We are going to make genetic testing available to everyone and to change the way genetic data is managed and analysed, through game-changing software solutions for personalized medicine.
A genetic test will be as easy and accessible as a simple blood test.
PlatoX® IVD Assistant launch in March 2023 - Pre-register now
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
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