Job Description
Global Clinical Data Standards Therapeutic Area Lead
At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in global health.
Responsibilities
- Define standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations.
- Ensure the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables.
- Lead standards data governance reviews.
- Contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards.
- Lead or participate in department initiatives, cross-functional working groups, and process improvement activities.
- Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and make frequent contacts external to the area and/or company.
- Maintain knowledge of new technologies, industry standards, regulatory requirements, and our company's guidelines and SOPs.
- Work independently or as a team member with equal effectiveness.
- Interact with staff across multiple company sites.
Qualifications
Required
- B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
- 8+ years’ work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.
- Advanced knowledge and leading-edge skills in clinical data standards.
- Study Data Tabulation Model (SDTM) expertise.
- InForm expertise.
- Analysis & Reporting experience.
- Program-level clinical and business requirements knowledge.
- Strong communication and presentation skills.
- Proficient in education, training, and facilitation.
- Must have an innovative spirit, outstanding interpersonal skills, leadership, and demonstrated proficiency in the management of multiple projects.
- Knowledge of clinical data management.
clinicaltrialjobs
EligibleforERP
#GDMS
**Required Skills: **
Adaptability, Adaptability, Business Processes, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Computer Science, Data Analysis, Data Collection Methods, Data Governance, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Establishing Contacts, Global Health, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Interpersonal Relationships, Mentoring Staff, Multi-Management, Process Improvements, Project Management, Project Management Tools, Regulatory Requirements {+ 2 more}
**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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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 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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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
**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:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
05/9/2026
***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. **