Specialist, EDC User Acceptance Testing, Quality Control & Development
Core
Develop and validate Electronic Data Capture (EDC) systems for clinical studies, ensuring data quality and compliance with regulatory standards.
Role type
Specialist, EDC Development and User Acceptance Testing (UAT)
Builds
Early to late phase clinical study databases in Medidata Rave
Domain
Biotechnology / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EDC development, Medidata Rave, UAT methodologies, test script development, defect management, 21 CFR Part 11, ICH-GCP, CDISC standards, Data Management processes
Preferred skills
Medidata Builder Certification, C# programming, TrialGrid knowledge
Technologies
Medidata Rave, Rave Architect, Rave Amendment Manager, IxRS
Responsibilities
Build study setups including user administration and alert configurations; execute end-to-end UAT from planning to sign-off; track and resolve UAT issues; conduct quality control on eCRF design and integrations; document QC findings and improve checklists; manage post-production changes and third-party integrations
Seniority
Specialist, hands-on IC
