Medical Data Officer

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

Job summary

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.

Responsibilities

• 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

Job description

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