Clinical Data Systems Specialist

Heart Rhythm Clinical Research Solutions (HRCRS) is hiring a Clinical Data Systems Specialist to support and improve its proprietary EDC platform for medical device clinical trials. The role bridges clinical data workflows and technology through system troubleshooting, testing and validation, documentation, user training, and collaboration with Data Management and Software Development.

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

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

Software testing

QA processes

System validation

Clinical workflow analysis

System optimization

Cross-functional collaboration

Benefits

Fully remote position; may be performed anywhere within the United States of America.

Company

Clinical research CRO services and real-world evidence studies

Birmingham, Alabama, USA

https://www.hrcrs.com/

11-50 employees

Qualifications

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

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

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

****1–3 years**** in clinical data management, clinical systems support, clinical research technology, or software QA within a clinical research environment.

Required skills

Clinical data management, Electronic Data Capture (EDC), REDCap, Medidata, OpenClinica, Microsoft Azure, Azure SQL, Azure DevOps, Azure Functions, FDA 21 CFR Part 11, ICH-GCP, SQL, User Acceptance Testing (UAT), Software testing and system validation

Experience

1-3 years