Clinical Study Manager 80-100%

University of Bern; Bern; Hybrid; CHF 90,000 - 130,000; Full time

Benefits offered by this job

Flexible Arbeitszeiten

Home-Office möglich

Fortbildungsmöglichkeiten

Uni Sport-Angebot

Sozialleistungen gemäß kantonalen Vorg

Salary and comprehensive social ben

Job summary

Die Universität Bern sucht eine erfahrene Fachkraft zur Koordination klinischer Studien. Sie steuern komplexe Projekte, arbeiten eng mit internen und externen Stakeholdern zusammen und sichern Budgets, Fristen sowie regulatorische Compliance.

Sie bringen mind. 2 Jahre Studienerfahrung, ICH-GCP-Kenntnisse und hervorragende Deutsch- und Englischkenntnisse mit. Flexible Arbeitszeiten und Home-Office-Optionen ergänzen das Angebot.

Qualifications

• Mindestens 2 Jahre relevante klinische Studienerfahrung, inkl. eigenständiger Studien-/Teilprojektführung.
• Fundierte Kenntnisse zu ICH-GCP und klinischen Studienregularien (HRA/ClinO).
• Erfahrung in Budget- und Ressourcensteuerung sowie Risiko-Management.
• Gute Englisch- und Deutschkenntnisse in Wort und Schrift.

Responsibilities

• Planen, koordinieren und steuern Sie komplexe klinische Studienprojekte.
• Kontinuierliche Identifikation von Herausforderungen und proaktive Lösungsinitiativen.
• Unterstützen Protokoll-Entwicklung, Budgetplanung und regulatorische Einreichungen.
• Koordination von Site-Feasibility, Site-Auswahl und Start-up-Aktivitäten.
• Leitung von Studien-Start, Site Activation und Close-out.
• Erstellung, Prüfung und Qualitätskontrolle wesentlicher Dokumente; Trial Master File pflegen.

Skills

Projektmanagement

Stakeholder-Koordination

Budgetplanung

Regulatorische Anträge

Datenmanagement

Studien-Start-Up

Protokoll-Entwicklung

Ethik- und Compliance

Vertrags- und CRO-Überwachung

Team-Training

Dokumentenmanagement

Education

Masterabschluss in Gesundheits- oder Lebenswissenschaften

Zusatzqualifikation in klinischen Studien/Regulatory Affairs (Vorteil)

Tools

EDC/CDMS

Job description

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.