Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Summary of Essential Functions: Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers,
Job Description Summarized Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and