Clinical Operations Manager (m/f/d)

Selection and interaction with external vendors (e.g. CRO, EDC providers) Auditing and monitoring of test centres, co-monitoring and auditing of Vendors Management and support in the submission of applications for studies and in the management and negotiation of study agreements Planning and implementation of national and international preclinical and clinical studies (after MDR, GCP, and relevant ICH guidelines, FDA Guidelines) in cooperation with our interdisciplinary research team and the departments Quality Management and Marketing Preparation of clinical trial plans, clinical study reports and scientific publications Ensuring regulatory quality requirements Preparation of templates and SOPs for clinical trials according to ISO 14155, MDR and FDA Guidelines Contact person for physicians and medical cooperation partners as well as non-medical staff

Successfully completed study of human medicine, human biology or similar science studies Multiannual experience in monitoring and submission of study documents Professional experience in the organisation and implementation of preclinical and clinical trials Good understanding of regulatory requirements in preclinical and clinical trials ideally for medical device studies Joy in working with people, data and figures in an international environment Embossed organizational and communicative skills Teamability and flexibility readiness to travel English knowledge and good German knowledge

Various offers in health management via cooking classes, health days, vaccination campaigns and fitness studio memberships E-car charging stations and free parking challenging tasks and a lot of self-responsibility Multicultural and international cooperation as well as the possibility of agile work Attractive monthly remuneration Flexible working hours and possibility to work hybrid Onboarding with introductory event and individual training plan as well as a wide internal and external training offer Social, social and resource-saving responsibility