Clinical Data Manager - Data Integrity & Investigation
Core
Ensuring data integrity and investigating discordances in subject- and sample-level data for method-comparison and specimen-collection studies to guarantee datasets reflect the true story for FDA submissions.
Role type
Senior Clinical Data Manager (Data Integrity & Investigation)
Builds
Validated datasets for regulatory submission (FDA) and internal scientific analysis
Domain
Clinical Research / In Vitro Diagnostics (IVD) / Regulatory Compliance
Required skills
Data investigation and root cause analysis, Source Data Verification (SDV), Query management, Database lock, Reconciliation of lab results/inventory/demographics, ALCOA+ principles, 21 CFR Part 11 compliance, EDC system configuration, Biostatistical literacy for signal vs artifact detection
Preferred skills
FDA submission experience (510(k), CLIA waiver), GCP/ICH familiarity
Technologies
Castor, Cloudbyz, REDCap, Medidata
Responsibilities
Trace discordant results and outliers to their source, verify critical fields against source documents, reconcile data across systems, explain data meaning to science and regulatory teams, defend dataset values under audit, build and refine eCRFs and edit checks
Seniority
Mid-Senior, hands-on IC