ITM Isotopen Technologien München AG

Monitoring and ensure proper study performance in accordance with GCP, internal SOPs and other applicable regulations Coordination and control of the study timelines and ensure on-time study conduct Development / Co-development, review and approval of study documentation (study protocols and amendments, IB, patient consent forms, case report forms, study manuals and study tools) Preparation of and participation in Scientific Advice Meetings with Health Authorities Coordination and oversight of CROs Participate in the ongoing and final review of study data and assessment of the impact of the data on the clinical development program Support logistics of the trial, to include budget tracking, IMP oversight Support clinical operations process initiatives and SOP development activities