Clinical Trials Scientist/Clinical Project Manager

Would you like to contribute to clinical research that improves health worldwide?

More than 500 staff members at the Institute of Tropical Medicine (ITM) contribute every day to improving the health of millions of people worldwide. Our researchers conduct more than 100 scientific projects in the fields of tropical medicine and international health. Our teaching staff welcomes more than 500 professionals from around the world each academic year, while our clinic and reference laboratories provide high-quality services to thousands of patients and partners.

There is only one way we can accomplish these diverse tasks: through a shared passion for our mission.

The Clinical Trials Unit (CTU) supports academic clinical trials that address important health challenges in Belgium and in resource-limited settings worldwide.

As a Clinical Trials Scientist (Clinical Project Manager), you will join a dynamic team of clinical trial scientists, data managers and biostatisticians. Together with clinical trial site teams, you will contribute to the preparation, execution and reporting of clinical trials and other clinical research projects. Following an onboarding period, you will take on a varied role with a high degree of autonomy, while being supported by experienced colleagues within the CTU.

Would you like to make a meaningful impact through clinical research? Apply now for the position of Clinical Trials Scientist (Clinical Project Manager).

Your responsibilities:

·       You are responsible for full clinical trials management, including, but not limited to: project planning and coordination, assisting in writing of clinical trial protocols, informed consent forms and other essential documents, ethical and regulatory submissions, study monitoring (both in Belgium as overseas (mostly African countries)), preparation of investigator files, maintenance of trial master files, pharmacovigilance, and other GCP-related tasks.

·       You will mainly coordinate and monitor phase II/III clinical trials as well as diagnostic studies or other studies in humans, carried out in Belgium and overseas in resource-limited settings.

·       You will participate in courses of the CTU related to Good Clinical Practices (GCP) and assist in training of young researchers involved in clinical research, both in Belgium and overseas in resource-limited settings.

·       You report to the Head of the Clinical Trials Unit.

Your profile:

·       You hold a Master in Medical sciences, Biomedical sciences, Pharmacy or in other relevant life sciences.

·       You have at least five years of hands-on experience in monitoring and coordinating GCP-compliant clinical trials, experience with academic studies in resource limited settings is a strong asset. 

·       You have demonstrated leadership skills, specifically in clinical project management, and are used to set-up, coordinate and follow-up clinical trial operational activities as a sponsor representative and in collaboration with principal investigators and site teams.

·       You have experience in the preparation and submission of a clinical trial dossier to regulatory authorities and ethical committees in Belgium. Experience with the preparation of trials which include a medical device is an asset.

·       You have a good knowledge of ICH-GCP, EU Regulation 536/2014, and applicable Belgian laws. Knowledge of EU medical device regulation 2017/745 is an asset.

·       You have good presentation skills and you are willing to participate in educational activities.

·       You are a team player and problem solver with a proactive mindset. You can prioritize when confronted with a high workload and have excellent communication skills.

·       You are available for short travels (up to 2 weeks), mainly overseas and predominantly to resource-limited settings (potentially including countries or regions with political instability or unrest).

·       You can manage multiple priorities and work effectively in a dynamic environment.

·       You have good knowledge of Office applications; experience with electronic data management systems is a plus.

·       You have excellent knowledge of English and Dutch and a good knowledge of French.

What do we offer

The Institute of Tropical Medicine is committed to fostering a diverse, equitable, and inclusive work environment. Through your role, you will contribute to ITM’s socially relevant mission.

We highly value human dignity and diversity, academic creativity, and a critical mindset, with a strong focus on solidarity and collaboration. The wellbeing of our staff, students, patients, and clients is central to everything we do. We offer you:

·       A full-time or part-time (minimal 80%) employment as a scientific assistant, in a two-year contract (with the possibility of extension depending on the needs of the CTU). Starting date as soon as possible.

·       A collegial working environment with attention to work-life balance and individual growth and development.

·       A workplace in the middle of the vibrant city of Antwerp, easily accessible by public transport. A salary package depending on your profile and professional experience, and supplementary benefits, such as private pension scheme, meal voucher subscription and reimbursement of transport.