Clinical Study Manager 80-100%

Die UniBE ist renommiert. Bei uns profitieren Sie vom guten Ruf einer traditionsreichen Institution in der ganzen Welt.

Your qualifications and skills

• 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.

We offer

• 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.

Bewerbung und Kontakt

Are you interested? If so, please send us your full application (including your CV, motivation letter, diplomas and references) to the HR Administration team ([email protected]) by 19. November 2026.