Medical Data Reviewer

Serve as a Clinical Data reviewer and identify any errors in data by performing data review that

require further clarification with the study site.

Perform ongoing review of clinical / medical aspects of assigned patient data and documents

(escalates to Regeneron Clinical Scientist and / or medical monitor, as appropriate)

• Examples include but not limited to : Patient eligibility, diagnosis, medical history and

prior treatments, study drug administration, AE / SAE / AESI, con meds, safety labs,

efficacy assessments, EOT, EOS, survival, coding, etc.

whether the queries are appropriately addressed, and updates in EDC done, if

applicable, by either closing out the queries or re-querying, as applicable

Communicates any data training needs for CRAs, sites, etc.

Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol

compliance and targeted review of patient data)

Provide clinical data Project Management and viewed as an expert in data clinical / medical

review and cleaning.

Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation

Compliance.

May assist in review and contribute to data capture requirements guidance in line with protocol

and reporting requirements.

Monitor site data entry performance and provide leadership to identify root causes of data

issues and implement remedial actions.

Ensure timely follow-up and resolution of data related compliance issues.

Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables.

May contribute to EDC completion training.

May participate in clinical data review meetings such as :

Preferred candidate profile

crosscheck experience. 8+ years is preferrable.

Skills Required

Pharmaceutical, Monitoring