Head of Clinical Research Support Unit (CRSU) / Clinical Research in OWL (m/f/d)

Conception, construction and further development of the CRSU and the associated service and consulting services Building and optimizing processes, governance structures and modern controlling and reporting Administrative and personnel management of the growing functional areas including resource and budget planning Consulting and support in the planning, implementation and completion of investigator-initiated clinical studies (IITs) Responsibility for regulatory issues and monitoring of approval processes Cooperation with authorities, ethics committees and internal and external partners Establishing and further developing cooperation structures with research partners Working and consulting in the fields of Regulatorics, Quality Management, Study Management, Pharmacovigilance and Monitoring Representation of the site in national and international networks

Insufficient, completed academic studies (University Diploma/Master) of human medicine or other relevant scientific or health studies Insufficient completed doctorate Multiannual extensive professional experience in the written field, e.g. in the pharmaceutical industry or academic research Knowledge of partial disciplines of clinical research (including project management, regulatory, quality management, data management, monitoring and pharmacovigilance) Professional knowledge of legal regulations and guidelines such as ICH-GCP, AMG, MPDG and CTR Experience with study-specific EU portals and their access and rights management Experience in the standardized risk assessment, Vendorqualification and the sponsor Oversight Very good knowledge of German and English in word and writing Management competence

Unlimited full-time permanent employment Attractive remuneration according to qualification and experience High design space for building a central research unit Flexible working hours and possibility for mobile work Safe workplace in an innovative scientific environment Extensive internal and external training opportunities Additional service Modern working conditions and collegial corporate culture Compatibility of family and occupation