The Institute of Tropical Medicine (ITM) is internationally recognised as a centre of excellence for education, research and service provision in the field of tropical medicine. The Clinical Trials Unit (CTU) collaborates with clinical researchers at ITM and at partner institutions. The CTU is setting up and conducting clinical trials as well as other research studies in humans which address health problems in Belgium and in resource-limited settings in the South. To support the increasing number of projects coordinated by the CTU, we are looking forward to extend our team with a clinical research data manager.
- You will be responsible for the data management of clinical trials and other research studies conducted in collaboration with the Clinical Trials Unit of ITM. As such, you will design, develop and manage GCP-compliant study databases and interact with researchers, data reviewers, trial coordinators and statisticians.
- Depending on the projects, you can be involved in the review and cleaning of the study database as well as in the preparation and completion of database lock.
- You will ensure that CTU data management procedures are in line with appropriate standards and guidelines, such as ICH-GCP and FDA 21CFRPart11.
- You will represent ITM in working groups, networks, conferences and events on clinical trials and clinical data management.
- You will explore new methodological approaches to clinical data management and apply them when appropriate.
- You will prepare study-specific documents related to the data management lifecycle, including e.g. case report forms, (e)CRF completion guidelines, standard operating procedures, system validation forms, data management plans, database lock and data archiving notes,… etc.
- You will assist in data management trainings of researchers and other stakeholders involved in clinical research in Belgium and in resource-limited settings.
- You will report on study progress, in line with deadlines and milestones, to the head of the Clinical Trials Unit.
- You hold a bachelor’s or master’s degree in IT/Biomedical IT or you have relevant proven experience in data management on your track record.
- Preferably, you have at least two years of experience within clinical trial data management and specifically in designing and managing clinical study databases.
- Experience with developing study databases in REDCap or in other GCP-compliant software tools for electronic data capture is a very strong asset.
- Knowledge of MySQL is an asset.
- You are eager to learn and you can work independently.
- You have an eye for detail and you are well organised.
- Previous experience in an academic setting and working with partners in resource-limited countries is a plus.
- You have good presentation and communication skills and you are willing to participate in educational and training activities.
- You are a team player and problem solver. You are stress resistant and able to prioritise when confronted with a high workload.
- You are open to short travels (1 to 2 weeks), both in Europe and overseas (mainly resource-limited settings), for providing data management training to study collaborators.
- You have excellent knowledge of Office applications.
- You have excellent knowledge of English and French. Knowledge of Dutch is an asset.
ITM is an open and international campus where staff, students and researchers work on the new international health challenges. We strive for excellence, integrity, specificity and efficiency. Your assignment contributes to our mission. We value human dignity and diversity, academic creativity and a critical spirit, solidarity and cooperation, and the well-being of employees, students, patients and clients. Together we ensure a pleasant working atmosphere with attention to work-life balance and opportunities for training. We offer you:
- A fulltime employment for one year, extendable. Starting date as soon as possible.
- A salary according to the scales of the Flemish universities and to your work experience, with supplementary extra-legal benefits: a public transport subscription and/or bicycle fee, private pension scheme and meal vouchers subscription.
For more information contact HR (email@example.com). Please send your CV with your letter of motivation to firstname.lastname@example.org before 4 June 2021.
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