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Plan, establish, conduct, and document external national and global clinical studies (Phase I-IV) in the Dermatology Department, following Good Clinical Practice (GCP) guidelines.
Supervise and oversee academic and internal Investigator-Initiated Trials on a global scale.
Develop and implement new Investigator-Initiated Trials (IITs) and associated documents, in consultation with the Principal Investigator.
Manage projects, including planning, strategy, optimization, cost control, and reporting.
Coordinate submission procedures with authorities and ethics committees (Ethics Committee, Swissmedic).
Perform feasibility assessments and select sites for clinical trials.
Lead the planning and execution of trial recruitment and enrollment strategies.
Collaborate with external vendors (such as CROs) and service providers for trial-related activities.
Monitor and manage trial progress and milestones.
Manage trial budgets and resources.
Handle data management, monitoring, and analysis of trial data.
Prepare and take responsibility for studies, including monitoring visits.
Manage relationships with key opinion leaders and scientific advisory boards.
Contribute to the revision and expansion of Standard Operating Procedures (SOPs).
Profil
University degree (BSc or MSc in Biology, Biomedicine, Biochemistry or Pharmacy).
At least 5 years of professional experience as a Global Clinical Study Manager.
Current knowledge of the regulatory environment in Switzerland.
Very good knowledge of English language in spoken and written form, good knowledge of German and French.
Accurate, conscientious and goal-oriented working style and high sense of responsibility and quality awareness as well as high social competence.
Assertiveness and organizational talent, strong team and communication skills, resilience and the ability to act proactively.
Enjoyment in close collaboration with various professional groups and disciplines.
Service orientation and pronounced teamwork; open, appreciative communication.