Associate Director, Global Clinical Data Standards Vocabulary Specialist

About the role

The Global Clinical Data Standards Vocabulary Specialist, Associate Director, will serve as the subject‑matter expert on CDISC Controlled Terminology and related reference data. Working within our Clinical Research and Pharmacovigilance team, you will ensure data collection and transformation specifications meet health‑authority regulations and company best practices.

Key responsibilities

• Apply CDISC Controlled Terminology to clinical trial data and ensure compliance with regulatory guidance.
• Interact with staff across multiple sites, providing mentorship and guidance to junior team members.
• Lead or participate in internal data standards forums, standards development teams, data‑governance reviews, and strategic process‑improvement projects.
• Represent the organization in industry forums and standards‑development initiatives.
• Maintain up‑to‑date knowledge of emerging clinical data standards, technologies, and regulatory requirements.

Required profile

• Minimum 8 years of pre‑clinical/clinical research experience, including at least 2 years focused on data standards.
• Bachelor’s degree in life sciences or a related discipline.
• Strong communication, stakeholder‑management, and project‑leadership abilities.

Required skills

• CDISC Controlled Terminology
• SDTM implementation
• MedDRA, WHODD, SNOMED
• Genetics, immunogenicity, PK/PD data handling
• Questionnaire data management
• Lab values unit‑conversion and terminology versioning
• Good Clinical Data Management Practice (GCDMP) and Good Clinical Practice (GCP)
• Clinical Data Management and Clinical Data Standards
• Project Management and Regulatory Requirements