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.
