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Lilly
Associate - Clinical Laboratory Sciences
Indianapolis
FULL TIME
October 10, 2024
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
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Provide support through expertise and consultation relating to clinical laboratory, ECG, imaging, sample storage and other diagnostic biomarkers, including assay development and validation.
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Provide technical and logistical consultation for assigned trial.
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Provide input and review of the protocol related to clinical laboratory and diagnostic needs.
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Provide and coordinate clinical testing plans and study risk oversight as it pertains to clinical labs, diagnostic data reviews, and lab management plans.
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Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment
2. Project Management
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Raise issues as warranted to upper management
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Proactively be monitoring for issues and trends
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Drive clinical laboratory data completeness and accuracy within business systems
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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
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Articulate the value of clinical laboratory solutions in terms of reliability, time, cost, quality and scalability
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Monitor trial budgets and ensure FRAP compliance
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Maintain accurate budget information and defined protocol testing in the Laboratory and Diagnostic tool
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Maintain inspection readiness at all times by maintaining a complete e TMF at a trial level
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Keep study team abreast of trial specific metrics and issues
3. People Development
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Model the Lilly core values and behaviors
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Provide peer coaching within the organization that fosters inclusion and innovation, improvement, and an external awareness and understanding
Basic Qualification and Requirements
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Bachelor’s degree
Additional Skills
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Knowledge of clinical drug development and/or clinical trial experience preferred
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Prior experience in pharma, diagnostics or CRO environment preferred
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Prior laboratory experience or knowledge of laboratory testing
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Strong self-management skills
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Strong teamwork and interpersonal skills
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Strong communication skills (verbal and written)
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Conceptual understanding of information technology
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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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