Associate Director, Global Clinical Data Standards Vocabulary Specialist
Core
Subject matter expert in CDISC Controlled Terminology applying terminology and reference data to clinical data collection and transformation specifications for global healthcare research.
Role type
Associate Director, Global Clinical Data Standards Vocabulary Specialist
Builds
Clinical data standards and specifications compliant with Health Authority regulations
Domain
Clinical Research / Pharmacovigilance / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDISC Controlled Terminology, Clinical Data Standards, Regulatory Requirements, Project Management, Mentoring Staff, Critical Thinking, Good Clinical Practice (GCP), Good Clinical Data Management Practice (GCDMP)
Preferred skills
SDTM application, MedDRA, WHODD, SNOMED, Genetics data, Immunogenicity, PK/PD, Questionnaire terminology, Lab values, Unit of measure conversions, Versioning of controlled terminology
Technologies
CDISC, SDTM, MedDRA, WHODD, SNOMED
Responsibilities
Lead or participate in internal clinical data standards forums, standards development teams, data governance reviews, and strategic process improvement projects; Mentor and guide junior staff; Maintain knowledge of emerging clinical study data standards and regulatory requirements
Seniority
Senior, hands-on IC with leadership responsibilities
