Sr Programmer / Lead CDS Developer (AI & Automation)

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)

Requirements

• 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:
• Preferred Skills:
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Additional Information

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.

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