Senior Clinical Trial Manager (CTM)

Role: Senior Clinical Trial Manager (Sr. CTM) responsible for overseeing domestic and international clinical study management from initiation to close-out. Objectives include ensuring trial quality, compliance with GCP and regulations, and fostering collaboration with key stakeholders. Responsibilities encompass study planning, feasibility, start-up, contract and budget oversight, data support, and regulatory submissions, with an emphasis on process improvement and risk mitigation. Qualifications: Bachelor's in a scientific field with 5+ years' experience managing clinical trials, deep understanding of clinical operations, GCP, and cross-functional teamwork in a biopharma setting. High-value specifics include clinical trial management within a biopharma company focused on CNS disorders, with responsibilities spanning protocol development, regulatory documentation, and inspection readiness. Experience with international trial coordination, regulatory submissions, and process optimization is preferred. The role may be remote with travel to the Boston area as needed.