Job Title: Senior Clinical Data Science Programmer
Company: ICON Strategic Solutions
Location: India (Remote)
Portfolio: Biometrics
Job ID: 2025-121459
Hiring Manager: Kalpana Kulasekaran
As a Senior Clinical Data Science Programmer, you will join the world’s largest and most comprehensive clinical research organization, leveraging healthcare intelligence to design, manage, and validate clinical trials.
EDC & Clinical Trial Setup:
Design, develop, and validate clinical trials in EDC systems.
Manage edit check specifications and configure trial-level edit checks.
Execute UAT scripts to test study or EDC platform setup.
Configure study instances (e.g., UAT, production, testing).
Facilitate user access requests for study teams.
Set up and manage blinded and unblinded study configurations.
Serve as SME for all EDC database activities at the trial level.
Integrate EDC with other clinical trial modules (lab, safety, IRT, coding).
Troubleshoot database setups as per study requirements.
Perform impact assessments and implement post-production changes.
Collaboration & Vendor Management:
Drive adoption of new capabilities and business processes.
Serve as the contact for Clinical Technology vendors to ensure milestone delivery.
Work with leadership, technology vendors, and CRO partners to resolve risks.
Lead technology vendor oversight and ensure trial readiness for audits and inspections.
Documentation & Compliance:
Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.
Participate in preparation for regulatory submissions and represent the Clinical Trial Configuration group during formal inspections.
Bachelor’s degree.
Knowledge of drug development processes.
Minimum 6 years of experience in Data Management, Clinical Programming, or related Clinical Research fields, including at least 4 years in EDC programming.
Hands-on experience with Veeva (mandatory); experience with Medidata Rave, Oracle Inform, etc., is a plus.
Programming experience in CQL, CDB, JSON, or C# preferred but not required.
Experience integrating EDC with other clinical trial modules (lab, safety, IRT, coding, etc.).
Familiarity with industry-standard technologies to support Clinical Development (e.g., CTMS, SAS, R, Python, Data Warehouses, SharePoint).
Competitive salary with diverse benefits focused on well-being and work-life balance.
Annual leave entitlements, health insurance, retirement planning, life assurance, and employee assistance programs.
Flexible, country-specific optional benefits (childcare vouchers, gym discounts, travel subsidies, etc.).
Inclusive and accessible work environment; commitment to equal opportunity employment.
More info on benefits: ICON Careers Benefits
Reasonable accommodations: ICON Reasonable Accommodations
ICON is committed to inclusion, belonging, and a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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