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Clinical Trial Manager/Senior Clinical Trial Manager - Waltham, United States - Tscanrx
Description
Clinical Trial Manager/Senior Clinical Trial Manager (CT30-2)LOCATION:
Waltham, MA
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 an Associate Director, Clinical Operations to oversee the execution of clinical in our hematological oncology program.
The ideal candidate should have relevant experience in oncology clinical studies, ideally with a cell therapy product, 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 the day-to-day internal and external clinical operations activities to support the hematological oncology program.
Manage external resources including consultants, CROs, central labs and other vendors to ensure study deliverables are met.
Lead the RFP and vendor evaluation process to identify and select new vendors.
Serve as the main point of contact with clinical sites to triage questions.
Contribute to the development of study documents including protocol amendments, study plans, ICFs, IBs, CRFs, etc.
Participate in data review with other core functions such as medical and data management.
Work with the finance team to track the study budget including reviewing and reconciling budget variances, tracking change orders, reviewing and approving invoices and forecasting future spend.
Develop and track project timelines and identify risks to the timelines and associated mitigation strategies.Work with the CRO and internal stakeholders to respond to IRB questions.
Work with the internal supply chain group to ensure delivery of leukopaks and drug product to and from the sites to TScan's internal GMP facility and forecast future drug needs.
Oversee site feasibility activities to identify new US and ex-US sites.Ensure studies are executed in compliance with internal SOPs and following ICH, GCP and other relevant guidances.
Build and maintain effective relationships with clinical sites, including triaging day to day issues, presenting at SIVs, etc.
Manage CTM and/or CTA direct reports.
REQUIREMENTS:
PhD in a scientific discipline or equivalent with 10+ years of related experience
8 -10 years of experience managing oncology clinical studies, preferably with experience in cell therapy studies
Excellent communication skills and ability to work in a flexible, matrix environment
Knowledge of drug discovery and development program management from Phase 1 – registrational studies
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.#J-18808-Ljbffr
