QC Specialist
Core
Perform quality control activities including documentation review and testing for Biometrics client deliverables within clinical trial data management.
Role type
Quality Control Specialist (Clinical Data Management)
Builds
Quality assurance for clinical trial data deliverables
Domain
Life Sciences / Clinical Trials / Biometrics
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Quality control procedures, documentation review, testing, clinical trial methodology, ICH/GCP guidelines, 21 CFR Part 11, CDASH, SDTM, Medidata Rave EDC, SQL Server, Oracle, database structures, programming languages
Preferred skills
Analytic discipline background, training and knowledge transfer, stakeholder liaison, project timeline management
Technologies
Medidata Rave EDC, SQL Server, Oracle, Microsoft Office
Responsibilities
Perform quality control activities on eCRFs, Data Validation Specifications, Custom functions, Data Extracts, Data Integrations, Data Mapping, and Custom Data Management Reports; Participate in the design and development of quality control procedures; Manage documentation created during the QC process; Liaise with study teams and other staff; Develop and lead execution of training and knowledge transfer opportunities for the quality control team; Collaborate with the project team to ensure deliverables are completed on time with high quality
Seniority
Mid-level, hands-on IC
