The TMF Specialist is a cross-department role and responsible for project document management activities, quality control and the archival of clinical trial records for both paper (pTMF) and electronic Trial Master File (eTMF) within CTMS.
- Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures.
- Be familiar with CTMS and eTMF usage and structure, including the attribute of documents. Communicate with CTMS vendor for problem solving if necessary
- Be familiar with GCP, GDP, & regulatory requirement for clinical trial documentation.
- Perform TMF services to internal clients (cross departments) in accordance to Standard Operating Procedures (SOPs).
- Ensure the TMF naming convention following the A2TW standard naming convention or project specific naming convention mentioned in the TMF Plan.
- Perform the TMF document image and content QC and complete the necessary processes in eTMF periodically in accordance with project, organizational, and regulatory requirements.
- Generate QC reports and coordinate the document integrity of TMF cross-functionally.
- May assist in the training and onboarding of new team members on eTMF usage or TMF processes. Control the CTMS user headcounts within the budget.
- Archive the study documentation and return the eTMF to sponsor, as directed.
- Report all document collection and tracking issues to Project Manager and/or project team on a regular basis.
- Participates in internal and external team meetings, taking minutes and providing status updates as required.