About the role

  • Technical Lead developing and evolving iTakeControl, a clinical trial patient engagement platform at Red Nucleus. Leading in-house product development with a focus on compliance and mentoring engineers.

Responsibilities

  • In this position, you will be working with our Clinical Research team.
  • The Technical Lead is a hands-on technical leader responsible for building, maintaining, and evolving iTakeControl, a clinical trial patient engagement platform operating within a validated GxP-compliant environment.
  • Lead structured handover from the external vendor, gain deep understanding of the existing system, ensure continuity, and establish in-house technical ownership within the validated environment.
  • Build and maintain ongoing features, platform improvements, optimizations, and provide technical mentoring within the established compliance framework.
  • Own the long-term technical health, stability, security, and evolution of the iTakeControl platform.
  • Write production-quality code daily across frontend, backend, and database layers.
  • Design, implement, and maintain backend services using Node.js, including RESTful APIs, authentication, authorization, validation, and error handling.
  • Troubleshoot production issues, optimize performance, and ensure system reliability.
  • Review all code changes for quality, security, performance, and compliance.
  • Mentor and technically guide 4–5 full-stack engineers on React, Node.js, AWS, and development within regulated systems.

Requirements

  • 10+ years of experience in full-stack web application development
  • 3+ years in a hands-on Technical Lead or Senior Engineer role
  • 2+ years providing technical leadership (code reviews, design guidance, standards enforcement) without formal people-management responsibility
  • 3+ years working within regulated or validated software environments
  • Proven experience taking over systems from external vendors or stabilizing legacy platforms
  • Experience in Life Sciences, Clinical Trials, Healthcare IT, or Medical Devices strongly preferred
  • Strong hands-on experience with Node.js and React
  • Advanced JavaScript / TypeScript, HTML5, CSS3, modern build tools and workflows
  • Strong relational database experience (PostgreSQL or MySQL)
  • Solid working knowledge of AWS services, security best practices, and cloud fundamentals
  • Experience contributing to CI/CD pipelines and Infrastructure-as-Code in production environments
  • Strong Git workflows and secure coding practices (OWASP Top 10)
  • Knowledge of AI concepts and practical application of AI-assisted development tools
  • Experience working in GxP-regulated, FDA-regulated, or HIPAA-compliant environments
  • Understanding of validation lifecycle, change control, and working within validated systems
  • Practical understanding of ALCOA+ principles and audit trail implementation
  • Familiarity with FDA 21 CFR Part 11 requirements for electronic records and signatures
  • Strong understanding of clinical data handling principles, including data integrity, traceability, privacy, and regulatory expectations within clinical trial systems

Benefits

  • Competitive pay, incentives, retirement, and income security programs
  • Comprehensive benefits and wellness programs focused on healthy lifestyles
  • Generous paid time off, employee assistance programs and flexible work arrangements
  • Performance driven environment including professional development and transfer opportunities
  • People first culture fostering self expression, diversity, and a growth mindset
  • Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
  • Support of the community organizations you are passionate about
  • Ongoing programs and events designed to bring our global team together

Job title

Technical Lead

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

HybridPuneIndia

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