CTSS Intern

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.

Job Summary

The CTSS Intern will provide operational and administrative support to the Clinical Trial Site Service team under the guidance of experienced CTSS professionals. The role involves supporting trial documentation management, regulatory submission preparation, safety mailing activities, and general administrative tasks. In addition, the intern will assist the team in leveraging AI tools and automation solutions to support document handling, data processing, and workflow efficiency, contributing to continuous process improvement and digital enablement within the CTSS function.

Key Responsibilities

• Support the setup, maintenance, and organization of  Trial Master Files (TMF) / eTMF at country and site level.
• Assist in filing and archiving trial documents to ensure completeness, accuracy.
• Support preparation of regulatory submission materials including Ethics Committee (EC) submission packages and Safety Mailing materials.
• Assist in preparation and organization of Safety Mailing reports and tracking of safety documentation.
• Support application of AI tools and automation for document handling, data consolidation, and efficiency improvement.
• Assist in basic data processing, reporting, and preparation of trackers or summaries.
• Provide general administrative support and perform other tasks as assigned by the CTSS team.

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 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.