Clinical Data Specialist
Core
Ensure accuracy and quality of clinical data through validation, quality control, and reconciliation processes for clinical trials.
Role type
Clinical Data Specialist
Builds
Clinical trial data integrity and regulatory compliance
Domain
Pharmaceutical / Clinical Research
Required skills
Medidata RAVE (EDC), data validation, query management, UAT, SAS, data reconciliation, CDISC, HL7, regulatory guidelines (FDA/EMA)
Preferred skills
SQL, R, Python, data cleaning, transformation
Technologies
Medidata RAVE, SAS, SQL, R, Python
Responsibilities
Verify data consistency and identify discrepancies; raise and manage queries to resolve data issues; perform UAT for CRF changes and system updates; create and track form entry and query metrics; review data listings and reports for accuracy; perform data reconciliation to ensure data integrity; provide input to Data Review Guidelines and Quality Management plans; facilitate training for new team members.
Seniority
Mid-level, hands-on IC