ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are 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/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
What we are looking for:
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
What we offer:
A modern workplace and exciting opportunities in an evolving and fast-growing company
Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
A collegial corporate culture and short communication channels
Flexible working hours with an attractive salary package and diverse corporate benefits
Home office possibilities
At ITM, we work together towards one common goal – the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this, we create opportunities that are as unique as our team. We encourage diversity and inclusion – the input of our multicultural employees makes us who we are.
Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than «maybe».
Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?
Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.
Contact for your application:
ITM Isotope Technologies Munich SE
85748 Garching / Munich, Germany
Phone: +49 89 3298986-1706
Contact: Elisabeth von der Grün
For more information please visit: www.itm-radiopharma.com