TMF Reviewer III
Fortrea(1 month ago)
About this role
The TMF Reviewer manages ARC review and performs Trial Master File (TMF) reviews of electronic Trial Master Files (eTMF), covering trial, country, and site artifacts to support sponsor service contracts and Fortrea business needs. The role ensures TMF audit readiness, aligns sponsor TMF indices with Fortrea standards, and supports QA, audits, and regulatory inspections. It collaborates with study teams and quality groups across clinical studies and phases to maintain regulatory compliance.
Required Skills
- eTMF Management
- TMF Review
- Audit Readiness
- Document Control
- GCP Knowledge
- ICH Knowledge
- Regulatory Knowledge
- Quality Assurance
- Microsoft Office
- Adobe Acrobat
+2 more
Qualifications
- Bachelor’s Degree in Life Sciences or Business
- Master’s Degree in Life Sciences or Business (Preferred)
About Fortrea
fortrea.comFortrea, a leading CRO, advancing clinical trials through patient-focused clinical solutions that accelerate clinical development, drive trial success, and bring innovative therapies to those who need them most.
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