A company is looking for a Sr. TMF Reviewer.
Key Responsibilities :
Manage and perform TMF review of electronic Trial Master Files (eTMF) and related artifacts for clinical studies
Ensure the TMF is audit-ready by performing checks and tracking document completeness
Collaborate with study teams and participate in client audits and regulatory inspections
Required Qualifications :
Bachelor's Degree with a focus in Life Sciences or Business
Minimum of 6 years of experience in a clinical research environment
5+ years of experience with electronic records management systems
Clear understanding of GCP and ICH guidelines
Knowledge of regulatory and clinical document requirements
Senior • Lincoln, Nebraska, United States