Clinical Data Manager

TScan Therapeutics•Waltham, MA

3d•Hybrid

About The Position

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.

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

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)