Medical Data Officer

Excelya; Boulogne-Billancourt; Vor Ort; EUR 42.000 - 64.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• Experience: J

Aufgaben

• 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

Jobbeschreibung

About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. The Medical Data Officer works in close collaboration with the Study Medical Reviewer and participates in managing/reviewing the medical consistency of reported clinical data to ensure that medical data in database are accurate, reliable and analyzable.

Main 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

Requirements About You At Excelya, taking audacious steps is encouraged , so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: J