Clinical Data Systems Specialist

Summary

Heart Rhythm Clinical Research Solutions (HRCRS) is a full-service CRO model powered by real-world evidence. The Clinical Data Systems Specialist role is designed for individuals who bridge clinical data workflows with technology, supporting the development and maintenance of the proprietary Electronic Data Capture platform used in clinical trials.

Responsibilities

• 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
• 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

Skills

• 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, OpenClinica, or homegrown)
• Familiarity with Microsoft Azure tools (Azure SQL, Azure DevOps, 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

Qualifications

Must Haves

• 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, OpenClinica, or homegrown)
• Familiarity with Microsoft Azure tools (Azure SQL, Azure DevOps, 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

Nice to Haves

• 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

Benefits

• Fully remote position (may be performed anywhere within the United States of America).
• Early‑career, hybrid clinical–technical role.