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As a clinical study manager at MRIguidance, a UMC Utrecht spin-off company, you will be responsible for the setup, administration, management, follow up and monitoring of clinical studies, which are of utmost importance for the validation and certification of our product portfolio to facilitate market entry.
What you tell at birthdays about your job
“The company I work prevents cancer in patients that need to undergo a bone scan. We create software solutions that help doctors to better diagnose and cure their patients. I am responsible for the clinical studies that proof that our software is safe and actually benefits the patients”.
What you actually will be doing
At MRIguidance, the performance of clinical validation studies is a crucial part towards CE-marking and clinical introduction of our product. Your task will be the planning, setup, management and follow up of these clinical research and validation studies. You will be involved in the design, writing and statistical considerations of the research protocols. Utilizing existing templates and standard operating procedures in line with ISO 14155 as a guide, you will be responsible for implementing, administering and monitoring these studies. You will facilitate communication and interaction with participating medical centers, medical ethical and legal organisations and the notified body and are responsible for the organisation of the documentation. You keep track of the planning and timelines. As MRIguidance is a small but growing company, we stimulate personal growth and development such that your skills and capabilities grow with the needs of the company. You will work in close cooperation with the Quality Assurance officer of MRIguidance and report to the CSO.
Your responsibilities:
Minimum qualifications:
Preferred qualifications:
This is what we offer you:
During their research MR physicist Peter Seevinck and medical image scientist Marijn van Stralen identified great unused potential for MRI-based medical imaging technologies. Together with Roel Raatgever, former director of Europe’s no.6 academic business incubator UtrechtInc, they have founded UMC Utrecht spin-off company MRIguidance. The team of MRIguidance actively collaborates with hospitals in the Netherlands and abroad to acquire unique patient data sets and clinically validate the results of the deep learning developments. MRIguidance is a fast growing company of which you will become colleague no. 10. The enthusiastic team works in a inspiring work environment in Utrecht together with other young companies. We work hard, but there’s always room to play hard.
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