Clinical Trials Scientist

Would you like to be involved in the clinical trials of the Institute of Tropical Medicine (ITM)?

Then this is your chance ITM is a renowned internal institute that aims to improve global healthcare through scientific research. The Clinical Trials Unit (CTU) of ITM supports academic clinical trials which address health problems in Belgium and overseas in resource-limited settings.

You will join a dynamic group of clinical trial scientists, data managers and biostatisticians who, together with the clinical trial site teams, ensure the meticulous preparation, execution and reporting of various clinical trials and other clinical research projects. After an introductory period, you will have a varied range of tasks with a high degree of independence and a team of CTU-colleagues on which you can rely for feedback and support.

**What do we expect?**:

- 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, maintenance of trial master files, pharmacovigilance, and other GCP-related tasks.
- You will mainly coordinate and monitor phase II/III/IV 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 two years of experience in monitoring and coordination of GCP-compliant clinical trials, preferably in an academic setting.
- Ideally, you have experience in the preparation and submission of a clinical trial dossier to regulatory authorities and ethical committees.
- You have a good knowledge of ICH-GCP, EU Directives, and applicable Belgian laws. Knowledge of EU Regulation 536/2014 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. You are able to prioritize when confronted with a high workload and have excellent communication skills.
- You are available for short travels (up to 2 weeks), both in Europe and overseas (mainly developing countries).
- You have excellent knowledge of English and Dutch. Knowledge of French is an asset.

**What do we offer?**:
ITM is an open and international campus where staff, students and researchers work on the new international health challenges. Together we ensure a pleasant working atmosphere with attention to work-life balance and opportunities for training. We offer you:

- A fulltime employment as a scientific assistant, open-ended contract. Starting date as soon as possible.
- The ITM is located in the middle of the vibrant city of Antwerp and is easily accessible by public transport.
- A salary package depending on your profile and professional experience, and supplementary benefits, such as private pension scheme, meal vouchers, subscription and reimbursement of transport. Possibility to subscribe to a hospitalization insurance at beneficial terms.