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.
Organization Overview:
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 1500 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 44 nationalities.
Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business. And so, the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions including Customer Meeting Services, Global HR Data Management, Medical Information, Procurement, Trial Capabilities, Global Scientific Communications and more to come on stream.
The TA (Therapeutic Area) Associate, Clinical Laboratory Sciences will have early engagement with the appropriate study team, business and therapeutic partners on development of the clinical laboratory, diagnostic and biomarker strategies at the trial level. The TA associate coordinates vendor activities for assigned trials as well as facilitates research and resolution to any clinical laboratory and diagnostic issues or needs throughout the life of the trial. They partner with the clinical team to provide input into the protocol development/design, develop and implement the integrated trial clinical laboratory plans and the review and monitoring of resultant data, ultimately providing high quality, combinable data in a cost effective and timely fashion.
The Lilly CLS organization is unique within the pharmaceutical industry in that it is a standalone function that specializes in managing and overseeing all lab and diagnostic deliverables for Lilly’s entire clinical portfolio. In an effort to bring additional capacity and flexibility to deliver on this rapidly expanding portfolio of medicines, CLS is excited to announce that we are expanding our team in Cork, Ireland. By centralizing many aspects of CLS’ lab and diagnostic support activities in Cork, we will now be able to offer expanded hours of coverage across Europe and Asia to better support our internal clinical development partners who manage studies from outside of North America.
Responsibilities:
1. Portfolio Strategy, Planning and Delivery
- Provide complete clinical laboratory, ECG, imaging, sample storage and other clinical diagnostic support as
- needed for assigned trial(s)
- Provide expertise and consultation relating to clinical laboratory, ECG, imaging, sample storage and other
- diagnostic biomarkers, including assay development and validation.
- Provide technical and logistical consultation regarding clinical laboratory, ECG, imaging, sample storage and
- other diagnostic biomarker issues and services
- Provide input and review of the protocol related to clinical laboratory and diagnostic needs
- Provide and oversee clinical testing plans and study risk oversight as it pertains to clinical labs, diagnostic
- data reviews, and lab managements plans.
- Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment
2. Project Management
- Escalate issues as warranted to upper management
- Proactively be monitoring for issues and trends
- Drive clinical laboratory data completeness and accuracy within business systems
- Drive communications to prospectively manage upcoming cross-functional activities, key milestones, and decisions
- as well as to proactively identify updates to schedule and partner with clinical to optimize timeline
- Articulate the value of clinical laboratory solutions in terms of reliability, time, cost, quality and scalability
- Monitor trial budgets and ensure FRAP compliance
- Maintain accurate budget information and defined protocol testing in the Laboratory and Diagnostic tool
- Maintain inspection readiness at all times by maintaining a complete eTMF (electronic Trial Master File) at a trial level
- Keep study team abreast of trial specific metrics and issues
3. People Development
- Participate fully in the performance management process
- Model the Lilly core values and behaviours
- Provide peer coaching within the organization that fosters inclusion and innovation, continual improvement, and an
- external awareness and understanding
Basic Requirements:
- Bachelor’s degree in a science or related life sciences field
Additional Skills/Preferences:
- Knowledge of clinical drug development
- Prior laboratory experience or knowledge of laboratory testing
- Strong self-management skills
- Strong teamwork and interpersonal skills
- Strong communication skills (verbal and written)
- Conceptual understanding of information technology
- Strong organizational skills
- Negotiation skills
- Detail oriented
- Clinical trial experience preferred
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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