Principal Clinical Data Standards Consultant
Core
Develop, implement, and maintain clinical data standards libraries (CDISC, CDASH, SDTM) to ensure compliance with regulatory requirements for clinical trials.
Role type
Principal Clinical Data Standards Consultant
Builds
ICON Data Collection standards libraries and sponsor-facing standards content
Domain
Healthcare / Clinical Research / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDISC standards expertise (CDASH, SDTM, Controlled Terminology), EDC build/design tools (Medidata Rave, Veeva Vault EDC/CDMS), regulatory knowledge (FDA, EMA), complex problem solving, leadership, mentoring
Preferred skills
Advanced degrees in Life Sciences or Computer Science
Technologies
Medidata Rave, Veeva Vault EDC/CDMS
Responsibilities
Develop and maintain ICON Data Collection standards libraries; Act as a subject matter expert to guide standards implementation; Collaborate cross-functionally to define data collection strategies; Participate in standards governance activities; Support the development of training materials and reference documentation; Provide mentorship to junior team members
Seniority
Principal, hands-on IC with mentorship responsibilities
