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Clinical Trial Manager (f/m/d)
Garching bei München
Aktualität: 27.09.2023


27.09.2023, ITM Isotope Technologies Munich SE
Garching bei München
Clinical Trial Manager (f/m/d)
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
Graduation from a German or foreign institution of higher education (University level) preferably in Life Science, Chemistry, Biology or Pharmacy Several years of professional experience in clinical research and the management of (international) clinical trials, with emphasis on the management of multinational, phase III oncology studies Sound knowledge of FDA, EMA and ICH / GCP regulations and guidelines Solid background in oncology and strong interest in new therapies Independent, communicative, proactive, goal-oriented and reliable work approach Fluent in German and English, both written and spoken Willingness to travel internationally



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Clinical Trial Manager (f/m/d) 27.09.2023 Garching bei München