Clinical Data Manager

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     Clinical Data Manager Department: 30 - Clinical Location: Waltham, MA START YOUR APPLICATION TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for looking for a Clinical Data Manager to support data management activities across our studies in solid tumors and hematological tumors. Reporting to our Senior Clinical Data Manager the ideal candidate should have relevant experience in leading internal and external data management activities in oncology clinical studies and enjoy fast-paced, collaborative, and vibrant culture. A team player with a sense of urgency will thrive in this role. Responsibilities: Lead all study specific data management activities with internal and external stakeholders. Work with CROs in designing and updating CRFs, EDC systems and edit checks Develop data management documents to support study execution (e.g. Data Management Plans, eCRF completion guidelines, Data Review Plans, etc) Oversee internal and external database cleaning, query resolution and database lock activities Support SAE reconciliation and medical coding activities Develop data transfer agreements with third parties Generate ad hoc data listings to support medical, clinical operations and translational research activities (e.g. listings to support Safety Review Meetings or Dose Escalation Meetings, consolidating translational data sets, etc Requirements: Bachelor�s degree required 5 -8 years of experience managing data management activities to support oncology clinical studies Excellent communication skills and ability to work in a flexible, matrix environment Experience managing external resources such as vendors and CROs Advanced working knowledge of all relevant guidelines, including ICH, GCP, and other relevant FDA guidance�s Excellent oral and written business communication skills Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders About TScan: TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan�s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women�s Hospital and Harvard Medical School. TScan�s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases. Do YOU have the anatomy of a TScanner? Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are 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...