Systems Design Analyst II
Core
Designing and developing clinical trial systems (EDC, IRT, ePRO) to ensure data standards, functionality, and regulatory compliance for clinical trials.
Role type
Senior Systems Design Analyst
Builds
Clinical trial systems, integrations, and required changes to clinical systems
Domain
Clinical trials / Life sciences / Health tech
Deliverable
production ML models | product features | infrastructure
Required skills
Clinical trial process knowledge, CDASH and SDTM standards, system design, project management, regulatory compliance (GCPs, ICH), mentoring
Preferred skills
Master's degree, 7+ years in similar technical or clinical development roles
Technologies
EDC, IRT, ePRO, project management tools
Responsibilities
Develop common data standards and ensure system designs comply with standards and protocols; Establish and maintain methodology for designing clinical trial systems; Ensure systems optimize functionality, user experience, and data flow; Achieve TA- and program-level consistency; Deliver new clinical systems and integrations on time; Track study progress and plan work; Identify issues affecting timelines or quality; Influence cross-functional teams to achieve objectives; Synchronize work products with dependencies; Ensure adherence to federal regulations, GCPs, ICH Guidelines, and SOPs; Coach and mentor team members; Lead innovation and process improvement initiatives
