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Job Description
Your responsibilities will be
- Maintain TMF documentation in accordance with ICH-GCP, regulatory requirements, and internal SOPs
- Perform quality control (QC) checks and TMF reviews to ensure completeness and accuracy
- Collaborate with clinical research associates, project managers, and other team members to collect and reconcile documentation
- Assist in TMF metrics reporting and contribute to continuous improvement initiatives
- Archival of the TMF for clinical trials
- May contribute to non-trial projects as assigned