Senior Programmer / Lead CDS Developer (AI & Automation)

Job DescriptionSenior Programmer / Lead CDS Developer (AI & Automation)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 ResponsibilitiesClinical Database Delivery & Execution (40%)Oversees and coordinates clinical database activities across multiple clinical programsInterfaces with CDS leadership to ensure consistency of technical strategies and executionPlans and manages timelines to ensure on-time delivery of database-related activitiesCollaborates with study teams, stakeholders, and vendors to translate requirements into deliverablesDatabase Development & Programming (20%)Designs, develops, and maintains clinical databases and data transfer files according to specificationsPrograms and validates edit checks, derivations, and scripts supporting data ingestion and integrationLeads and participates in review of eCRFs, edit checks, and database build activitiesEnsures adherence to standards, SOPs, and process guidelinesTraining, Mentorship & SME Support (20%)Trains new hires and supports ongoing capability development across the teamActs as a subject matter expert for troubleshooting, issue resolution, and best practicesPromotes a high-quality, customer-focused, and collaborative working environmentInnovation, Process Improvement & Digital Enablement (15%)Leads and participates in task forces, system evaluations, and CDS technical initiativesContributes innovative solutions to enhance processes and increase productivitySupports the evaluation and adoption of improved ways of working, including appropriate use of automation and data-driven approachesDemonstrates 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 areasAligns with CDS leadership to ensure consistency of approach across programsQualifications, Skills & ExperienceEducationBachelor’s degree in computer science, mathematics, science, or a related field (or equivalent experience)Experience4–7 years of clinical database development and/or data programming experienceStrong experience with clinical data management systems (e.g., Inform, Architect, Central Designer)Experience with Oracle databases and SQL/PL-SQLExperience working in regulated clinical development environmentsTechnical & Functional SkillsStrong understanding of clinical database design, eCRFs, edit checks, and data validationExperience in programming data logic, integration workflows, and data transfer processesKnowledge of clinical data standards, regulatory requirements, and GxP/ICH guidelinesFamiliarity with end-to-end clinical data lifecycle and data cleaning processesExposure to tools and approaches supporting automation, data workflows, and process optimization.Digital & Innovation CapabilitiesDemonstrated awareness of emerging digital capabilities, including automation and AI, and their potential application within clinical data managementAbility to identify opportunities to improve processes using data-driven and automation approaches, while ensuring compliance within regulated environments.Core SkillsStrong problem-solving and analytical thinking skillsEffective communication and ability to present technical concepts clearlyStrong collaboration and stakeholder engagement skillsAbility to work independently and manage multiple prioritiesStrong attention to detail and commitment to quality and complianceWillingness to learn and adopt new processes and technologiesRequired 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: Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:07/3/2026*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.