Medical Data Reviewer

The main tasks of the MDR are to ensure that the study data is complete, robust and consistent from a medical perspective. In that respect, MDR are involved in a series of activities which are starting at study set-up, throughout the study conduct phase and until the database freeze. MDR are key experts who participate to several meetings such as Study Core Team meeting, specific meetings with CRDL/Epi, Data managers to ensure proper planning, execution and control of the activities. In addition, they can be in contact with countries/study managers to solve Data Queries.

Study set-up activities

• Review the following study documents and provide input as described below
• Provide input to electronic Case Report Form (e-CRF) specifications and annotated Study Book:
  • Compare the protocol and eCRF for the consistency
  • Ensure the capture of the critical data related to the statistical endpoints defined into the protocol
• Provide input into integrated Data Review Plan (iDRP):
• Automatic/manual checks/queries
• Individual data listings
• Patient profile specification, if applicable
• Contribute to the development of eCRF completion guidelines driven by DM
• Develop Medical cleaning guidelines in collaboration with CRDL– living document to be finalized before the DataBase Freeze (DBF).
• Participate to the Cleaning Strategy and Timings defined by the Study Data Manager (SDM) under Oversight Data Manager (ODM) and in collaboration with the Safety physician
• Contribute to Monitors/Investigators meetings to ensure understanding of eCRF completion guidelines
• Contribute to the organisation of the Adjudication Panel reviews, if applicable

Study cleaning phase

• Help experts from Data management team to answer study/disease specific queries.
• Review checks generated by automatic cleaning in iDRP.
• In addition to automatic cleaning, perform manual cleaning:
  • Review of subject data in the eCRF
  • Review of Patient Profile (PP) by batch of subjects, if applicable
  • Review of Medical listings including coding
  • Perform consistency batch to align review on all data
  • Review and perform quality control on elimination codes to ensure coherence across elimination codes attribution.
  • Support SDM activities for elimination codes reconciliation
  • Interact with Safety department for consistency between clinical and safety databases. MDR leads of meeting with Safety physician.

Set-up tools specific for the MDR role and used by Clinical R&D

• Tracking Tool (is used for the tracking of manual cleaning activities progress/timepoints and capturing of outstanding comments)
• Customize to the needs of the study/study design. Hence, it has to be developed for each study.
• Patient Profile (is an overview of clinical data reported, presented at subject level for manual cleaning and if needed, clinical assessment by external/internal panel of experts; contains relevant data captured, including endpoints impacting subsequent analyses)
  • Developed and reviewed by MDR.
• Other applications for data storage (e.g. e-Clinipix)
  • Customize the application together with DM expert.
  • Perform User acceptance test together with Study Data Manager.

Adjudication panel, if applicable

• Review Data Transfer Agreement developed by Oversight Data Manager
• Perform Clinical data cleaning and reconciliation in case of use of other applications than eCRF
• In case of queries by external panel, post/follow-up queries to sites and highlights readiness for transfer of answer back to panel

End of cleaning

• Finalize the review of elimination codes
• Participate to the pre-analysis meeting (PAM) preparation:
  • Data Management Report draft review by MDR for applicable codes
  • Support for Stat check review if applicable
  • Participation in Final PAM
• Provide manual and automatic cleaning listings to CDR for archiving
• Provide and approve cleaning guidelines

• Master degree or PhD in Sciences (ideally in Biomedical Sciences)
• Ideally, with an experience as a Data Manager in clinical trials.
  • Data Management and Clinical Trials Business understanding
• Excellent organizational and planning skills, analytical mind
• Fluent in English, French is an asset
• Good knowledge and adherence to GcP principles and rules
• Location: Brussels' surroundings