System Design Analyst II - HYBRID
Core
Design and develop clinical trial systems ensuring compliance with data standards, protocols, and regulations to support clinical data strategy.
Role type
Senior System Design Analyst (Clinical Trials)
Builds
Clinical trial systems (EDC, IRT, ePRO) and integrations
Domain
Life Sciences / Clinical Trials
Deliverable
production ML models | product features | infrastructure
Required skills
Technical study build in EDC, Medidata RAVE, CDASH, SDTM, clinical trial processes, system design, project management, regulatory compliance (GCPs, ICH), mentoring
Preferred skills
Veeva EDC technical study build, Master's degree
Technologies
Medidata RAVE, Veeva EDC
Responsibilities
Develop common data standards and ensure system designs comply; Establish and maintain methodology for designing clinical trial systems; Ensure TA- and program-level consistency; Account for on-time design and delivery of new clinical systems and integrations; Interact with cross-functional teams to achieve program objectives; Ensure adherence to federal regulations and GCPs; Coach and mentor team members; Lead innovation and process improvement initiatives
Seniority
Senior, hands-on IC