- Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial.
- Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team.
- Triage CRO and clinical site questions.
- In conjunction with the legal team, facilitate the development of clinical trial agreements and other relevant documents.
- Coordinate and lead study team meetings and update timelines and milestones as needed.
- Train team members and site staff, including vendors, as needed.
- Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
- Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors
- Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies.
- BS/BA in scientific or healthcare discipline with 4-7 years' experience in clinical trial management at a CRO, pharmaceutical/biotechnology company
- Experience with complex therapeutic platforms.
- Strong Oncology and Cell Therapy clinical trials.
- Strong computer skills, including Excel, Word, Outlook, and PowerPoint
- Knowledge of GCP guidelines and demonstrated experience supporting clinical trials
- Excellent interpersonal skills and ability to build strong professional relationships internally and externally
- Strong analytical and problem-solving skills
- Strong attention to detail in drafting materials, establishing priorities, scheduling, and meeting deadlines
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Clinical Trial Manager/Senior Clinical Trial Manager - Waltham, United States - TScan Therapeutics
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 Clinical Trial Associate to join our Clinical Operations team to support the execution of clinical studies across our hematological and solid tumor programs. The ideal candidate should have experience in supporting the execution of oncology clinical studies as well as a working knowledge of ICH GCP regulations. The candidate should a enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
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.
