Sr. Specialist, Clinical Trials

Role: Senior Clinical Operations Lead managing planning, initiation, conduct, and close-out of domestic and global clinical studies, including CRO oversight and internal study management. Responsibilities: ensure compliance with FDA, ICH, EU directives, develop study reports, monitor project plans and metrics, lead or contribute to study team meetings, assist in recruitment, and document standard processes. Qualifications: BS/BA in a Scientific field with 4+ years of clinical trials or operations experience (CRO/vendor management preferred) or a Master’s degree with 2+ years’ relevant experience. Skills: strong knowledge of clinical drug development, GCP, FDA regulations, trial management, and project coordination; excellent communication, problem-solving, and data analysis skills; proficient in clinical operations tools and processes. High-Value: therapeutic focus on neurological, psychiatric, endocrine, and immunological disorders; involvement in mid- to late-phase clinical studies; experience with study start-up through close-out; ability to work cross-functionally and train team members. Work Setup: not specified; role likely hybrid or onsite based on typical clinical operations standards.