Become our new
Clinical Study Manager

Are you interested in setting up, implementing and monitoring studies in hospitals around the world to make sure our methods are safe and effective?

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 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 for prevents cancer in 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.”    

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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. Your task will be the planning, management and administration of these clinical research 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. With your proactive attitude you will familiarise yourself with applicable guidelines, regulations and requirements for these studies. 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 Head of clinical affairs.

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

MRI guidance is a small but growing company, where personal growth and development is stimulated such that your skills and capabilities grow with the needs of the company. We believe in the strength of a collaborative and trustworthy team motivated to disrupt and shape the future of medical imaging. We are a community of reliable and competent professionals with the drive to always improve ourselves, our work and our product. Everyone is encouraged to bring out the best in others

Qualifications

Minimum qualifications:

  • Life Science or medical/technical MSc degree;
  • Experience with clinical studies activities;
  • Knowledge of and experience with ethical committee applications;
  • Good administrative and organizational skills;
  • Fluency in Dutch and English;
  • Good knowledge of Microsoft Office tools;
  • Able to work in (international) teams and independently;
  • Ambitious, proactive and eager to learn;
  • Passionate about making a difference;
  • Ability to communicate and collaborate effectively with imaging researchers and clinical specialists

Preferred qualifications:

    • Knowledge of the ICH GCP, MDR and ISO14155;
    • Knowledge of the USA FDA process;
    • Experience with international (multi-center) clinical studies and industry-initiated studies.
Our offer
  • A market conform salary between €3.000 – €4.000/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;

We believe diversity is beneficial for the creativity and a good atmosphere of our company. However, Dutch regulation makes it very complicated for small companies to process a work visa for people from outside the EU . Therefore, all people are welcome to apply, as long as we do not have to arrange a work visa.

Interested or curious about the position?

To apply, please send a motivation letter and your CV to Carrie Wismans by email: apply@mriguidance.com

Application closes on March 1, 2022.