Senior Clinical Trial Manager

TScan Therapeutics•Waltham, MA

2d•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 a Senior Clinical Trial Manager to support these studies. The ideal candidate should have relevant experience in oncology and cell therapy clinical studies and should thrive in a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will succeed in this role.

Requirements

Bachelor’s degree in a scientific or healthcare discipline preferred with at least 8-10 years of experience in a clinical research environment.
Cell Therapy and/or hematology experience preferred.
Experience leading Phase I-III oncology clinical trials.
Understanding of drug development, and familiarity with FDA and ICH GCP guidelines associated with conduct of clinical research.
Excellent interpersonal, written and spoken communication skills.
Ability to work in a flexible, matrix environment.
Good organizational skills and attention to detail.
Self-motivated with a willingness to learn.
Ability to take direction and manage multiple tasks.

Responsibilities

Lead all operational aspects of Phase I-III clinical trials from study start-up through study close-out.
Develop and maintain study operational plans, timelines, and key deliverables.
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and applicable regulatory requirements.
Lead cross-functional study team meetings and drive execution of study objectives.
Identify operational risks and develop mitigation strategies to maintain study timelines.
Track study milestones and proactively communicate study status, risks, and mitigation plans to management.
Support protocol development by providing operational input and reviewing study-related documents.
Participate in study feasibility assessments, country and site selection, and enrollment planning.
Lead investigator meetings, site initiation activities, and ongoing site engagement strategies.
Review enrollment metrics, site performance, and study quality metrics to identify trends and drive improvements.
Partner with CRAs to address site performance issues, protocol compliance, and enrollment challenges.
Lead vendor meetings, monitor vendor performance, review key performance indicators, and ensure contractual deliverables are met.
Review and approve vendor plans, study documentation, and operational deliverables as appropriate.
Support operational activities related to cell therapy studies, including manufacturing scheduling, apheresis coordination, chain of identity, chain of custody, and product logistics.
Ensure Trial Master File (TMF) documentation is complete, accurate, and inspection-ready throughout the study lifecycle.
Monitor TMF quality metrics and ensure timely filing of essential documents.
Support internal audits, quality reviews, regulatory inspections, and implementation of corrective and preventive actions.
Review study budgets, forecasts, purchase orders, invoices, and vendor expenses in collaboration with Clinical Operations leadership.
Contribute to development and continuous improvement of Clinical Operations processes, SOPs, work instructions, and study management tools.
Mentor junior team members and provide guidance to study team members as needed.
Foster collaborative relationships with investigators, study sites, vendors, and internal stakeholders.
Perform other duties as assigned to support Clinical Operations objectives.