Senior Clinical Trial Manager (CTM)

Role: Senior Clinical Trial Manager (Sr. CTM) responsible for overseeing the initiation, execution, and close-out of domestic and international clinical studies in a biopharma setting. Objectives include ensuring study quality, compliance with GCP and regulations, and fostering collaboration across functional teams. Core responsibilities encompass managing trial activities from protocol development to study reporting, overseeing regulatory submissions, and maintaining trial documentation, including TMF and trackers. The role also involves risk mitigation, process improvement, and ensuring inspection readiness. Qualifications include a Bachelor's in a scientific field with 5+ years of clinical trial management experience, solid understanding of ICH, GCP, and regulatory standards, and experience leading multidisciplinary teams. High-value specifics: involvement in early to late-phase CNS research, emphasizing data integrity and regulatory compliance. The position offers remote work with travel to Boston as needed, with a focus on cross-functional collaboration within clinical operations, quality, data management, and regulatory teams.