Job Summary:
• We are seeking an experienced deployment, and enhancement of a Clinical Risk Monitoring platform used to support clinical trial oversight and Risk-Based Quality Management (RBQM) activities. This individual will serve as the technical lead for an offshore development team and oversee a junior developer while driving architecture, development standards, deployment, and support activities.
• The ideal candidate will possess strong R Shiny development expertise, hands-on experience working with clinical trial data, and experience managing application deployments in regulated life sciences environments.

Responsibilities:
• Design, develop, test, deploy, and maintain enterprise-level R Shiny applications supporting clinical trial oversight and risk monitoring.
• Act as technical lead for a small development team and provide guidance, mentoring, code reviews, and technical direction to a junior developer.
• Build interactive dashboards, reports, and analytic solutions utilizing clinical trial data.
• Collaborate with Clinical Operations, Data Management, Biostatistics, and business stakeholders to define requirements and deliver solutions.
• Manage application deployment activities and support production releases.
• Administer deployment environments and ensure application availability, scalability, and performance.
• Maintain code repositories and establish best practices around source control, release management, testing, and documentation.
• Support RBQM initiatives through the creation and enhancement of monitoring tools and risk analytics.
• Develop and optimize SQL queries, stored procedures, and integrations with clinical data repositories.




• Participate in validation activities and documentation supporting regulated environments as required.
• Troubleshoot application issues and provide ongoing production support.
• Evaluate emerging technologies, including AI-enabled solutions, to enhance platform capabilities.

Experience:
• Bachelor's degree in Computer Science, Statistics, Data Science, Life Sciences, or a related field.
• 5+ years of hands-on R development experience.
• 5+ years of R Shiny application development experience.
• Experience working within pharmaceutical, biotechnology, CRO, or clinical research environments.
• Direct experience working with clinical trial data.
• Experience deploying and supporting production R Shiny applications.
• Experience managing source code repositories using Git or similar tools.
• Robust understanding of SDLC processes.
• Strong communication and stakeholder management skills.
• Ability to lead technical activities and oversee junior developers. Nice to Have:
• Experience with Azure cloud environments.
• Experience with Posit Connect (RStudio Connect), Shiny Server, or similar deployment platforms.
• Experience with SQL Server, Azure SQL, or other relational databases.
• Experience supporting Clinical Risk Monitoring or RBQM programs.
• Knowledge of clinical trial metrics, KRIs, and quality oversight processes.
• Experience integrating APIs and external data sources.
• Experience supporting GxP or validated environments.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Exposure to AI, machine learning, predictive analytics, or agent-based technologies.

📌 Technical Lead(R Shiny Development) (India)
🏢 System Soft Technologies
📍 India