Principal Clinical Data Standards Consultant
Core
Develop, implement, and maintain clinical data standards libraries (CDISC, CDASH, SDTM) for global healthcare intelligence and clinical research projects.
Role type
Principal Clinical Data Standards Consultant
Builds
ICON Data Collection standards libraries and sponsor-facing standards content
Domain
Clinical research / Healthcare intelligence / Regulatory compliance
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 requirements knowledge (FDA, EMA), complex problem solving, leadership, mentoring
Preferred skills
Advanced degrees in Life Sciences or Computer Science, Chinese language proficiency
Technologies
Medidata Rave, Veeva Vault EDC/CDMS, CDISC standards
Responsibilities
Provide expert-level functional knowledge in standards domains, guide standards implementation and compliance, collaborate cross-functionally to define data collection strategies, participate in standards governance, support development of training materials, stay updated with industry trends and regulatory changes, provide mentorship to junior team members, support Chinese language version of ICON Standards library
Seniority
Principal, hands-on IC with mentorship responsibilities
