Senior Clinical Trial Manager
HybridWaltham, Massachusetts, United States
Job Summary
Lead operational execution of post-market clinical studies, registries, and observational research programs supporting the LumiSystem platform. Serve as the primary operational lead for study start-up, site activation, investigator engagement, and cross-functional study execution. Drive site selection, budget development, contract negotiation, and IRB readiness while managing investigator communications and maintaining strong collaborative relationships. Partner with CRAs to ensure effective site monitoring, review findings for protocol deviations, and oversee Clinical Monitoring Plans. Maintain oversight of study TMF completeness, coordinate inspection readiness activities, and prepare status updates for leadership. Lead recurring study team meetings, facilitate issue escalations, and develop training materials for site initiation visits.
Required Qualifications
- Bachelor's degree in Life Sciences, Nursing, Public Health, or related field
- Strong knowledge of ICH-GCP, FDA regulations, clinical trial operations, post-market research, registry studies, and site management
- Experience with study start-up, site activation, contracting, and IRB processes
- Experience coordinating CRAs and cross-functional study teams
- Excellent communication, organizational, and project management skills
Desired Qualifications
- Advanced degree such as MPH, MS, RN, PharmD, or equivalent
- Combination product experience or medical device experience
- Oncology experience
- Experience managing registries and post-market surveillance studies
- Experience with EDC systems, eTMFs, and inspection readiness activities
- Experience building study training materials and investigator-facing materials
- Experience working in small-company or fast-paced clinical operations environments
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.