h3Die UniBE ist renommiert. /h3 pBei uns profitieren Sie vom guten Ruf einer traditionsreichen Institution in der ganzen Welt. /p h3Your qualifications and skills /h3 ul liApply strong project management skills to plan, coordinate and drive complex clinical research projects, ensuring timelines, deliverables and milestones are met. /li liProactively identify challenges, take initiative and drive solutions in collaboration with internal and external stakeholders. /li liContribute to protocol development and budget planning, ensuring regulatory compliance and operational feasibility. /li liCoordinate and contribute to site feasibility assessments and site selection with investigators and relevant stakeholders /li liLead and coordinate study start-up, site activation and close-out independently. /li liPrepare and submit ethics and regulatory applications, amendments, safety reports and notifications. /li liContribute to CRF/eCRF design and data management planning. /li liTrain study teams in line with protocol, SOPs and ICH-GCP. /li liManage study contracts and budgets. /li liPrepare, review and quality-check essential documents and maintain the Trial Master File for inspection readiness. /li liCoordinate stakeholders, including CEC, DSMB groups, and contribute to continuous improvement of processes. /li liVendor and CRO oversight. /li /ul h3Requirements /h3 ul liMaster'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. /li liAt least 2 years relevant clinical studies experience, including demonstrated responsibility for independently managing studies or substantial study components. /li liSolid knowledge of ICH-GCP and the clinical research regulations (HRA/ClinO); ISO 14155 / MDR a plus. /li liDemonstrated ability to manage multiple projects in a clinical research environment. /li liFinancial management and budget oversight experience. /li liStrong organizational, problem-solving, and risk management skills. Careful and systematic approach to administrative tasks. /li liExcellent communication skills in English and German (written and oral). /li liAbility to work independently while effectively coordinating cross-functional teams. /li liExperience of working in academic research environment is an asset. /li liFamiliarity with clinical trial systems such as EDC, CDMS. /li /ul h3We offer /h3 ul liAn interesting and versatile role in a growing department, contributing to the successful development of the DCR. /li liAn international and dynamic environment with a motivated and diverse team, dedicated to high quality (research). /li liA good work-life balance thanks to flexible working hours and the possibility of working from home. /li liOpportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport' /li liSalary and comprehensive social benefits according to cantonal guidelines. /li /ul #J-18808-Ljbffr
Clinical Study Manager 80-100% Arbeitgeber: University of Bern
Die Universität Bern bietet eine herausragende Arbeitsumgebung für Wissenschaftliche Bibliothekarinnen und Bibliothekare, die sich für Open Science engagieren. Mit einer praxisorientierten Ausbildung und der Möglichkeit, den MAS-Studiengang an der Universität Zürich zu absolvieren, fördern wir nicht nur Ihre fachliche Entwicklung, sondern auch Ihre persönliche Entfaltung in einem dynamischen und unterstützenden Team. Unsere offene und kollaborative Kultur sowie die vielfältigen Projekte in der wissenschaftlichen Bibliotheksarbeit machen uns zu einem attraktiven Arbeitgeber für alle, die einen bedeutungsvollen Beitrag zur Forschung leisten möchten.
