TMF Reviewer III
Fortrea(1 month ago)
Shanghai, ChinaOnsiteFull TimeSenior$143,291 - $193,213 (estimated)Clinical Operations
Apply NowAbout this role
The role manages ARC review and performs Trial Master File (TMF) review of electronic TMFs (Trial, Country, and Site artifacts) for clinical studies supporting sponsor services and internal Fortrea needs. The position ensures eTMFs are maintained in an audit-ready state, maps sponsor TMF indexes to Fortrea standards, and supports regulatory and audit preparedness. The role works closely with study teams and quality groups to support compliance with applicable guidelines.
Required Skills
- TMF Review
- Document Management
- Audit Readiness
- GCP
- ICH Guidelines
- Regulatory Knowledge
- Microsoft Office
- Adobe Acrobat
- Clinical Systems
- Interpersonal Skills
Qualifications
- Bachelor's Degree Life Sciences/Business
- Master's Degree Life Sciences/Business
- Equivalent Experience
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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