Clinical Scientist

1 month ago

Waltham, United States TScan Therapeutics Full time

**Position Summary**:
**Responsibilities**:

- Work alongside the Medical Monitor to support all TCR-T clinical trial activities related to the solid tumor program
- Support the authoring of clinical trial documents such as protocols, CRFs, ICFs, IBs, CSRs etc. as well as clinical sections of regulatory documents
- Work alongside the clinical operations teams and the CROs to ensure quality of clinical trial deliverables from trial planning and start up, through clinical trial conduct all the way to trial close up, database lock and CSR drafting.
- Collaborate and liaise with clinical sites to support overall clinical trial participant management, data review activities and facilitating issue resolution
- Support the development of data review plans and monitor clinical data for specific trends. Perform ongoing and timely clinical trial data review in the form of listings, tables, patient profiles and live clinical database
- Develop site and CRA protocol
- and product-related training materials and present these at SIV and Investigator meetings
- Conduct literature review, review clinical narratives, review coding listings, participate in SAE reconciliation

**Requirements**:

- Advanced degree in life sciences, healthcare, or other clinically relevant degree (MD, PhD, Pharm D, MS, RN, or another scientific field)
- 3-5 years of experience in Clinical Development Phase 1 - 3 oncology clinical trials within pharma/biotech
- Versed on GCP/ICH, study design, basic statistics, and clinical operations
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills
- Detail-oriented critical thinker, adept in problem-solving with a commitment to quality
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

**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?

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