Associate Director, Global Clinical Data Standards Vocabulary Specialist

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.

clinicaltrialjobs

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:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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:

We are proud to be a company that embraces the value of bringing together, talented, and 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.

The salary range for this role is

$142,400.00 - $224,100.00

This is 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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.