Senior IT Specialist - Technical Lead / Solution Architect

Job Position:Senior IT Specialist Technical Lead / Solution Architect



Location : Remote







Position Summary
The Senior Information Technology Specialist will serve as the senior technical lead and solution architect for OCS Data Central and associated data-management, data-quality, integration, and modernization capabilities. The position will translate FDA business and scientific requirements into secure, scalable, maintainable, and FDA-compliant technical solutions.





Key Responsibilities

• Provide technical leadership across the full application lifecycle: requirements analysis, system engineering, architecture, design, development, integration, testing, implementation, modernization, and maintenance .
• Lead modernization of OCS Data Central and interfaces with OCS/CDER systems, analytical platforms, repositories, and enterprise services.
• Architect automated data ingestion, validation, transformation, provisioning, workflow, exception-management, and reporting capabilities.
• Design scalable solutions supporting SDTM, ADaM, SEND and other clinical/nonclinical study data , metadata, and structured/unstructured information.
• Develop integration patterns using FDA-approved APIs, web services, databases, cloud services, and enterprise data platforms.
• Lead technical design reviews and ensure architecture complies with FDA-approved technologies, security requirements, and enterprise architecture standards .
• Establish DevSecOps, CI/CD, automated testing, configuration management, observability, recovery, and deployment practices using Government-approved technologies.
• Ensure solutions preserve data lineage, traceability, validation evidence, auditability, versioning, and controlled exception handling .
• Diagnose complex production and performance issues and provide technical direction to development and operations staff.
• Mentor IT Specialists and ensure technical documentation, system designs, interface specifications, runbooks, and knowledge artifacts remain current.

Minimum Qualifications

• 10+ years of experience across all phases of IT application software development, including high-level system engineering, user-needs analysis, system design, documentation, implementation, and maintenance, as required by the RFTOP.
• Demonstrated experience designing and modernizing enterprise data-intensive applications and integration architectures.
• Strong experience with databases/data warehouses, APIs, web applications, cloud architectures, data pipelines, automated testing, and DevSecOps.
• Experience with federal/FDA security, SDLC/EPLC, configuration management, and production systems preferred.
• Knowledge of clinical/nonclinical study-data standards and FDA regulatory data environments strongly preferred.
• Bachelor's degree in Computer Science, Information Technology, Engineering, or related technical discipline; advanced degree preferred.