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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.

Responsible for the operational management of LTS and biomarker samples in Long Term Sample Storage and/or for assigned clinical studies in the portfolio, as well as data generated from them per established process and procedures. Ensure appropriate language is included in protocol, informed consent, and regulatory documents for assigned trials. Partners with the Clinical Laboratory Associates for assigned trials to ensure that clinical samples used in exploratory analysis are collected, stored, shipped and processed in a timely manner, to meet the objectives defined in clinical study protocols. Manage the operations for LTSS Inventory: storage, use, and disposal over the life cycle of the sample.

Primary Responsibilities:

Biomarker Sample Management

+ Partners across clinical laboratory sciences to ensure that LTS/biomarker samples are appropriately collected, stored, and timely shipped to the labs processing/storing them, to ensure consistent execution of sample processing, analysis and timely data delivery for assigned trials.

+ Facilitates issue resolution or needs as it relates to LTS/biomarker sample management. Provide technical and logistical consultation for assigned trials as it relates to biomarker sample management processes.

+ Communicate effectively and escalate issues appropriately.

+ Proactively monitor for issues and trends as it relates to LTS/biomarker sample management. Partner with the clinical laboratory associates to provide input into ICF, protocol development, and trial operations as it relates to biomarker sample management.

+ Responsible for tracking biomarker samples from clinical studies, as well as data generated from them, keeping an updated sample/data inventory for samples in Long Term sample storage and/or assigned clinical studies. Utilize software tools to track inventory of LTS/biomarker samples, analyze trends, and build metrics.

+ Resolve and appropriately escalate issues related to sample quality. Develop and implement processes ensuring that all required testing is well-defined and documented within supporting systems to facilitate the effective application of biomarker strategies.

+ Partners with clinical operations, clinical lab associates and data managers to reconcile possible inconsistencies between LTS/biomarker samples, data, inventories, and clinical data.

+ Develop, implement, improve, and provide training on sample use processes and consent operations for LTS/biomarker samples.

+ Utilize software tools to track inventory of LTS/biomarker samples.

+ Provide peer coaching and training as it relates to LTS/biomarker sample management.

+ Identify opportunities for process optimization and shared learning.

+ Model the Lilly core values and behaviors.

Minimum Qualification Requirements:

+ Bachelor’s degree

+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Other Information/Additional Preferences:

+ Experience in clinical research, clinical development or laboratory operations

+ Familiarity with biomarkers and sample types

+ Degree in a scientific field

+ Understanding of the role of clinical biomarkers in drug development

+ Ability to link laboratory strategies to biomarker sample management

+ Laboratory professional certification through an accrediting body, such as the American Society for Clinical Pathology (ASCP)

+ Good working knowledge of ICH, FDA, GDPR, and GCP regulations and guidelines

+ Familiarity with biomarker assay global regulatory requirements. Ethical and regulatory guidance as pertaining to biospecimens particularly consent. Deep understanding of ICFs.

+ Technical experience with data transfers (DTS/DTA), data analytics, data visualization and dashboard builds, LIMs/sample tracking systems, design and UAT.

+ Effectively partner cross functionally to deliver results

+ Strong Communication Skills (Verbal And Written)

+ Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.

+ Excellent organizational skills with high attention to detail

+ Domestic and international travel (10%), required

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $148,500

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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