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.
Skills: e-consent clinical systems clinical trials system support system migration