Clinical Data Steward: Medical Safety & Data Integrity

Excelya; Bordeaux; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

Excelya is seeking a Medical Data Officer to join the Medical Affairs team in Bordeaux, France. The role focuses on ensuring the medical consistency of reported clinical data to keep the database accurate, reliable and analyzable.

You will collaborate closely with the Study Medical Reviewer, perform medical coding of adverse events and medical history, review investigator data, and support milestone extraction with efficient data processes.

Responsabilités

• Protocol Review especially topics linked to safety management, specific data that could need to be coded, inclusion, selection criteria, study design, pathology and mechanism of action of the IMP
• Database specification review and User acceptance test on eCRF, and Database validation tools used for medical review
• Participate in identification of Important Protocol Deviation detection method and their implementation (specifications, and UAT)
• Medical Coding of Adverse Events, medical and surgical history, other specific events and all treatments, including treatment indication.
• Medical Review might check the medical data entered by the investigator using available tools and processes and can create manual queries for clarification, confirmation, or correction if needed.
• Identify all non-serious adverse events according to strategy defined at the start of the study
• Handle the extraction process to support data available for important study milestones

Description du poste

Excelya is seeking a Medical Data Officer to join the Medical Affairs team in Bordeaux, France. The role focuses on ensuring the medical consistency of reported clinical data to keep the database accurate, reliable and analyzable.

You will collaborate closely with the Study Medical Reviewer, perform medical coding of adverse events and medical history, review investigator data, and support milestone extraction with efficient data processes.