Senior Clinical Trial Manager

About the role

TScan Therapeutics is a clinical-stage biotech company focused on developing innovative therapies using T cells and epitopes. We are currently seeking a Senior Clinical Trial Manager to support our groundbreaking research and clinical trials.

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.

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.

Qualifications

• PhD in a relevant field preferred.
• Experience in managing large-scale clinical trials.
• Strong understanding of clinical trial operations and regulatory requirements.
• Proven ability to lead and mentor teams.
• Excellent project management and organizational skills.

Skills

• Strong knowledge of ICH-GCP and FDA regulations.
• Experience with cell therapy and/or hematology clinical trials.
• Excellent communication and interpersonal skills.
• Ability to work in a fast-paced, dynamic environment.
• Strong problem-solving and decision-making abilities.

Benefits

TScan Therapeutics offers a comprehensive benefits package including health insurance, retirement plans, paid time off, and more. We are committed to fostering a diverse and inclusive workplace where everyone feels valued and supported.

Pay

The starting salary range for this role is $170,000 - $187,000 per year. Pay transparency is important to us, and individual compensation is determined based on qualifications, experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role.

Schedule

This role is full-time and based in our Boston office.

Contact

To apply, please submit your resume and cover letter detailing your relevant experience and why you are a great fit for this role. Please note that we do not accept unsolicited resumes from recruitment or staffing agencies. If you are contacted by an agency without a signed agreement, the resume will become their property.