The General 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.
- 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 (e.g., Medical Technology, Medical Laboratory Scientist, Clinical Laboratory Scientist, Nursing) or a 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

Location

US and Puerto Rico Residents Only.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights,



EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Salary

$142,400.00 - $224,100.00 – the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at

Additional Location Notes

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Requisition ID

R

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