Senior Clinical Data Science Programmer – ICON Strategic Solutions
Location: India
Job ID: 2025-121459
Portfolio: Biometrics
Work Type: Remote
About ICON
ICON is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We deliver innovative solutions to support clinical development globally.
Role Overview
The Senior Clinical Data Science Programmer will design, develop, validate, and manage clinical trials in EDC systems. This role serves as the subject matter expert (SME) for EDC-related activities, integrates clinical trial modules, and ensures high-quality delivery of clinical studies.
Key Responsibilities
Design, develop, and validate clinical trials within EDC systems.
Manage edit check specifications and configure trial-level edit checks.
Execute UAT scripts to test clinical study or EDC platform setup.
Configure different instances of studies (UAT, production, testing).
Facilitate user access requests for study teams.
Set up and manage blinded and unblinded study configurations in EDC.
Serve as SME for all EDC database-related activities at the trial level.
Configure, validate, and integrate other modules within the EDC ecosystem (e.g., coding, IRT, safety systems, local labs).
Troubleshoot database setup according to study needs.
Perform impact assessments and implement post-production changes.
Support adoption of new capabilities and business processes.
Liaise with clinical technology vendors to ensure milestones are met with quality.
Work with leadership to resolve issues or gaps affecting clinical trial delivery.
Lead technology vendor oversight and partner with team members, vendors, and CROs to manage risks.
Ensure archival and inspection readiness of Clinical Technology Trial Master File (TMF) documents.
Participate in submission readiness and represent Clinical Trial Configuration in inspections or audits.
Required Education & Skills
Bachelor’s degree (Life Sciences, Pharmacy, or related field).
Knowledge of drug development process.
Minimum 6 years’ experience in Data Management, Clinical Programming, or related clinical research fields, with at least 4 years in EDC programming.
Hands-on experience with Veeva (mandatory); experience with Medidata Rave, Oracle Inform, etc., is a plus.
Preferred experience in programming using CQL, CDB, JSON, and/or C#.
Experience integrating other clinical trial modules (e.g., lab, safety, IRT, coding) with EDC systems.
Understanding of industry-standard technologies supporting Clinical Development (CTMS, SAS, R, Python, Data Warehouses, SharePoint).
Benefits
ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:
Annual leave entitlements
Health insurance options for employees and families
Retirement planning benefits
Global Employee Assistance Programme (TELUS Health, 24/7 access to specialized professionals)
Life assurance
Flexible, country-specific optional benefits (childcare vouchers, gym memberships, travel passes, health assessments, etc.)
More details: ICON Careers Benefits
Diversity & Inclusion
ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Reasonable accommodations are available: Request here
Application Encouragement
Even if you don’t meet all requirements, you are encouraged to apply. You may be exactly what ICON is looking for.
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