For the Research and Basic Technologies Department of our Tübingen location, we are looking for a
Clinical Operations Manager (m/f/d)
Your Responsibilities
- Select and interact with external vendors (e.g. CRO, EDC providers)
- Monitor, co-monitor and audit study centers
- Lead and support study submissions and study agreements management and negotiation
- Plan and implement national & international preclinical and clinical studies according to MDR, GCP as well as relevant ICH and FDA guidelines etc. in close interaction with; our interdisciplinary research team and the departments of quality management and marketing
- Prepare clinical investigation plans, clinical study reports and scientific publications
- 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
- Several years of experience in Monitoring and Study Submissions
- 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 clinical 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
Benefits:
- Wide range of health management services, including cooking classes, health days, vaccination campaigns and fitness studio memberships
- Electric car charging stations and free parking
- Challenging tasks and a lot of personal responsibility
- Multicultural and international collaboration and the opportunity for agile working
- Attractive monthly remuneration
- Flexible working hours and the opportunity to work a hybrid schedule
- Onboarding with an introductory event and an individual induction plan as well as a wide range of internal and external training courses
- Social, societal and environmental responsibility
Are you interested?
If so, we look forward to receiving your application, including your salary expectations and the earliest possible starting date. Please apply via our career portal.