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Clinical trial manager (f/m)

Garching bei München
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Clinical Trial Manager
Inserat online seit: 2 Februar
Beschreibung

ITG Isotope Technologies Garching GmbH ITG is a subsidiary of ITM Isotopen Technologien München AG, a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are directly located in the heart of the research center of the Technical University of Munich (TUM). We would like to fill the following vacancy as soon as possible: Clinical Trial Manager (f/m) Your Role: 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 CRO coordination and oversight Participate in the ongoing and final review of study data and assessment of the impact of the data to the clinical development program Support logistics of the trial Inhouse interface to the Supply Chain Management team Your Profile: You have successfully completed your scientific degree (for example in Chemistry, Biology, Pharmacy or Medicine) You already have several years of professional experience in clinical research and the management of (inter-national) clinical trials Sound knowledge of FDA, EMA and ICH / GCP regulations and guidelines Ideally you have a solid background in oncology and are very interested in new therapies You are naturally communicative and can work independently, proactively and goal-oriented You are fluent in English and have a good command of German language You are willing to undertake international travel (approximately 20 to 30 % of your time) What we offer: A modern workplace and exciting opportunities in the development of technologies with a secure future Cross-border intercultural cooperation and short communication channels A collegial corporate culture An attractive salary package and diverse corporate benefits Applications are accepted either in German or English language. Do you feel addressed? Then we offer you an innovative work environment in a highly committed team with the opportunity to actively shape the future of ITG. Please send us your detailed application documents stating the earliest starting date and your salary expectation. ITG Isotope Technologies Garching GmbH Human Resources Schleißheimer Straße 91 a 85748 Garching, Germany E-Mail:

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