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About the role
- Study Site Manager coordinating analytical performance studies in a clinical research environment at Roche. Ensuring compliance with regulatory requirements and high-quality standards.
Responsibilities
- Responsibility for the design, planning and coordination of analytical performance studies
- Management of study sites
- Preparation of submission documents for ethics committees and regulatory authorities
- Responsible for the setup, maintenance, and filing of study documents in the electronic Trial Master File (eTMF)
- Conducting monitoring visits at study sites
Requirements
- At least 3 years of experience in clinical research, for example as a CRA or study coordinator
- A degree in a natural science (Bachelor, Master or equivalent)
- Experience in a clinical laboratory environment
- Confident handling of regulatory frameworks such as IVDR and MPDG
- A high level of responsibility in documenting and reporting study results
- Fluent in English
Benefits
- Health services
- 401(k) matching
- Flexible working hours
- Paid vacation
- Opportunities for professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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