Clinical Trials System Analyst

12 month DRC Contract (€300-€350/day)

2 days a week onsite in Cork - mandatory

This role sits within the Systems Operations team, focusing on Clinical Trials Systems. The primary objective is to manage the day-to-day operations of systems, ensuring technical reliability, data integrity, and regulatory compliance.

Responsibilities

• System Maintenance: Develop a deep working knowledge of clinical trial systems and data workflows while providing daily support for system queries and incidents.
• Deployment & Testing: Assist in installing new system releases and patches, supporting testing activities, and documenting business processes.
• Risk Management: Identify, log, and escalate system risks; apply root cause analysis to prevent the recurrence of issues.
• Change Management: Support system updates, stakeholder communications, and transition activities.
• Compliance: Support internal audits and external inspection readiness.
• Resource Development: Create and maintain user-facing materials such as job aids, FAQs, and training documentation.
• Data Integrity: Perform data movement activities and associated quality checks to ensure accuracy.
• Collaboration: Partner with cross-functional teams and external vendors across various geographies.
• Feedback & Metrics: Capture customer feedback on usability and develop operational metrics to monitor system health.

Technical Focus Areas

• Operational Support: Managing daily queries and staying informed on regional regulations and signature requirements.
• Release Coordination: Handling system testing and associated technical documentation during updates.
• Data Quality: Executing checks to ensure compliance and accurate data movement.
• Knowledge Management: Maintaining a robust knowledge base to drive system adoption.

Requirements

• Education: Bachelor's degree in Computer Science, IT, or equivalent professional experience.
• Industry Knowledge: Applied experience in clinical drug development, clinical information flow, or quality/medical environments.
• Problem Solving: Strong analytical skills with the ability to diagnose issues and anticipate stakeholder needs.
• Communication: Ability to explain technical issues clearly to both technical and non-technical audiences.
• Organization: Proven ability to manage multiple tasks simultaneously in a fast-paced environment.
• System Configuration: Hands-on experience configuring systems while maintaining data integrity standards.
• Technical Exposure: Familiarity with clinical data management processes or clinical drug development systems.