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Platomics develops a global marketplace for personalized medicine to make the future of molecular diagnostics available today. We are a young vibrant team and apply the most advanced computing technologies to enable big data processing and analysis in healthcare. We are bioinformaticians, genetics researchers, software developers, and mathematicians. As a Clinical Evaluation Manager you:
-Manage the performance evaluation of our IVD products according to European Regulations
-Coordinate study partners (e.g. in multi-centric trials)
-Create and maintain Performance Evaluation Plans (PEP)
-Define relevant evaluation measures and design study protocols
-Collect and manage relevant literature
-Assessment of literature, document Scientific validity
-Support in planning and documentation of analytical performance evaluation
-Management of clinical performance evaluation and trials
-Coordination of Post-market performance follow-up PMPF (planning, design, analysis, documentation)
-Collaborate with external stakeholders involved in the performance evaluation, e.g. geneticists or physicians
-Communication to authorities, e.g. ethics committee, competent authorities
-Work with cross-functional teams, especially Regulatory Affairs and Quality Management
Required Qualifications
-Laboratory and/or medical and/or clinical background
-Degree qualification in medicine or related science subject
-Experience in scientific writing
-Experience with medical literature and publication databases
-Experience in clinical trials
-Strong organizational skills
-Excellent communication skills
-Very good English skills, especially writing in English
Preferred Qualifications
-Knowledge on regulatory standards and Performance Evaluation of medical or diagnostic devices
-Medical degree or advanced degree in medical sciences
-Knowledge of genetic testing
-Clinical genetic laboratory experience
-Translation of a device into clinical practice
-Experience with software as an IVD
-Knowledge of International Regulations, e.g. FDA
-German language skills
We offer:
-Interdisciplinary and dedicated teams
-Exciting challenges in a fast moving domain
-A flexible work schedule
-Convenient office location close to U1, U2, and U4 metro station Karlsplatz in Vienna
For this position you will earn a salary of € 65.000 per year, willingness for over-payment is given for candidates with proper experience and/or qualifications.
If you are interested in strengthening our development team please e-mail your CV and a letter of motivation to our HR department at careers@platomics.com or call +43 660 222 03 95
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Bewerbung
