You 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. You will 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. You 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.
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 management plans.
Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment
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 at a trial level
Keep study team abreast of trial specific metrics and issues
Participate fully in the performance management process
Model the Lilly core values and behaviors
Provide peer coaching within the organization that fosters inclusion and innovation, continual improvement, and an external awareness and understanding
Internal Number: 50034
About Eli Lilly & Company
Company Overview 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 39,000 employees worldwide 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.