Job Description
Senior Programmer / Lead CDS Developer (AI & Automation)
Brief Description of Position
Leads and executes clinical database development and programming activities across multiple clinical programs. Ensures delivery of high-quality, compliant, and timely clinical database solutions aligned with established standards and study requirements.
Acts as a technical SME supporting study teams, cross-functional partners, and vendors. Contributes to database design, development, validation, and integration activities, while driving continuous improvement, operational efficiency, and consistency across CDS processes.
Key Responsibilities
Clinical Database Delivery & Execution (40%)
- Oversees and coordinates clinical database activities across multiple clinical programs
- Interfaces with CDS leadership to ensure consistency of technical strategies and execution
- Plans and manages timelines to ensure on-time delivery of database-related activities
- Collaborates with study teams, stakeholders, and vendors to translate requirements into deliverables
Database Development & Programming (20%)
- Designs, develops, and maintains clinical databases and data transfer files according to specifications
- Programs and validates edit checks, derivations, and scripts supporting data ingestion and integration
- Leads and participates in review of eCRFs, edit checks, and database build activities
- Ensures adherence to standards, SOPs, and process guidelines
Training, Mentorship & SME Support (20%)
- Trains new hires and supports ongoing capability development across the team
- Acts as a subject matter expert for troubleshooting, issue resolution, and best practices
- Promotes a high-quality, customer-focused, and collaborative working environment
Innovation, Process Improvement & Digital Enablement (15%)
- Leads and participates in task forces, system evaluations, and CDS technical initiatives
- Contributes innovative solutions to enhance processes and increase productivity
- Supports the evaluation and adoption of improved ways of working, including appropriate use of automation and data-driven approaches
- Demonstrates awareness of emerging digital capabilities (e.g., automation, advanced analytics, AI-enabled tools) and explores their applicability to improve efficiency and consistency
Planning & Coordination (5%)
- Supports project planning, resource forecasting, and workload distribution across therapy areas
- Aligns with CDS leadership to ensure consistency of approach across programs
Qualifications, Skills & Experience
Education
- Bachelor’s degree in computer science, mathematics, science, or a related field (or equivalent experience)
Experience
- 4–7 years of clinical database development and/or data programming experience
- Strong experience with clinical data management systems (e.g., Inform, Architect, Central Designer)
- Experience with Oracle databases and SQL/PL-SQL
- Experience working in regulated clinical development environments
Technical & Functional Skills
- Strong understanding of clinical database design, eCRFs, edit checks, and data validation
- Experience in programming data logic, integration workflows, and data transfer processes
- Knowledge of clinical data standards, regulatory requirements, and GxP/ICH guidelines
- Familiarity with end-to-end clinical data lifecycle and data cleaning processes
- Exposure to tools and approaches supporting automation, data workflows, and process optimization
Digital & Innovation Capabilities
- Demonstrated awareness of emerging digital capabilities, including automation and AI, and their potential application within clinical data management
- Ability to identify opportunities to improve processes using data-driven and automation approaches, while ensuring compliance within regulated environments
Core Skills
- Strong problem-solving and analytical thinking skills
- Effective communication and ability to present technical concepts clearly
- Strong collaboration and stakeholder engagement skills
- Ability to work independently and manage multiple priorities
- Strong attention to detail and commitment to quality and compliance
- Willingness to learn and adopt new processes and te
Required Skills:
Adaptability, Adaptability, Automation, Clinical Database Programming, Clinical Databases, Clinical Data Management, Clinical Development, Clinical Informatics, Clinical Research, Communication, Data Analysis, Data Cleansing, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Medical Terminology, Operational Efficiency, Oracle Database, Project Coordination, Project Planning, Proven Commitment, Regulatory Requirements, Stakeholder Engagement {+ 1 more}
Preferred Skills:
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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:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Job Posting End Date:
07/10/2026
*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.
