Clinical Data Systems Specialist

About the role

The Clinical Data Systems Associate is an early-career, hybrid clinical–technical role designed for individuals who can bridge clinical data workflows with technology, systems thinking, and hands-on software validation.

Responsibilities

• System Support & Troubleshooting
• Identify, document, and triage system issues or user-reported bugs in the in-house EDC platform.
• Support the implementation and verification of fixes and enhancements with Software Development.
• Perform initial root-cause analysis for Azure-based issues before escalating.
• Clinical Data Workflow Support
• Translate Data Management needs into actionable tickets, requirements, or feature requests.
• Support form testing, CRF logic verification, and data query workflows.
• Aid data managers in day-to-day use of the system to ensure accuracy and efficiency.
• Documentation & Testing
• Create and execute test scripts as part of system validation and release cycles.
• Maintain accurate system documentation, user guides, and training resources.
• Log issues, enhancements, and validation activities in alignment with QA processes.
• Cross-Functional Collaboration
• Participate in regular Software-DM syncs to stay aligned on priorities and release plans.
• Deliver user training and frontline support for clinical study teams.
• Serve as a liaison between operational users and the technical team.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field.
• Required Experience: 1–3 years in clinical data management, clinical systems support, clinical research technology, or software QA within a clinical research environment.
• Exposure to EDC platforms (REDCap, Medidata, OpenClinica, or homegrown).
• Familiarity with Microsoft Azure tools (Azure SQL, Azure DevOps, Functions).
• Preferred Qualifications: Prior experience with software testing, QA processes, or system validation; Experience collaborating with both technical and clinical teams; Experience with clinical workflow analysis or system optimization work.

Skills

• Understanding of FDA 21 CFR Part 11, ICH-GCP, and clinical data documentation standards.
• Basic understanding of relational databases and structured data (SQL a plus).
• Strong communication, documentation discipline, and cross-team collaboration abilities.
• High attention to detail and strong organization in a fast-moving environment.
• Ability to perform User Acceptance Testing (UAT) to ensure new features and fixes meet intended requirements.

Location and Travel Requirements

This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc.