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. This position supports the development, maintenance, and continuous improvement of our proprietary Electronic Data Capture (EDC) platform, used across medical device clinical trials.

Success in this role requires someone who brings foundational clinical research experience, an aptitude for database and system logic, and the curiosity and adaptability to partner across Data Management and Software Development.

This is not an entry‑level role, but rather a growth‑oriented opportunity for candidates who have established a foothold in clinical data or clinical technology and want to deepen both.

• 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.

• Translate Data Management needs into actionable tickets, requirements, or feature requests.
• Support form testing, CRF logic verification, and data query workflows.
• Assist data managers in day‑to‑day use of the system to ensure accuracy and efficiency.

• 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.

• 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.

• Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field.

• 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, Open Clinica, or homegrown).
• Familiarity with Microsoft Azure tools (Azure SQL, Azure Dev Ops, Functions).

• 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.

• 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.

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.