Clinical Study Manager 80-100%

pbDie UniBE ist renommiert. /b Bei uns profitieren Sie vom guten Ruf einer traditionsreichen Institution in der ganzen Welt. /ph3Clinical Study Manager 80-100% /h3pbArbeitsbeginn /b /pp oder nach Vereinbarung /ppbArbeitsverhältnis /b /ppbefristet /ppbInstitut / Arbeitsort /b /ppbThe Department of Clinical Research (DCR) /b /ppThe Department of Clinical Research (DCR) is an academic center and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals. It is comprised of a range of established academic research units, dedicated methodological divisions, a Clinical Investigation Unit, a Medical Data Science subunit established in 2025, and a Gender Medicine Unit scheduled for implementation in 2026. The DCR is a multidisciplinary institution that serves as a central body for expertise, innovation, strategic leadership, modern pedagogical approaches, and integrated infrastructure to support clinical research. It offers support to clinical researchers, along the entire research process from study design to implementation. DCR maintains close collaborative ties with the Medical Faculty of the University of Bern and the associated University Hospitals. The DCR is a national leader in Switzerland in the field of Patient and Public Involvement (PPI), which refers to the active involvement of patients and members of the public in the design, conduct, and dissemination of research. PPI helps ensure that research is relevant, transparent, and aligned with the needs and priorities of those it aims to benefit. We are looking for a Clinical Study Manager at the DCR to start in 2027. This is a fixed-term position for an initial period of 3 years with possibility of renewal, in accordance with the University of Bern's employment regulations. /ppbYour qualifications and skills /b /pulliApply strong project management skills to plan, coordinate and drive complex clinical research projects, ensuring timelines, deliverables and milestones are met. /liliProactively identify challenges, take initiative and drive solutions in collaboration with internal and external stakeholders. /liliContribute to protocol development and budget planning, ensuring regulatory compliance and operational feasibility. /liliCoordinate and contribute to site feasibility assessments and site selection with investigators and relevant stakeholders. /liliLead and coordinate study start-up, site activation and close-out independently. /liliPrepare and submit ethics and regulatory applications, amendments, safety reports and notifications. /liliContribute to CRF/eCRF design and data management planning. /liliTrain study teams in line with protocol, SOPs and ICH-GCP. /liliManage study contracts and budgets. /liliPrepare, review and quality-check essential documents and maintain the Trial Master File for inspection readiness. /liliCoordinate stakeholders, including CEC, DSMB groups, and contribute to continuous improvement of processes. /liliVendor and CRO oversight. /li /ulpbRequirements /b /pulliMaster's degree in a health or life science-related field; advanced degree or certificate in clinical trial management/coordination or regulatory affairs is an asset. /liliAt least 2 years relevant clinical studies experience, including demonstrated responsibility for independently managing studies or substantial study components. /liliSolid knowledge of ICH-GCP and the clinical research regulations (HRA/ClinO); ISO 14155 / MDR a plus. /liliDemonstrated ability to manage multiple projects in a clinical research environment. /liliFinancial management and budget oversight experience. /liliStrong organizational, problem-solving, and risk management skills. Careful and systematic approach to administrative tasks. /liliExcellent communication skills in English and German (written and oral). /liliAbility to work independently while effectively coordinating cross-functional teams. /liliExperience of working in academic research environment is an asset. /liliFamiliarity with clinical trial systems such as EDC, CDMS. /li /ulpbWe offer /b /pulliAn interesting and versatile role in a growing department, contributing to the successful development of the DCR. /liliAn international and dynamic environment with a motivated and diverse team, dedicated to high quality (research). /liliA good work-life balance thanks to flexible working hours and the possibility of working from home. /liliOpportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport' /liliSalary and comprehensive social benefits according to cantonal guidelines. /li /ulpbIhre Benefits /b /ppInternationales Renommee /ppGute Forschungsinfrastrukturen und internationales Netzwerk /ppKollaboratives Umfeld und ambitioniertes Team /ppIndividueller Karrieresupport /ppbArbeiten an der UniBE /b /ppDie Universität Bern bietet nicht nur spannende Aufgaben, sondern auch ein Umfeld, das Entwicklung, Vielfalt und Chancengleichheit aktiv fördert. Entdecken Sie, was uns als Arbeitgeberin auszeichnet und wie Sie bei uns weiterkommen. /ppbBewerbung und Kontakt /b /ppby 19. November 2026. /ppbFragen zur Stelle? /b /ppDr. Samantha Chan /ppbFragen zur Bewerbung? /b /ppAlexandra Briggeler /p #J-18808-Ljbffr