The Document Management Associate (DMA) will support Trial Master File (TMF) activities for clinical teams. This role involves managing both electronic and paper TMFs according to project requirements, ICH GCP guidelines, local/global regulatory requirements, and Novotech/Client SOPs.
Minimum Qualifications & Experience
- At least 12 months of experience in a clinical research organization or equivalent.
- Practical experience in handling TMF activities, including Paper or electronic-TMF (eTMF).
- Background in the pharmaceutical, CRO, or healthcare industry is advantageous.
Responsibilities
- Receive, set up, track, and maintain TMFs (electronic or paper) according to ICH GCP and Novotech/Client SOPs.
- Use study systems (e.g., SharePoint) to ensure all study documents are filed appropriately throughout the study.
- Review each document for quality to ensure it meets Novotech essential document requirements.
- Provide reports on study document quality and collection practices and update the study team to ensure timely document collection.
- Ensure the TMF is always ‘inspection ready’ and trial master file documents are filed contemporaneously and timely, in accordance with project timelines.
- Adhere to TMF SOPs, KPIs, and relevant TMF process-supporting guidance.
- Perform interim eTMF exports/uploads for the sponsor or 3rd party if applicable.
- Run monthly reports to ensure file accuracy by performing file reviews.
- Prepare the TMF for delivery at study closeout.
