Principal Clinical Data Standards Consultant
Core
Develop, implement, and maintain clinical data standards libraries (CDISC, CDASH, Controlled Terminology) for sponsor-facing projects and internal use, ensuring compliance with regulatory requirements.
Role type
Principal Clinical Data Standards Consultant
Builds
ICON Data Collection standards libraries and compliant clinical data management processes
Domain
Clinical Research / Healthcare Intelligence
Required skills
CDISC standards expertise (CDASH, SDTM, Controlled Terminology), regulatory knowledge (FDA, EMA), EDC tool proficiency (Medidata Rave, Veeva Vault EDC/CDMS), complex problem solving, leadership, mentoring
Preferred skills
Advanced degree 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 ensure compliance; collaborate cross-functionally to define data collection strategies; participate in standards governance; support development of training materials; stay updated on industry trends and regulatory changes; mentor junior team members; support Chinese language version of standards library.
Seniority
Principal, hands-on IC with mentorship responsibilities