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.
▪ Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ethics review board (ERB) and competent authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
▪ Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
▪ Communicate with Clinical Design, Delivery and Analytics (CDDA) functions and external party / clinical research organization to enable active collaboration during site activation, maintenance, and close-out.
▪ Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
▪ Identify, communicate, and resolve issues. Escalate issues to aligned management and quality as appropriate.
▪ Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
▪ Coordinate translation process for clinical trial documents and oversight of translation quality.
▪ Populate internal systems to ensure accuracy of trial / site performance.
▪ Populate Trial Master Files and libraries for future reference.
▪ Provide feedback and shared learning for continuous improvement.
▪ Be the ultimate responsible person in managing high priority (Game Changer, Potential Game Changer) and complex clinical trials or trials involving high number of investigator sites.
▪ Provide oversight of the submission status for the assigned studies and provide coaching and technical support to Associates/Specialists in managing the site-related trial capabilities activities for a study.
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.
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What We Do
Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment.
For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
