Clinical Study Manager (m/f/d)

For the Research and Basic Technologies Department of our Tübingen location, we are looking for a

Clinical Study Manager (m/f/d)

Your Responsibilities

• Plan and implement preclinical and clinical studies; prepare clinical investigation plans, clinical study reports and scientific publications
• Select and interact with external vendors (e.g. CRO, EDC providers)
• Audit and monitor study centers, co-monitor and audit vendors
• Carry out national and international preclinical and clinical studies according to MPG, GCP, as well as relevant ICH and FDA guidelines. This will be done in cooperation with our interdisciplinary research team and the departments of quality management and marketing
• Ensure that regulatory quality requirements are satisfied
• Creation of templates and SOPs for clinical trials according to ISO 14155, MDR and FDA guidelines, among others
• Act as contact person for investigators, medical cooperation partners and non-medical staff

Your Skills

• Successful completion of studies in human medicine, human biology or a similar scientific discipline
• Professional experience in organizing and conducting preclinical and clinical studies
• Good understanding of regulatory requirements in the context of preclinical and clinical studies, ideally for medical device studies
• You enjoy working with people, data and numbers in an international environment
• Strong organizational and communication skills
• You enjoy teamwork and flexibility
• Prepared to travel
• Fluent business English and German