Senior Manager, Clinical Data

POSITION SUMMARY:

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 a Senior Clinical Data Manager to oversee data management activities across our studies in solid tumors and hematological tumors. The ideal candidate should have relevant experience in oncology clinical studies and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

REQUIREMENTS:

• Bachelor’s degree required
• 8 -10 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, CROs and consultants
• 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

• Oversee and be the primary point person for all internal and external data management activities
• 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 Validation Plans, etc)
• Oversee internal and external database cleaning, query resolution and database lock activities
• Support medical with SAE reconciliation and medical coding activities
• Develop data transfer agreements with third parties
• Generate ad hoc data listings and patient profiles 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