Clinical Study Manager 80-100%

Die UniBE ist renommiert.
Bei uns profitieren Sie vom guten Ruf einer traditionsreichen Institution in der ganzen Welt. • Apply strong project management skills to plan, coordinate and drive complex clinical research projects, ensuring timelines, deliverables and milestones are met.
• Proactively identify challenges, take initiative and drive solutions in collaboration with internal and external stakeholders.
• Contribute to protocol development and budget planning, ensuring regulatory compliance and operational feasibility.
• Coordinate and contribute to site feasibility assessments and site selection with investigators and relevant stakeholders
• Lead and coordinate study start-up, site activation and close-out independently.
• Prepare and submit ethics and regulatory applications, amendments, safety reports and notifications.
• Contribute to CRF/eCRF design and data management planning.
• Train study teams in line with protocol, SOPs and ICH-GCP.
• Manage study contracts and budgets.
• Prepare, review and quality-check essential documents and maintain the Trial Master File for inspection readiness.
• Coordinate stakeholders, including CEC, DSMB groups, and contribute to continuous improvement of processes.
• Vendor and CRO oversight.

Requirements
• Master'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.
• At least 2 years relevant clinical studies experience, including demonstrated responsibility for independently managing studies or substantial study components.
• Solid knowledge of ICH-GCP and the clinical research regulations (HRA/ClinO); ISO 14155 / MDR a plus.
• Demonstrated ability to manage multiple projects in a clinical research environment.
• Financial management and budget oversight experience.
• Strong organizational, problem-solving, and risk management skills. Careful and systematic approach to administrative tasks.
• Excellent communication skills in English and German (written and oral).
• Ability to work independently while effectively coordinating cross-functional teams.
• Experience of working in academic research environment is an asset.
• Familiarity with clinical trial systems such as EDC, CDMS. • An interesting and versatile role in a growing department, contributing to the successful development of the DCR.
• An international and dynamic environment with a motivated and diverse team, dedicated to high quality (research).
• A good work-life balance thanks to flexible working hours and the possibility of working from home.
• Opportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport'
• Salary and comprehensive social benefits according to cantonal guidelines. Internationales Renommee Gute Forschungsinfrastrukturen und internationales Netzwerk Kollaboratives Umfeld und ambitioniertes Team Individueller Karrieresupport