Medical Monitor (Board-Certified Neurologist)

PSI Medical Monitors provide medical input to global clinical studies and advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters. Responsibilities include collaborating with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations. Review and analysis of clinical data is crucial to ensure the safety of study participants in clinical studies. The role requires ensuring data accuracy, completeness, and compliance with approved protocols. Additionally, the Medical Monitor will address safety issues across the study, review listings for coded events, participate in bid defense meetings, and assist in Pharmacovigilance activities. They will also identify program risks and implement mitigation strategies with Clinical Operations, organize and lead clinical development advisory boards and safety monitoring boards, and ensure Study team compliance with FDA, EMEA, ICH, and GCP guidelines. This role is on the frontline of medicine bringing new medications to patients.