LEM Study Coordinator

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.

The Laboratory for Experimental Medicine (LEM) group oversees internally supported and outsourced immunogenicity and related biomarker assays in support of clinical studies. LEM is part of the broader ADME, Toxicology and PK/PD division within Lilly. The Study Coordinator, in partnership with lab scientists and analysts, will provide support for ongoing studies and projects to ensure on-time data deliverables. The individual will perform a myriad of study and project coordination and operational support activities to proactively enable the planning, preparation, analysis, and reporting of clinical samples. This includes logistical, quality control, LIMS support, and select scientific aspects of the operations. The Study Coordinator will provide operational and logistical support to internal sample analysis teams and operations project teams, including lab scientists and analysts, operations associates, and Clinical Lab Services (CLS) associates, to ensure smooth study execution and timely data delivery.

Study Coordinator FTE Key Responsibilities:

• Provide project management support to internal sample analysis and operations project teams, helping to track timelines, manage deliverables, and drive accountability across study activities. Collaborate with cross-functional teams to support operational troubleshooting, oversight, and logistical coordination for study execution.
• Author, prepare, and maintain key study documentation, including protocols, reports, and standard operating procedures, in alignment with regulatory standards.
• Support process improvement initiatives by finding opportunities for efficiency gains and implementing best practices to enhance data management and study coordination.
• Work with the scientists to manage Immunogenicity and Biomarker assay validation and sample analysis activities. 
• ​Coordinate laboratory operations for internal sample analysis and validation activities ensuring regulatory compliance and study efficiency
• Manage specimen tracking and data integrity for internal analysis, oversee specimen shipments, and ensure timely data uploads into the LIMS system
• Perform QC activities ensuring accuracy and integrity of assay data and associated documentation.
• Maintain notebooks, LIMS, and appropriate documentation as outlined in Lilly Research Laboratories (LRL) and LEM procedures and policies and in accordance with applicable regulatory compliance requirements.
• Coordinate lab and QC activities using LIMS, electronic laboratory notebooks, and other relevant software to support efficient study execution and data management
• Facilitate communication between project leaders, lab scientists and operations to ensure timely data delivery

Minimum Requirements

• Bachelor's degree in a basic science field with at least 2 years of relevant experience
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Experience in processes from sample collection instructions/shipping/receipt through data reporting, as well as ancillary infrastructure processes.   
• Experience in Regulatory Audit interactions
• Experience with various assay platforms and multiple computer software applications as they relate to immunogenicity and biomarker assays
• Experience working in a laboratory setting
• Exceptional organizational skills with the ability to assess the status of multiple projects and adapt to changing priorities and requirements
• Strong interpersonal skills — ability to build relationships with internal and external partners while demonstrating initiative and adaptability
• Excellent oral and written communication skills with high attention to detail and accuracy in documentation and data management
• Experience in a regulated (e.g. GLP, GCP, GMP, etc.) environment, specifically related to a bioanalytical (immunogenicity, biomarkers and/or PK) environment, with a focus on large molecules and newer modalities - ELISA applications.
• Proven project management and operations expertise.  Must be able to support multiple projects and meet timelines while maintaining compliance. 
• Experience in demonstrating process effectiveness/success as well as determining when improvements are needed.
• Proficient in project and lab management software such as Jira, Watson, and Signals

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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