System Design Analyst II-Clinical Systems- HYBRID
Core
Design and deliver clinical trial systems (EDC, IRT, ePRO) ensuring compliance with data standards, protocols, and regulations.
Role type
Senior IC clinical systems design analyst
Builds
Clinical trial systems and integrations for pharmaceutical research
Domain
Life sciences / Clinical trials
Deliverable
production ML models | product features
Required skills
EDC technical study build, Medidata RAVE, CDASH, SDTM, clinical trial processes, system design, project management, regulatory compliance (GCP, ICH), mentoring
Preferred skills
Veeva EDC technical study build, Master's degree
Technologies
Medidata RAVE, Veeva EDC
Responsibilities
Develop common data standards for clinical systems; Establish and maintain methodology for system design; Ensure TA- and program-level consistency; Account for on-time design and delivery of 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