About the role
TMF Coordinator - Careers At TScan Therapeutics --> Career Opportunities with TScan Therapeutics A great place to work. Careers At TScan Therapeutics Current job opportunities are posted here as they become available. --> --> --> Back To Openings TMF Coordinator Department: 30 - Clinical Location: Waltham, MA START YOUR APPLICATION TScan Therapeutics is a startup biotech company seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. To fuel our discovery efforts, we have established tissue collection research studies to identify the targets of T cells in cancer and autoimmune diseases as well as solid tumor and heme malignancy studies. We are looking for a TMF Coordinator to support these studies. The ideal candidate should have relevant experience in oncology clinical studies and should thrive in a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will succeed in this role.
Responsibilities: Support day-to-day Trial Master File (TMF) activities for clinical studies, which includes uploading, classifying, and quality control of documents within the eTMF system Serve as TMF point of contact for clinical studies, answering process-related questions while providing training and ongoing support to internal personnel to ensure proper TMF filing Ongoing maintenance and management of the TMF for clinical studies Maintain TMF-related trackers, logs, plans and other study documentation, as required Generate metrics for supporting TMF completeness, accuracy and quality Stay up to date with industry trends and regulatory
requirements related to TMF management and best documentation practices Conduct regular reviews of the TMF to ensure completeness, accuracy, and compliance with standards Serve as a primary liaison between TMF service providers and internal TScan team, building strong relationships with external vendors Collaborate with cross-functional teams (Clinical Operations, Data Management, Medical, Safety, Regulatory, Clinical Quality) to support TMF expectations and timelines Assist in the development and maintenance of study related documents to ensure continued alignment with the TMF filing process Identify opportunities for process improvement or increased efficiency Support audit and inspection readiness activities and participate in regulatory inspections as needed May support other ad hoc clinical operations study activities and administrative tasks, as needed