Associate Director, Global Clinical Data Standards Vocabulary Specialist

About the role

The Global Clinical Data Standards Vocabulary Specialist, Associate Director, leads the application of CDISC Controlled Terminology across clinical research and pharmacovigilance activities. This senior position works both independently and as part of cross‑functional teams to ensure data collection and transformation meet health authority regulations and company best practices.

Key responsibilities

• Develop, maintain, and apply CDISC Controlled Terminology and related reference data.
• Lead or participate in internal data standards forums, standards development teams, and data governance reviews.
• Drive strategic process‑improvement projects and contribute to industry standards initiatives.
• Mentor junior staff and provide guidance on terminology usage.
• Stay current with emerging clinical data standards, regulatory requirements, and internal SOPs.

Required profile

• Minimum 8 years of experience in pre‑clinical/clinical research, including at least 2 years focused on data standards.
• Bachelor’s degree in life sciences or a related discipline.
• Proven ability to work collaboratively across multiple sites and lead cross‑functional initiatives.

Required skills

• CDISC Controlled Terminology
• SDTM implementation
• MedDRA, WHODD, SNOMED knowledge
• Genetics, immunogenicity, PK/PD data handling
• Questionnaire terminology management
• Lab unit conversion and measurement standards
• Versioning and maintenance of controlled terminology
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)