DescriptionJob Summary:
The Data Specialist ensures the accuracy, integrity, and timeliness of clinical trial data from study startup through closeout. This role supports data collection, review, and cleaning in compliance with GCP, ICH guidelines, FDA regulations, sponsor requirements, IRB approvals, and internal SOPs. The Data Specialist works closely with Principal Investigators, CRCs, Regulatory staff, monitors, sponsors, and CROs to support high-quality research execution.
Key Responsibilities:
Data Management & Quality Control
- Perform accurate EDC data entry and ongoing data review across multiple studies, ensuring consistency with source documentation.
- Generate, track, and resolve data queries with CRCs and investigators within sponsor timelines.
- Support remote monitoring, SDV readiness, database lock activities, and interim/final analyses.
Electronic Systems & Tools
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