Job Description The Integral Clinical Data Standards Vocabulary Specialist, Associate Director is a subject matter expert in CDISC Controlled Terminology and applies terminology and associated reference data to data collection and transformation specifications, complying with Health Authority regulations, guidance, and company best practices.

The Vocabulary Specialist Is Able To Work independently, collaboratively as a member of a team, or successfully as a leader, with equal effectiveness.

Interact with staff across multiple of our company's sites.

Mentor, guide, and provide direction to junior staff, as assigned.

The Vocabulary Specialist May Lead Or Participate In Internal clinical data standards forums Standards development teams and data governance reviews Strategic and process improvement/design projects Industry forums and standards development teams The Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in industry,



and our company's guidelines and SOPs.

Required Experience 8 years’ work experience in pre-clinical/clinical research including a minimum of 2 years’ experience in data standards, with a strong emphasis on managing and applying CDISC Controlled Terminology.

Preferred Experience CDISC Standards and the application of SDTM and its associated controlled terminology.

Knowledge of clinical research-controlled terminology (e.g., MedDRA, WHODD, SNOMED).

Understanding of a variety of external data types (e.g., genetics, immunogenicity, PK/PD).

Understanding of collection and terminology associated with questionnaires.

Understanding of lab values and the importance and maintenance of unit of measure conversions.

Knowledge of versioning and maintenance of controlled terminology.

Excellent communication/presentation skills.

📌 Associate Director, Global Clinical Data Standards Vocabulary Specialist (Argentina)
🏢 Msd
📍 Argentina