feedback

Medical Data Reviewer

Keyrus Biopharma

Brabant Wallon, Belgium

Job Description

We are looking for a Medical Data Reviewer for one of our clients based in Brabant Wallon.

Scope:

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.

Profile

Education:

  • Master degree or a PhD in science (ideally Biology).

Required skills:

  • 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.

For more details and to apply for this job click here

© EuroJobsites

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies