Head of the Clinical Trials Unit (m/f/d)

As a university hospital for maximum care with a capacity of around 1,300 beds, we provide over 8,000 employees in 30 clinics, 27 institutes and specialist centers every year with 225,000 patients. Our house offers medical care, state-of-the-art diagnostics and comprehensive therapy with the highest international standard. In addition, there is an extensive range of services in research and teaching at an internationally competitive level. In order to improve the compatibility of work and family life, the university hospital offers a day-care facility for the children of the employees. Our family and health department assists you in finding further childcare facilities, advises to care for family members and determines internal and external services on request. During the holidays we offer a varied program for the children who are subject to school. In addition, the University Hospital Essen offers its employees good training opportunities, inexpensive parking facilities in the car parks, discounted meals in the canteen and an annual operating festival. Head of Department of Clinical Studies (m/w/d) Department of Staff Clinical Studies Position of non-scientific body Job ID 13493 Admission as soon as possible full-time; 44 hours Contract type Unlimited Remuneration We offer you a performance-based compensation with an out-of-tariff contract.

The Office for Clinical Studies of the Management Board of the University Medicine Essen (UME) is reestablished as a successor structure of UME Studienzentrum GmbH. It shall coordinate all tasks of planning, carrying out and monitoring clinical trials according to AMG or MDR/MPDG. This will include both academic clinical trials (IITs) under the sponsorship of the University Medicine Essen or other academic institutions as well as contract research including industrial sponsorship studies (CRO function). In addition, all tasks of the sponsor quality assurance are to be taken over. The Office for Clinical Studies will be available to doctors and scientists from the University Medicine Essen as a comprehensive support structure. In this role you will be given the opportunity to actively participate in the design and development of the staff. You advise the medical director, other board areas, hospital and institute management as well as administrative units in all regulatory and administrative issues of clinical trials. Core tasks of the staff-station line: Strategic orientation: building and coordinating a central infrastructure for regulatory and administrative support for clinical trials and acquisition of new clinical study projects Management & Quality: Responsibility for conducting clinical trials (phase I-IV) in accordance with the applicable legal requirements (EU regulations, ICH GCP, National Laws). Development and implementation of uniform processes and standards for study management, quality assurance and documentation. Monitoring all processes during the takeover of sponsor responsibility by the University Medicine Essen, carrying out mandatory consultations of the Studienleitung before sponsor acceptance. Communication with internal and external project partners. Implementation of sponsorship and audit bodies. Correspondence with the approval and supervisory authorities. Monitoring and follow-up of official inspections. Team management: Head of the associated study staff (Study Nurses, CRAs, PMs). Close cooperation with all clinics and institutes as well as internal and external stakeholders to promote and support clinical studies Administrative management: Budget planning and contract design. Coordination with the other University Hospital in NRW to bundle resources and harmonize procedures Cooperation in various bodies: Representation of the UME in various bodies (e.g. PPS-N, MFT)

Complete medical studies or comparable university studies, ideally with doctoral studies Multiannual professional and leadership experience in Clinical Trial Management, preferably in a Clinical Research Organisation (CRO), in an academic study centre or in a PPS/ZKS Multiannual experience in the planning and operational implementation of national/international clinical studies, as well as in the field of sponsor quality assurance and associated process processes. Experience in the auditing and inspection of clinical trials and the preparation of SOPs Ideally experience as a member of a test team Knowledge of regulatory requirements (CTR, AMG, MDR/MPDG, ICH-GCP, etc.) and cooperation with ethics committees, authorities and clinical testing centres Experience in coordination across institutional boundaries and dealing with pharmaceutical and medical technology companies Founded, multiannual experience in committee work, ideally through active cooperation in or directed by an Ethics Commission, and experience in evaluating complex technical questions Ability to target and solution-oriented processing of complex problems Self-employed and structured working methods, high quality awareness, self-responsibility as well as strong team skills Embossed organisational and communicative skills and a high degree of self-initiative and flexibility Safe handling of popular MS Office products and study management tools Very good knowledge of German and English in word and writing

Varied, versatile and responsible tasks in a dynamic and interdisciplinary team The opportunity to actively contribute to the development and development of central structures and processes A pleasant working climate Modern workplace with the possibility to work proportionally in the home office A secure workplace in the public service of NRW 30 days holiday in the calendar year (at a 5-day week) Interdisciplinary work with colleagues from other fields Working with modern equipment and certified quality standards Family-friendly corporate culture, e.g. a children's day-care facility, a holiday programme for school-aged children, advice and support by the family & health department in all situations of life Various possibilities for continuing and continuing training, e.g. in the Academy of Education of the UK Essen Health management, e.g. occupational integration management, vaccination, promotion of sports activities Attractive additional services, e.g. discounted canteens, community events, residential areas Conditions The UK Food aims to increase the proportion of women in areas where women are underrepresented. You are asked to apply and are taken into account in the sense of the LGG with the same qualification. Disabled applicants/applicants and equivalents in § 2 para. 3 SGB IX are preferably taken into account with the same suitability. In principle, the agency is also suitable for parttime workers. A certificate in accordance with §23a Infection Protection Act (IfSG) on vaccination and sero status related to Masern is required. .