Hybrid Clinical Database Programmer

at ICON plc

• Job title: Clinical Database Programmer
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Cloud, Google Cloud Platform, SDLC
• Location requirements: Hybrid, Bangalore, India

About the role

• Lead Clinical Database Programmer working in clinical development at ICON plc, managing clinical databases for oversight of clinical trials and ensuring data quality and efficiency.

Responsibilities

• Lead and manage clinical database programming activities for multiple studies of varying complexity, ensuring adherence to established processes, standards, timelines, and quality expectations.
• Design, develop, test, and maintain clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.
• Provide study-level technical support and mentorship to junior team members, resolving complex technical issues and evaluating alternative solutions.
• Create, review, and approve technical specifications and develop complex programs and technical solutions for data management systems.
• Support database build activities including eCRFs, change requests, edit checks, derivations, custom functions, interface configurations, and data migrations.
• Track and manage issues within Medidata applications, working collaboratively with vendors and escalating risks as appropriate.
• Support user access management via iMedidata and Cloud Administration.
• Assist in the management and maintenance of medical coding dictionaries, including MedDRA and WHODrug.
• Resolve data anomalies and quality issues, ensuring compliance with regulatory and internal quality standards.
• Contribute to the development of departmental documentation, including training materials, SOPs, work instructions, and process guides.
• Continuously seek opportunities to improve processes, templates, and tools to enhance efficiency, scalability, and data quality.
• Maintain comprehensive supporting documentation to ensure traceability, inspection readiness, and compliance.
• Capture and communicate lessons learned, best practices, and frequently asked questions.
• Oversee CRO/vendor activities related to outsourced data management systems, ensuring compliance with industry best practices, quality standards, and timelines.
• Maintain regular communication with external partners, proactively addressing issues and mitigating risks.
• Collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, Safety, Medical, and IT.
• Help end users understand technical challenges and analyze current processes to ensure solutions are fit-for-purpose and aligned with study needs.
• Contribute to system selection, implementation, and enhancement initiatives.
• Support delivery across approximately 18–20 studies per year.

Requirements

• Bachelor’s degree in computer science, Life Sciences, or a related field.
• 8+ years of experience in the pharmaceutical, biotech, or CRO industry.
• 6+ years of hands-on experience in clinical trial database design and management using Medidata Rave, including Custom Function programming.
• Strong experience with eCRF design, database specifications, and data validation checks.
• Experience with QC, UAT, platform testing, and development/execution of test scripts.
• Solid understanding of the Drug Development Process, SDLC, Computer System Validation, FDA regulations, ICH-GCP, and global Health Authority guidelines.
• Proven experience supporting clinical data development, validation, execution, maintenance, and documentation for regulatory submissions.
• Experience working in Agile or hybrid development environments.
• Strong verbal and written communication skills with the ability to collaborate across global, cross-functional teams.
• Demonstrated ability to prioritize and manage multiple studies and deliverables.
• Familiarity with JReview and Business Objects.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.