Sr Associate IS Engineer

Role Overview

The Sr. Associate IS Engineer – CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation.

Roles & Responsibilities

• Design, develop, and maintain software applications aligned with clinical trial registration and regulatory submission needs
• Ensure system performance and availability for critical business applications such as Disclose and docuBridge
• Manage project scope, risks, and timelines to ensure successful software delivery
• Translate conceptual ideas into working code for rapid and effective development
• Apply SDLC principles to drive efficient software development processes
• Utilize ITIL and ITSM processes for reliable IT service delivery
• Work with business stakeholders to translate functional needs into data and technical requirements
• Provide technical guidance and mentoring to junior developers
• Collaborate with vendor partners on ETL pipelines (primarily Databricks / AWS) to support the disclosure platform
• Ensure complete and correct data flow from internal systems to Disclose
• Conduct User Acceptance Testing (UAT) and validate performance and data integrity
• Develop solutions using innovative technologies, including generative AI
• Maintain code quality through testing strategies including unit and integration tests
• Create and maintain technical documentation for architecture, deployment, disaster recovery, and operations
• Analyze functional and technical requirements and translate them into software architecture specifications
• Maintain ongoing application support and ensure smooth, continuous operations
• Implement system monitoring tools and dashboards to track health, availability, and performance
• Conduct root cause analysis and implement preventative measures
• Ensure the implementation of system security measures to protect against threats and unauthorized access

Basic Qualifications

Must-Have Skills

Good-to-Have Skills

Professional Certifications

Soft Skills

Skills Required

Fda, Databricks