge of FDA and ICH/GCP regulations to effectively evaluate the completeness status of assigned study TMFs.
Matching Summary
Match Score: 85
PFM is seeking a remote Quality Review Specialist to conduct periodic TMF Quality Reviews for smaller studies within their Precision portfolio. The ideal candidate will have a background in regulatory compliance, strong organizational skills, and experience with eTMF systems.