Senior Associate, Senior Lab Data Specialist
Core
Senior Associate responsible for configuring lab data management tools, creating study-specific templates, maintaining lab IDs and reference ranges, and ensuring data standards compliance for clinical trial safety lab data.
Role type
Senior IC clinical data management specialist (lab data)
Builds
Clinical trial safety lab data sets and reports
Domain
Pharmaceutical clinical trials / Clinical data management
Required skills
Lab data management, EDC systems, CDISC standards, LOINC codes, SOP development, data reconciliation, relational databases, data visualization
Preferred skills
Drug development process knowledge, hospital/lab experience, data cleaning
Technologies
EDC systems, Oracle, Spotfire, J Review, Microsoft Office Suite
Responsibilities
Configure Lab Normal Management Tool per protocol, create protocol-specific templates for missing lab parameters, maintain Lab IDs and reference ranges in database, support Local and Central lab IDs, develop and maintain Lab Test Questions Library and unit conversions, finalize data management by assigning lab codes, map vendor test codes to internal codes, develop and update Lab related SOPs, support CDISC and LOINC implementation, serve as technical SME for lab data discrepancies and reporting, test new lab data listings and CTCAE grade reports, review lab reconciliation reports, drive process improvements and measure productivity metrics.
Seniority
Senior, hands-on IC