CLINICAL EVALUATION MANAGER IVD
(FULL-TIME)

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. Our backgrounds are in bioinformatics, genetics, software development, and quality management.

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

  • Knowledge on IVDR and relevant standards and guidelines regarding Performance Evaluation of IVD devices

  • Laboratory and/or medical and/or clinical background

  • Experience in Scientific Writing

  • Experience with Medical literature and publication databases

  • Experience in clinical trials

  • Strong organizational skills

  • Very good English skills, especially writing in English

Preferred Qualifications

  • Degree in medical science or comparable domains

  • Profound knowledge in genetic testing

  • Laboratory Know-how

  • Experience with software as an IVD

  • Experience with genetic testing

  • Excellent communication skills

  • Knowledge on International Regulations, e.g. FDA

  • German 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 minimum salary of € 3.565 per month (IT-KV), 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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