Global Clinical Data Standards, Vocabulary Specialist
MSDAbout the role
Job Description
The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled Terminology and applying terminology and associated reference data to data collection and transformation specifications in compliance with Health Authority regulations and 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 our company's sites
Promote teamwork across GCDS by actively communicating and proactively sharing information
Support senior/leadership roles, in areas of observed competence, to enhance standards and associated processes for growth opportunities
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
5+ years’ work experience in pre-clinical/clinical research to include minimum 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 (i.e., MedDRA, WHODD, SNOMED).
Understanding of a variety of external data types (i.e., 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.
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
Education
B.A. or B.S. degree, preferably in life sciences (i.e., Medical Technology, Medical Laboratory Scientist, Clinical Laboratory Scientist, Nursing) or equivalent experience in relevant discipline.
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