PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. * Serve as medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines * Advise clients, project teams, sites, regulatory agencies and third-party vendors on medical matters * Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, patient narratives, and scientific presentations * Address safety issues across the trial from sites and the study team * Organize and lead clinical development advisory boards and safety monitoring boards * Ensure Study team compliance with FDA, EMEA, ICH
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