TMF Coordinator

Job Description

Job Description

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

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

Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.

EEO Statement
TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

Pay Range: $87,500 - $93,000

Pay Transparency
TScan Therapeutics’ pay ranges are established based on external market data from third-party compensation surveys and our internal benchmarking. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Individual compensation within this range is commensurate with a candidate’s specific qualifications, including education, overall experience, relevant experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role.

Recruitment & Staffing Agencies
TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.