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 serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
The 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 Associate coordinates vendor activities for assigned trials as well as facilitates research and solution 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 real-time fashion.
Primary Responsibilities
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
Portfolio Strategy, Planning and Delivery
Provide support through 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 for assigned trial.
Provide input and review of the protocol related to clinical laboratory and diagnostic needs.
Provide and coordinate 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
2. Project Management
Raise 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
3. People Development
Model the Lilly core values and behaviors
Provide peer coaching within the organization that fosters inclusion and innovation, improvement, and an external awareness and understanding
Basic Qualification and Requirements
Bachelor’s degree
Additional Skills
Knowledge of clinical drug development and/or clinical trial experience preferred
Prior experience in pharma, diagnostics or CRO environment preferred
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
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 is an EEO/Affirmative Action Employer and 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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