Clinical Study Manager - Flexible Hours & Remote Options

Kanton Bern; Bern; Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Flexible working hours

Work from home

Training and development opportunities

Sports activities via Uni Sport

Job summary

The Department of Clinical Research (DCR) at the University of Bern invites applications for a Clinical Study Manager to start in 2027. This fixed-term position is initially for 3 years with a potential renewal in line with university regulations.

The successful candidate will coordinate complex clinical studies, manage budgets, ensure regulatory compliance, and lead study start-up activities while collaborating with internal teams and external partners.

Qualifications

• 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 responsibility for independently managing studies or substantial study components.
• Solid knowledge of ICH-GCP and clinical research regulations (HRA/ClinO); ISO 14155 / MDR a plus.
• Ability to manage multiple projects in a clinical research environment.
• Financial management and budget oversight experience.
• Strong organizational, problem-solving, and risk management skills.
• Excellent communication skills in English and German (written and oral).
• Ability to work independently while coordinating cross-functional teams.
• Experience in academic research environment is an asset.
• Familiarity with EDC and CDMS.

Responsibilities

• Plan, coordinate and drive complex clinical research projects, ensuring timelines, deliverables and milestones are met.
• Identify challenges and drive solutions in collaboration with internal and external stakeholders.
• Contribute to protocol development and budget planning, ensuring regulatory compliance and operational feasibility.
• Coordinate site feasibility assessments and site selection with investigators and stakeholders.
• Lead 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.
• Maintain Trial Master File for inspection readiness.
• Coordinate stakeholders including CEC, DSMB groups and process improvements.
• Vendor and CRO oversight.

Skills

Project management

Stakeholder collaboration

Regulatory compliance

Clinical trial coordination

Budget management

ICH-GCP knowledge

Team leadership

Data management

Education

Master's degree in life sciences/health

Certificate in clinical trial management (asset)

Tools

EDC

CDMS

Job description

The Department of Clinical Research (DCR) at the University of Bern invites applications for a Clinical Study Manager to start in 2027. This fixed-term position is initially for 3 years with a potential renewal in line with university regulations.

The successful candidate will coordinate complex clinical studies, manage budgets, ensure regulatory compliance, and lead study start-up activities while collaborating with internal teams and external partners.