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Purpose of the Job:

The Clinical Diagnostic Laboratory (CDL) implements clinical and translational biomarkers to support clinical development. This function requires specialized knowledge to manage quality generation, storage, compilation, and reporting of CLIA and GCP regulated data. Data Associates in the CDL are responsible for providing leadership and ownership of data generated by laboratory systems in the CDL. The Data Associate possesses an in depth understanding of data collection, data flow management, data quality, data technology, data set delivery, data archiving and data standards as it relates to regulatory requirements. This includes supporting qualification and maintenance of Instrument Controllers, Scripting processes for data movement and provide LIMS/LIS integration support.

Key Responsibilities of Job:

Data integrity related to special biomarkers – Data Associates will be responsible for ensuring that data generation, storage and transfer processes are following relevant regulatory standards. Associates act as single point of contact for requirements definition, strategy communication and deliverable acceptance for data provided to diagnostics partners and regulatory agencies.

Data Integration – Data Associates will be responsible for supporting software tools used by Scientists and CDL Leadership to use to better analyze, evaluate and report data generated in the CDL and at times combining it with other data sets. This will require knowledge of the bench science the related assay workflows and excellent relationships with the dedicated scientific staff.

Application of regulatory requirements – Data Associates will effectively apply specialized diagnostics knowledge and in depth understanding of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, FDA, ICH, Privacy, Diagnostics, CLIA).

Data Standards – Associates will drive standards decisions, implementation, and compliance for potential diagnostics. Differing data standards and collection platforms will be collected and combined for potential regulatory submission.

Lab Automation- Data Associates will be responsible for supporting and/or implementing and maintaining LIMS system to provide CDL with sample management, reagent management and process management capability. Additionally, when liquid handling automation is introduced into the lab, Data Associates will be tasked with assisting in programming and qualifying the automation to meet CDL needs and working with the scientific staff to validate assays/processes using the automation.

Communication and information management - Associates will define data management processes. Data Associates will lead the selection, evaluation, validation and implementation of data management and data visualization tools to organize, analyze and summarize data.

Technical writing skills – Data Associates are required to author methods, reports, standard operating procedures (SOPs) and other documentation. The associate will also present data to various groups and contribute to reports, regulatory documents, manuscripts, posters, etc.

Technical process application and improvement – Data Associates develop and use expertise and knowledge of instrument data storage, analysis, and archiving. Associates are responsible for configuration, security and qualification of instrument controllers and computer systems. Associates may also use this knowledge to provide trouble-shooting assistance to vendor partners.

Minimum Requirements:

Bachelor’s degree in a Core Science or Information Sciences related degree or equivalent experience.

Strongly Preferred:

• Experience working with CAP/CLIA and GCP data/validation requirements and network structure.
• Experience working with a LIMS/LIS Experience in sample management workflows
• Previous laboratory bench experience desirable.
• At least one year of regulated laboratory data experience.
• Proficient in Excel querying/scripting and spreadsheet validation process
• Knowledgeable in deploying different data transfer strategies that embrace
• Project Management skills. Ability to influence change and implement process improvement.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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