Clinical Scientist 80-100%

vor 2 Wochen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**: For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Clinical Scientist 80-100%** for one year with option for extension. Roche provides clinical expertise and leadership for the medical value innovation pipeline of novel diagnostic solutions across all relevant disease areas at RDS to achieve their 10-year ambition. In close collaboration with many stakeholders, they also define the clinical product specifications, development strategies, and clinical study designs for product registration with adept medical writing, regulatory, and safety expertise. The department "Oncology & Genetics" provides medical expertise supporting the development of innovative solutions for the diagnosis and management of cancer and genetic diseases. **Tasks**: - The incumbent works proactively with CPS and global functions to analyze products of the CPS portfolio with regards to clinical evidence requirements according to the IVD-Regulations across all indication areas, and develops strategies to fill eventual evidence gaps - Work with Regulatory, Clinical Operations, Lifecycle teams, and R&D to generate Scientific Validity Assessments, Clinical Performance reports, and support the development of product requirements and specifications according to the IVD-Regulations (in vitro diagnostics) - Support Global Clinical Leaders (GCL) and Clinical Science Leaders (CSL) in the assessment and definition of Intended Uses (IU) and clinical testing purposes of CPS products - Assess clinical evidence and state of the art in medicine related to the CPS products and IUs to demonstrate clinical benefit and safety - Document proof of training according to SOP ‘Mitarbeiterentwicklung / Employee Development’ - Ensure continuous improvement of Medical and Scientific Affairs workflow to increase quality and efficiency - Optimizes processes in order to increase quality and efficiency standards **Must Haves**: - Min. Masters degree in biomedical, public health, epidemiological or medical field - Min. 3-5 years of experience clinical research, preferably in Oncology - Good IT-tools knowledge, especially with MS Office and/or gSuite - Good data analysis skills - Fluency in English written and spoken is a must - Willingness to learn, positive and open mindset, great team player - Innovation mindset and spirit - Excellent communication skills **Nice to Haves**: - Experience with IVD - Previous Roche experience

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