Clinical Study Manager 80-100%

Kanton Bern; Bern; Hybride; CHF 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Flexible working hours

Work from home

Training and development opportunities

Sports activities via Uni Sport

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Project management

Stakeholder collaboration

Regulatory compliance

Clinical trial coordination

Budget management

ICH-GCP knowledge

Team leadership

Data management

Formation

Master's degree in life sciences/health

Certificate in clinical trial management (asset)

Outils

EDC

CDMS

Description du poste

The Department of Clinical Research (DCR)

The Department of Clinical Research (DCR) is an academic center and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals. It is comprised of a range of established academic research units, dedicated methodological divisions, a Clinical Investigation Unit, a Medical Data Science subunit established in 2025, and a Gender Medicine Unit scheduled for implementation in 2026.

The DCR is a multidisciplinary institution that serves as a central body for expertise, innovation, strategic leadership, modern pedagogical approaches, and integrated infrastructure to support clinical research. It offers support to clinical researchers, along the entire research process from study design to implementation. DCR maintains close collaborative ties with the Medical Faculty of the University of Bern and the associated University Hospitals.

The DCR is a national leader in Switzerland in the field of Patient and Public Involvement (PPI), which refers to the active involvement of patients and members of the public in the design, conduct, and dissemination of research. PPI helps ensure that research is relevant, transparent, and aligned with the needs and priorities of those it aims to benefit.

We are looking for a Clinical Study Manager at the DCR to start in 2027. This is a fixed-term position for an initial period of 3 years with possibility of renewal, in accordance with the University of Bern's employment regulations.

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.

Ihre Benefits

• Internationales Renommee
• Gute Forschungsinfrastrukturen und internationales Netzwerk
• Kollaboratives Umfeld und ambitioniertes Team
• Individueller KarrieresupportMehr erfahren