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 Responsibilities

• Lead 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 Qualifications

• 5+ 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.