TMF Coordinator

TScan Therapeutics•Waltham, MA

About The Position

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.

Requirements

Bachelor’s degree in life sciences or a related field required
Minimum of 2-3 years of clinical research experience
Experience with TMF filing and eTMF platforms, EDC systems, and CTMS is preferred
Strong knowledge of ICH-GCP, FDA regulations, DIA TMF Reference Model, and clinical trial processes
Excellent organizational, communication, and problem-solving skills
Ability to manage multiple deliverables and priorities in a fast-paced environment
Ability to work independently and collaboratively within a cross-functional team environment

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