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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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$139,600.00 - $219,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
02/25/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
