For our customer, a leader in medical diagnostics based in Rotkreuz, we are looking for a
- Overall accountability for generation of evidence ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements (e.g. FDA, IVDR)
- Ensures in-depth scientific expertise for cross-functional teams within and outside of MSA in the relevant indication area.
- Leads the global study team
- Develops study design for technical studies in coordination with internal and external experts and the development/project team with full responsibility for study protocol and study report
- Owns the study budget in cooperation with the Study Team
- Accountable for site selection in collaboration with Investigational Site Management
- Oversight on COSS support (e.g. contracting, sample acquisition and management, logistics etc.)
- Planning and oversight of tasks and work packages for external collaborators in collaboration with the appropriate function
- Accountable for data and study result validation, interpretation, drawing of recommendations and communication
- Accountable for archiving and audit/inspection readiness
- PhD / PharmD / MD in Life Science
- More than 3 years of experience in IVD or Medical Device Study Management in all stages of international clinical trials, study protocol design, report writing and leading matrix teams
- Experienced in biochemical, chemical or biophysical area with detailed knowledge in specific fields of diagnostics (e.g. coagulation, cardiology)
- Knowledge of applicable standards and regulations for clinical trials
- Professional use of the English language; both written and oral
- Prepared to travel (National & International)
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 44 225 41 12).
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