Associate / Sr Associate - Clinical Information Systems (IRT)
Eli Lilly
- Cork
- Permanent
- Full-time
- Build and maintain effective business partnerships with clinical study teams and key functions.
- Understand system functionalities, including capabilities and limitations, for Lilly’s internal IRT/IWRS.
- Participate in Study Development Process to review study-specific protocol requirements and establish implementation timelines.
- Provide a validated study specific IRT/IWRS build that meets approved customer requirements.
- Ensure confidentiality and blinding is appropriately maintained at all times.
- Participate in all aspects of the System Development Cycle, including but not limited to:
- Strong understanding of study-specific system requirements.
- Executing the study set-up process from requirements approval thru implementation.
- Creating study-specific documents including clinical-trial site IRT/IWRS user tools.
- Ensuring timelines are met according to agreed-upon system-need dates.
- Sustain a culture of quality and compliance.
- Proactively identify ways to improve day-to-day activities and practices, and actively communicate opportunities to peers and leadership team.
- Participate in and/or support the implementation of local/divisional projects and other process improvement initiatives.
- Take proactive measures to avoid or reduce crises. When emergencies occur, identify root cause of issues, and communicate countermeasures and lessons learned.
- Demonstrate excellent project management abilities and strong understanding of IRT/IWRS processes.
- Troubleshooting configuration and execution problems (which could include logging formal incidents), identifying root causes, and implementing solutions.
- Bachelor’s degree or higher
- Applied experience in quality, clinical drug development, clinical systems or clinical information flow, preferred.
- Systems experience especially IRT/IWRS and/or electronic data capture.
- Understanding of clinical development and roles.
- Fluent in English.
- Self-motivated professional with excellent customer service and strong working/team building relationship skills.
- Proven interpersonal and communication skills.
- Demonstrates good judgment and is solution orientated.
- Ability to work independently and within a team environment.
- Strong organizational and multitasking capabilities.
- Attentive to details to ensure compliance and accurate reporting.
- Experience of working to tight deadlines.
- Flexibility in adapting to a non-routine and fast paced environment.