Clin Data Assoc II
Core
Lead advanced data review and cleaning activities to drive data integrity, timeliness, and inspection readiness across assigned clinical studies.
Role type
Senior Clinical Data Associate II (IC)
Builds
Analysis-ready datasets supporting safety and efficacy assessments for pharmaceutical and biotech clients
Domain
Clinical Data Management in Biopharmaceuticals
Required skills
Data discrepancy resolution, Query generation and tracking, Data listing review, SAE and third-party vendor reconciliation, CRF design, Regulatory guideline adherence (GCP/SOPs), Data validation report analysis
Preferred skills
RAVE/Veeva EDC proficiency, Medical/clinical trial terminology knowledge, Project protocol understanding, Interactive computer program usage
Technologies
RAVE, Veeva EDC
Responsibilities
Identify, resolve, and update data discrepancies; Generate, track, and resolve data clarifications and queries; Review data listings for accuracy and consistency; Produce project-specific status reports for CDM management and clients; Perform data management activities including SAE and Third Party Vendor reconciliations
Seniority
Senior, hands-on IC