Clinical Data Systems Specialist

This is a fully remote position, open to applicants in Alabama.

📋 Description

• Identify, document, and prioritize system issues or bugs reported by users in the internal EDC platform.

• Assist in the implementation and verification of fixes and enhancements in collaboration with the Software Development team.

• Conduct preliminary root-cause analysis for issues related to Azure before escalating them.

• Convert Data Management requirements into actionable tickets, specifications, or feature requests.

• Aid in form testing, verify CRF logic, and manage data query workflows.

• Develop and execute test scripts as part of system validation and release processes.

• Ensure accurate maintenance of system documentation, user manuals, and training materials.

• Engage in regular sync meetings with Software and Data Management teams to align on priorities and release schedules.

• Provide user training and frontline support to clinical study teams.

⛳️ Requirements

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

• 1–3 years of experience in clinical data management, clinical systems support, clinical research technology, or software QA within a clinical research context.

• Familiarity with EDC platforms such as REDCap, Medidata, OpenClinica, or proprietary systems.

• Knowledge of Microsoft Azure tools including Azure SQL, Azure DevOps, and Functions.

• Understanding of FDA 21 CFR Part 11, ICH-GCP, and standards for clinical data documentation.

• Basic knowledge of relational databases and structured data; SQL experience is a plus.

• Excellent communication skills, strong documentation practices, and the ability to collaborate across teams.

• High attention to detail and exceptional organizational skills in a dynamic environment.

• Capability to conduct User Acceptance Testing (UAT) to confirm that new features and fixes fulfill intended requirements.

🏝️ Benefits

• Occasional domestic travel may be necessary for company meetings, audits, and other events.