16 Oct
|
ICON San Antonio
|
Bengaluru
16 Oct
ICON San Antonio
Bengaluru
Medical Data Reviewer - India, Home-Based
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a cooperative environment where your work contributes to the development of treatments that benefit patients worldwide.
What Will You Do
• 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.
• Issues clinical data queries and ensure timely follow up following site responses as to 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 o
📌 Medical Data Reviewer (Bengaluru)
🏢 ICON San Antonio
📍 Bengaluru