at Merck in Dover, Delaware, United States
Job Description
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
+ C DISC 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.
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In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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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, generally Tuesday, Wednesday and either Monday or 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$130,960.00 – $206,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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