Overview
In this role you will support phase I–III clinical trials by ensuring accurate, timely data management under ICH/GCP guidelines. You will work within the Data Management team to maintain data quality, drive reconciliation and testing activities, and keep documentation up to date. You will collaborate with cross-functional teams to ensure clean databases and compliant data practices. This position offers the chance to impact trial integrity and patient safety in a global research setting.
Responsibilities
- Ongoing data review and reconciliation of third-party data streams and SAEs with the safety database
- User Acceptance Testing (UAT) of clinical databases
- Quality Control (QC) of clinical databases
- Ongoing updates of Data Management-related documentation
- Ensure data processes align with ICH/GCP and study timelines
Key requirements
- Bachelor’s degree or related allied health certification; 3+ years of data management experience
- Experience with Electronic Data Capture (EDC) systems; Inform EDC preferred
- Oncology and/or inflammatory therapeutic area experience
- Electronic Data Capture (EDC) systems (Inform EDC)
- Data reconciliation and QC processes
- Documentation and data management workflow maintenance
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