Clinical Data Programmer

Clinical Data Programmer - Bangalore, India (Officebased)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

The Clinical Data Programmer – DMW is responsible for designing, developing, transforming, and validating clinical study databases and data models within CDMS, DMW, and CDW. The role supports end‑to‑end clinical data management, SDTM deliverables, process improvement, automation initiatives, and cross‑functional collaboration to ensure high‑quality and compliant clinical trial data.

What You Will Be Doing:

Study Database Setup

• Build and configure studies in CDMS based on protocol requirements.
• Develop and test validation/derivation checks; perform UAT.
• Implement blinding rules and manage TMF‑required documentation.
• Provide technical input on protocol, EDC requirements, and study documents.

DMW Model Configuration & Data Transformation

• Create DMW trials, mapping specifications, and external data models.
• Perform SDTM staging/model transformations and execute data loads.
• Configure filewatchers and update transformations as needed.
• Review eCRFs and DCM annotations to ensure metadata alignment.

SDTM & Programming Deliverables

• Map data across CDMS → DMW → CDW → SCE for SDTM dataset generation.
• Develop, validate, and QC programs supporting data accuracy and reporting.
• Support define.xml, aCRF, SDRG, and final SDTM package preparation.

Process Excellence & Standards

• Share best practices, lessons learned, and contribute to standards adoption.
• Support process optimization, documentation updates, and change management.
• Collaborate with cross‑functional teams to enhance efficiency and automation.

Stakeholder Collaboration

• Partner with Data Managers, Biostats, IT, Central Monitoring, and external CROs/vendors.
• Communicate effectively across functions; provide documentation and training as required.
• Resolve technical issues collaboratively and manage conflicting viewpoints professionally.

Your Profile:

• M.Sc/B.Sc in Life Science, Computer Science, IT, or related field.
• 5 years’ pharma experience in DMW, LSH, Veeva
• Hands‑on experience with CDASH, CDISC, SDTM, and clinical data systems.
• Strong knowledge of GxP, clinical development processes, and project coordination.
• Experience working with global, cross‑functional teams.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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