Cloud Engineer

The Cloud Engineer  Clinical Trials is responsible for designing, building, and operating secure, scalable, and compliant cloud infrastructure that supports clinical trial systems and data platforms. This role plays a critical part in enabling reliable, validated, and inspection-ready cloud environments used across the clinical research lifecycle, while ensuring compliance with GxP, HIPAA, FDA, and global clinical trial regulations.  Cloud Engineer collaborates closely with Development, DevSecOps, Clinical Operations, Data Management, Quality, and Regulatory teams to ensure that cloud-based clinical systems are resilient, cost-effective, and aligned with regulated SDLC and validation requirements.

Key Responsibilities:

• Design, deploy, and maintain cloud infrastructure supporting clinical trial platforms (e.g., EDC, CTMS, eTMF, RTSM, data warehouses/lakes)
• Build and manage Infrastructure as Code (IaC) using tools such as Terraform, CloudFormation, ARM, or equivalent
• Implement cloud architectures aligned with GxP, CSV (Computer System Validation), and regulated SDLC best practices
• Ensure high availability, disaster recovery, backup, and business continuity for clinical trial systems
• Configure and manage cloud networking, storage, compute, and database services in validated environments
• Partner with DevSecOps and Security teams to implement IAM, encryption, logging, monitoring, and security controls
• Support system validation, change management, and documentation required for audits and inspections
• Monitor performance, capacity, and cost optimization of clinical trial cloud environments

Required

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field (or equivalent experience)
• 5 years of experience as a Cloud Engineer, Infrastructure Engineer, or similar role
• Hands-on experience with cloud platforms (AWS, Azure, and/or GCP) in regulated or highly controlled environments
• Strong knowledge of cloud networking, security, identity management, and data protection concepts
• Experience supporting GxP-regulated systems or healthcare/life sciences environments
• Proficiency with Infrastructure as Code and automation tools
• Familiarity with validation, change control, and documentation practices in regulated SDLCs
• Experience with scripting or automation (Python, Bash, PowerShell)

Preferred Qualifications

• Experience supporting clinical trial systems (EDC, CTMS, eTMF, CDMS, safety systems)
• Knowledge of FDA 21 CFR Part 11, Annex 11, and data integrity principles
• Experience with containerization and orchestration (Docker, Kubernetes) in regulated environments
• Familiarity with monitoring and observability tools (Cloud-native or third-party)
• Cloud certifications (AWS Solutions Architect, Azure Solutions Architect, GCP Professional Cloud Architect)
• Experience collaborating with Quality and Regulatory teams during inspections or audits