Technical Lead

Red Nucleus is hiring Technical Lead, iTakeControl to join our global team! 

Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves.  Our culture is about meaningful work, a true sense of community, and fun.  We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".    

How You Will Contribute

In this position, you will be working with our Clinical Research team. For more information, please visit ITC I Red Nucleus.

Job Overview
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.
The role begins with leading the technical handover from an external vendor and transitions into long-term in-house product development and ownership. This position carries technical decision authority, deep hands-on responsibility, and technical mentorship.

The role requires regular collaboration with US-based stakeholders, with extended overlap during vendor transition and critical releases.

Role Phases
Phase 1 – Vendor Transition & Stabilization
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.

Phase 2 – In-House Development & Product Evolution
Build and maintain ongoing features, platform improvements, optimizations, and provide technical mentoring within the established compliance framework.

Product Engineering Ownership
• Own the long-term technical health, stability, security, and evolution of the iTakeControl platform
• Lead the initial technical handover from the external vendor, including deep dives into codebase, architecture, AWS infrastructure, integrations, and data models
• Ensure a zero-downtime transition from vendor to in-house ownership
• Establish and maintain in-house development workflows, environments, and technical standards post-transition
• Maintain clear, current technical documentation including architecture diagrams, integration points, dependencies, and system design
• Act as the technical point of accountability for the product within approved compliance boundaries

Hands-On Full-Stack Development
• Write production-quality code daily across frontend, backend, and database layers
• Maintain and enhance the React application using modern patterns (Hooks, Context API, state management) and accessible, responsive UI aligned to clinical workflows
• Design, implement, and maintain backend services using Node.js, including RESTful APIs, authentication, authorization, validation, and error handling
• Maintain and extend existing audit logging, electronic signatures, and compliance-related functionality
• Design, optimize, and maintain relational databases (PostgreSQL or MySQL), including schema design, migrations, query optimization, and data integrity controls
• Maintain existing video upload, storage, streaming, and playback capabilities
• Troubleshoot production issues, optimize performance, and ensure system reliability

Technical Direction & Mentorship
• Serve as the technical authority for the iTakeControl platform
• Review all code changes for quality, security, performance, and compliance
• Provide architectural guidance and design reviews
• Mentor and technically guide 4–5 full-stack engineers on React, Node.js, AWS, and development within regulated systems
• Establish and enforce coding standards, testing practices, security guidelines, and documentation expectations
• Proactively identify technical debt, risks, and improvement opportunities and drive resolution
Platform Operations, Cloud & Compliance
• Work strictly within the existing validated GxP-compliant system, preserving validation status
• Follow established change control processes for all technical changes
• Collaborate with QA on validation activities including IQ / OQ / PQ as required
• Ensure ALCOA+ data integrity principles and complete audit trails are maintained
• Develop new features in alignment with existing GxP, HIPAA, and FDA 21 CFR Part 11 frameworks
• Partner with a dedicated DevOps engineer to:
          o Review and guide AWS infrastructure designs (EC2, S3, RDS, CloudFront, SNS, IAM, VPC)
          o Define and validate CI/CD pipelines suitable for validated environments
          o Review Infrastructure-as-Code implementations (Terraform or CloudFormation)
• Ensure encryption at rest and in transit, secrets management, monitoring, alerting, and compliant deployments with rollback and post-deployment verification

Required Technical Expertise
Core Technical Skills
• 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

Regulatory & Compliance Knowledge
• 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

Education & Experience
Education
• Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field

Required Experience
• 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

Other Information:
This job description has been designed to capture the essential functions of this job. It was not designed to contain or be interpreted as a comprehensive inventory of all the duties, responsibilities and qualifications required to perform this job. It is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling, or staffing needs.

What You Will Enjoy at Red Nucleus

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

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit.  We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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