Senior Manager, Clinical Data

1 month ago

Waltham, United States TScan Therapeutics Full time
Job DescriptionJob Description

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.

Responsibilities:

  • 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

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

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

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.

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