Associate Director, Global Clinical Data Standards Vocabulary Specialist

About the role

Our Clinical Research and Pharmacovigilance team is seeking an Associate Director who will serve as the Global Clinical Data Standards Vocabulary Specialist. In this role you will act as the subject‑matter expert for CDISC Controlled Terminology and ensure that data collection and transformation specifications comply with health‑authority regulations and company best practices.

Key responsibilities

• Develop, maintain and apply CDISC Controlled Terminology across clinical studies.
• Lead or participate in internal data standards forums, standards development teams and data‑governance reviews.
• Collaborate with cross‑functional teams across multiple sites, providing mentorship and guidance to junior staff.
• Drive strategic process‑improvement projects and represent the organization in industry standards forums.
• 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.
• Strong knowledge of CDISC standards, SDTM and associated controlled terminology.
• Familiarity with clinical research terminologies such as MedDRA, WHODD and SNOMED.
• Understanding of genetics, immunogenicity, PK/PD data, questionnaire collections and laboratory unit conversions.
• Excellent communication, stakeholder‑management and project‑leadership abilities.

Required skills

• CDISC Controlled Terminology
• SDTM
• MedDRA
• WHODD
• SNOMED