Clinical Monitoring Lead

Our Boston area client is seeking a Contract Clinical Monitoring Lead to support end‑to‑end execution of clinical trials, with a focus on rare disease and neurology. This position oversees site compliance, drives enrollment, and ensures high‑quality data delivery while partnering with cross‑functional teams and external vendors.Key ResponsibilitiesLead site monitoring to ensure compliance with protocols, GCP, FDA regulations, and IRB/EC requirements.Serve as primary site liaison and conduct qualification, initiation, monitoring, and close‑out visits.Perform co‑monitoring with CRO CRAs and produce timely, high‑quality visit reports.Contribute to protocol development, informed consent forms, CRFs, study plans, APRs, and CSRs.Maintain data integrity through trend review, audit support, and corrective action oversight.Support SOP updates, TMF documentation, and inspection readiness.Drive enrollment and identify site‑level challenges.Assist with vendor setup and ongoing vendor management.Support data review, cleaning, and database lock activities.Travel requirement: 50–75%.Required Qualifications5+ years of clinical research experience, including pivotal rare disease or neurology trials.Experience setting up and managing clinical study vendors.Background supporting audits and inspection readiness.Strong knowledge of GCP, FDA regulations, and IRB processes.Excellent project management and communication skills.Proficiency with Microsoft Office, EDC systems, and eTMF platforms.Experience working with investigators and clinical staff; familiarity with medical terminology.Ability and willingness to travel.