Clinical Data Steward - Medical Insights & Integrity

Excelya; Boulogne-Billancourt; On-site; EUR 42,000 - 64,000; Full time

Job summary

Excelya is seeking a Medical Data Officer to join our Medical Affairs team in France. You will contribute to managing and reviewing medical data for accuracy, reliability, and analyzability in clinical studies.

In this role, you will perform study setup tasks such as protocol review, eCRF validation, and UAT, and study conduct tasks including medical coding of adverse events and data extraction to support key milestones. Collaboration with the Study Medical Reviewer is essential.

Qualifications

• Experience: J

Responsibilities

• Study Setup Tasks: 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)
• Study Conduct Tasks: 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

Job description

Excelya is seeking a Medical Data Officer to join our Medical Affairs team in France. You will contribute to managing and reviewing medical data for accuracy, reliability, and analyzability in clinical studies.

In this role, you will perform study setup tasks such as protocol review, eCRF validation, and UAT, and study conduct tasks including medical coding of adverse events and data extraction to support key milestones. Collaboration with the Study Medical Reviewer is essential.