Senior Manager - Full Stack Developer - Clinical Data Operation

Responsibilities

• Design and manage a centralized clinical reporting platform to consolidate data management and vendor reconciliation outputs into a single governed reporting layer.
• Build and maintain Clean Patient Tracker applications providing real-time access to CRF completion, visit status, and data queries.
• Develop executive-level dashboards highlighting portfolio-wide KPIs such as query aging, protocol deviations, and data entry lag.
• Partner with Data Management and external vendor teams to establish structured data ingestion pipelines for EDC and reconciliation reports.
• Collaborate with Clinical Sciences, Biostatistics, and Safety teams to develop validated self-service analytical tools.
• Drive automation across routine reporting workflows, including scheduled data ingestion and alert-based notifications.
• Ensure GCP compliance, inspection readiness, and robust audit trail management for all reporting solutions.

Requirements

• 8+ years of experience in Clinical Data Management or clinical trial operations.
• Minimum 3+ years focused on clinical data reporting, analytics, or reporting tool development.
• Hands-on experience with Medidata Rave EDC, including query management workflows and dataset structures.
• Proficiency in Python frameworks such as Dash, Streamlit, or Flask.
• Demonstrable experience with Power BI, Tableau, and SQL for analytical dataset development.
• Solid understanding of CDISC CDASH/SDTM standards and GxP/CSV validation principles.
• Bachelor’s or Master’s degree in Computer Science, Data Science, Bioinformatics, or a related field.

Preferred Qualifications

• Advanced degree (MBA/MS) in a relevant quantitative field.
• Strong UX/UI design sensibility for building intuitive reporting tools for non-technical users.
• Experience working with clinical data lakes and complex vendor reconciliation feeds.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to translate science into medicine has led to numerous FDA-approved treatments. We are dedicated to pioneering innovative approaches to science, manufacturing, and commercialization to redefine our understanding of health.