Medical Data Reviewer
Brabant Wallon, Belgium
We are looking for a Medical Data Reviewer for one of our clients based in Brabant Wallon.
The Medical Data Reviewer (MDR) is responsible for the review of patient data from study case report forms and to ensure completeness, consistency and robustness of the data towards its potential submission to regulatory authorities for the registration of the related product.
Role and main tasks:
- Reviews the data of each enrolled subject, in terms of eligibility, safety, efficacy and protocol compliance;
- Posts data queries to the concerned investigators through the EDC system when data deficiencies are detected or when data clarifications or confirmations are needed;
- Follows-up on timely resolution of data queries by the investigators;
- For each case that is fully reviewed and cleaned by him/herself, ensures that a final validation is performed by the study Lead;
- Reports weekly progress.
- Master degree or a PhD in science (ideally Biology).
- Ideally, a former experience as a data manager in a clinical trial;
- Data Management and Clinical Trials Business understanding;
- Excellent organizational and planning skills, analytical mind;
- Good knowledge and adherence to GCP principles and rules.