As a clinical study manager at MRIguidance, a UMC Utrecht spin-off company, you will be responsible for the regulatory strategy and the setup, management and follow up of clinical studies, which are of utmost importance forthe validation and certification of our product portfolio to facilitate market entry.

What you tell at birthdays about your job
“The company I work for prevents cancerin patients that need to undergo a bone scan. Nowadays, if someone needs a bone scan,radiologists use an x-ray based CT scan which exposes the patient to harmful radiation. The BoneMRI technique we developed is a radiation-free alternative that provides both bone and soft tissue information using only one machine and one exam. This reduces patients' burden, and saves time and money for hospitals. My job is to make sure our products are tested on patients in hospitals around the world and that our methods are safe and effective.”

What you actually will be doing
At MRIguidance, the performance of clinical validation studies is a crucial part towards CE and FDA certification and clinical introduction of our medical products. Yourtask will be the planning, management and administration of these clinicalresearch and validation studies. Utilizing existing templates and standard operating procedures in line with ISO 14155 and the MDR as a guide, you will help in setting up, implementing and monitoring these studies. You actively contribute in shaping the clinicalregulatory strategy within the company. You will facilitate communication and interaction with participating medical centers, medical ethical and legal organisations in Europe and the USA. An important part of your work is ensuring the study is properly documented. You keep track of the planning and timelines. You will be part of the clinical team and will be supported by the current clinical study managers and the QA officer of MRIguidance and report to the chief scientific officer.

Your responsibilities:

• Project management;
• Study administration;
• Design, write and review ethics/IRB approvals and regulatory submissions;
• Design, write and review study documents (clinical investigation plans and reports);
• Define the clinicalregulatory strategy;
• Maintain contact with doctors and researchers from participating medical centers, both in the Netherlands and abroad;
• Monitor and stimulate patient inclusion.

Our values
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. Within MRIguidance we are pragmatic, customer-oriented, and we believe in the strength of teamwork and a positive can-do mentality.

Minimum qualifications:

• Life Science or technical undergraduate/BSc;
• Knowledge of and experience with METC and IRB applications;
• Knowledge of ICH GCP and GDPR;
• Minimum 2 years of experience writing and reading regulatory documents and study protocols;
• Good administrative and organizational skills;
• Fluency in Dutch and English;
• Good knowledge of Microsoft Office tools;
• Able to work in teams and independently;
• Ambitious and eagerto learn;
• Ability to communicate and collaborate effectively with imaging researchers and clinical specialists.

Preferred qualifications:

• Knowledge of the MDR and ISO14155;
• Knowledge of the USA FDA process;
• Experience with multi-center and international clinical studies.

This is what we offer you:

• A market conform salary between €3.700 - €5.200/month;
• A unique opportunity to, at an early stage, become part of a med-tech scale-up with vast growth potential;
• Work that has a positive impact on people’s health and life;
• Work in a team of smart and ambitious people;
• Work with international partners;
• Work in a startup environment where you both get freedom and responsibility;
• Work at our beautiful office at Gildstraat 91a in Utrecht;

MRIguidance

During theirresearch MR physicist Peter Seevinck and medical image scientist Marijn van Stralen identified great unused potential for MRI-based medical imaging technologies. Together with entrepreneur Roel Raatgever, they founded UMC Utrecht spin-off company MRIguidance in 2016. The team of MRIguidance actively collaborates with hospitals in the Netherlands and abroad to acquire unique patient data sets and clinically validate and commercialise BoneMRI, the world's first imaging technique that visualises all human tissues from one imaging exam, without the use of harmfulradiation. MRIguidance’s BoneMRI software will improve diagnosis and is used for surgical planning and guidance. In July 2020, MRIguidance was selected as Europe's best-in-class innovation in healthcare by the European Institute of Innovation & Technology.