Clinical Study Specialist

Role: Clinical Study Specialist supporting trial management activities within Regeneron's clinical operations. Objectives include ensuring study progress from site activation through close-out, managing data and documentation, and maintaining stakeholder communication. Responsibilities encompass generating reports and metrics, tracking site activities, supporting document review, coordinating site relationships, and assisting with study close-out and vendor oversight. Requirements: Bachelor's degree with 2+ years of industry-related clinical experience, familiarity with trial systems and MS Office, understanding of medical terminology, and awareness of ICH/GCP guidelines. Basic knowledge of clinical drug development processes is expected. Preferred skills include proactive problem-solving, strong organizational ability, and experience with EDC, TMF, IVRS/IWRS systems. High-value specifics: role involves multi-site clinical trials, requiring detailed coordination of site activities, document management, and oversight of third-party vendors. The position is primarily on-site with hybrid flexibility, based in Armonk, NY, or Warren, NJ, and does not specify travel requirements.