Trial Master File Specialist (TMFS)

TMF Specialist supports the management of project-specific Trial Master File (TMF) through the quality check, maintenance and filing of clinical records.

• Assists with set up and maintenance of the Trial Master File (TMF) for assigned projects 
• Serves as main point of contact for all TMF-related activities for assigned projects.
• Processing and indexing of project documents for the TMF in accordance with project-specific guidelines and relevant SOPs.
• Ensures that all project documents are maintained in accordance with relevant SOPs.
• Assists in TMF closure, transfer and archiving 
• Tracks and performs quality check of documents using internal systems and ALCOA+ principles.
• Attends project team meetings and training sessions on request and according to project and/or Sponsor requirements.
• Manages preparations for study specific audits, attends in-house project audits if required, takes part in analysis of received audit report.
• If requested by the PM/CTM, the TMF Specialist can also propose and oversee completion of Corrective and Preventative Action Plan with respect to all TMF aspects of the project.