IRT Setup and Implementation Specialist
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 38 nationalities who deliver innovative solutions that add value across a variety of business service functions including finance, information technology, medical, clinical trials and more.
Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking.
In-house people development services, educational assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Come join us today and be a part of our dynamic team!
The Role
GBS Lilly Management Team is currently looking for a customer-focused and quality-centric IRT setup and implementation colleague to join its new team in Cork.
This individual will be an exceptional professional, who consistently exceeds expectations, thrives in a challenging and dynamic work environment, and will be an active contributor to our team.
Roles and responsibilities include execution of the study set-up process and ensuring the IRT is configured and functions according to approved customer requirements.
This position requires strong collaboration with other business partners to ensure successful IRT execution and compliance.
Key Responsibilities:
* Consultation, study set-up and execution: 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:
o Strong understanding of study-specific system requirements.
o Executing the study set-up process from requirements approval thru implementation.
o Creating study-specific documents including clinical-trial site IRT/IWRS user tools.
o Ensuring timelines are met according to agreed-upon system-need dates.
Maintain Operational Excellence
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.
Requirements
Bachelor's degree or higher.
Applied experience in quality, clinical drug development, clinical systems or clinical information flow, preferred.
Additional Preferences:
* 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.