Senior Clinical Trial Manager

Role: Senior Clinical Trial Manager overseeing global pivotal studies in rare pediatric neurological diseases, with a focus on RNA-based therapeutics. Responsibilities include leading cross-functional study teams, managing CRO/vendor oversight, study start-up, feasibility, site selection, and ensuring compliance with GCP, timelines, and budgets. The role involves development and review of study protocols, operational plans, risk mitigation, vendor qualification, and data review coordination. Qualifications: Bachelor’s degree in a scientific or healthcare field; minimum of 8 years’ experience leading global clinical trials within biotech/pharma or CROs; experience with pediatric rare diseases, neurology, dose escalation studies, and safety monitoring committees is highly desirable. Necessary skills include in-depth knowledge of ICH-GCP, drug development processes, vendor oversight, and project management tools. High-value specifics: focus on rare CNS diseases, biologics/antisense modalities, Phase 3 trials, and global vendor coordination. The role reports to senior leadership, involves remote work with approximately 15% travel, and is based in Bedford, MA (transitioning to Waltham, MA). The position emphasizes collaboration across clinical, CMC, and vendor teams with adherence to regulatory standards and quality metrics.