For our Coronary & Structural Heart (CSH) team at the Bakken Research Center in Maastricht in the Netherlands.
Careers that Change Lives
At our Bakken Research Center in Maastricht, about 220 clinical researchers, scientists and technical engineers cooperate closely with medical specialists in and outside of Europe to develop new and improve existing therapies in Coronary & Structural Heart (CSH) indications. Our broad range of clinical services includes international project management, statistical advice, IT support and medical writing, which makes us Medtronic’s authority on clinical research outside of the United States.
A Day in the Life
As a Principal Clinical Research Specialist, you are responsible for establishing, managing and meeting the milestones of one or multiple global clinical studies from study design to study closure. The clinical data that are collected will support product approvals as well as scientific presentations and publications, in close cooperation with leading physicians in the field.
Must Haves
• Masters or PhD degree in Life Sciences
• 5-7 years experience in leading large international registries with many sites in multiple countries
• Strong communication, critical thinking, problem-solving and networking skills
• Able and willing to strictly follow procedures/SOP's, regulations and guidelines
We are looking for a customer focused team player, comfortable to work in a complex matrix organization, who is a clinical expert, experienced in clinical study management, site management, study monitoring and local regulations. This means you are familiar with clinical research study design, GCP’s and regulatory compliance guidelines for clinical trials. Knowledge of ISO14155 is a plus, as well as experience with regulatory studies.
Besides the ability to manage multiple tasks, you dispose of good problem-solving skills and a high attention to detail and accuracy, while maintaining big picture overview and leadership. Quality focus is a must. You are used to take initiative and you demonstrate the ability to work effectively on cross‐functional teams. You may also act as a coach and mentor for junior team members. Furthermore, you have the ability to cultivate relationships with internal and external stakeholders and easily build rapport and trust using influence management skills.
You are a good communicator and fluent in English, both in writing and speaking.
Frequent (inter)national travel is part of the job (up to 20%).