Job Description
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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 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 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 stakeholder management skills, influence 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 related discipline.
Required Skills:
- Clinical Data Management, Clinical Data Standards, Clinical Research, Critical Thinking, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Medical Laboratories, Mentoring Staff, Project Management, Regulatory Requirements, Stakeholder Engagement, Stakeholder Management
Preferred Skills:
