Senior Clinical Trial Manager
$170,000–$187,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead all operational aspects of Phase I–III oncology clinical trials from start-up through close-out, developing study plans, timelines, and key deliverables while ensuring compliance with ICH-GCP, FDA regulations, and company SOPs. Drive execution by leading cross-functional meetings, identifying risks, and communicating status to management. Manage site initiation, investigator engagement, and enrollment planning, partnering with CRAs to resolve performance issues and monitor vendor performance and contractual deliverables. Support cell therapy studies including manufacturing scheduling, apheresis coordination, and chain of custody, while maintaining inspection-ready Trial Master Files and overseeing budgets and expenses. Mentor junior team members and contribute to the continuous improvement of Clinical Operations processes and study management tools.
Required Qualifications
- Bachelor's degree in a scientific or healthcare discipline
- 8-10 years of experience in a clinical research environment
- Cell Therapy and/or hematology experience
- Experience leading Phase I-III oncology clinical trials
- Understanding of drug development
- 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
Desired Qualifications
- Bachelor's degree in a scientific or healthcare discipline preferred
- Cell Therapy and/or hematology experience preferred
- Experience leading Phase I-III oncology clinical trials
- Understanding of drug development
- 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
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