Heart Rhythm Clinical Research Solutions · 11 hours ago
Clinical Data Systems Specialist
Heart Rhythm Clinical Research Solutions is a full-service CRO focused on transforming data into evidence for better care. The Clinical Data Systems Specialist role is designed for individuals who can bridge clinical data workflows with technology, supporting the development and maintenance of the Electronic Data Capture platform used in clinical trials.
Health CareMedicalMedical Device
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
Qualification
Required
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
Preferred
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