Job Description

Senior 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 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 technologies

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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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/23/2026

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