Associate-Trial Capabilities

Are you seeking a career that makes a difference in the world? Are you a creative thinker and have the ability to work with a dynamically changing portfolio? Does preparing a clinical trial site for patient enrollment and providing ongoing site support intrigue you? Do you have expertise in conducting clinical research and keeping up to date with country/regional regulatory standards? If so, we have the role for you.

North America Clinical Trial Capabilities supports clinical development, a critical component to Lilly's mission of delivering life-changing medicines. The Trial Capabilities Associate will partner with the team providing support to regulatory agencies, institutions and investigators through site budget, contract and informed consent negotiations, payments, and regulatory activities for clinical trials. Through partnerships, accurate planning, and timely execution all trial deliverables will be accomplished.

In this role you will have the opportunity to ….

• Initiate investigator site activities, including the collection and submission of regulatory documents, customization and negotiation of informed consent documents, resolution of issues, oversight of budgets, negotiation of contracts, ensure site compliance to required training and ensuring timelines are met.
• Communicate with clinical trial sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out activities.
• Work with business partners to achieve enrollment readiness by completing site activation processes.
• Continually maintain a state of inspection readiness and perform required duties for internal and external inspections.
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
• Connect with team members and continuously share insights across the organization.
• Develop communications regarding country and site level regulatory documentation, processes and other regulatory aspects of study conduct to Design Hub and appropriate business partners.
• Accurately populate Trial Master Files, IMPACT data, internal systems, and related libraries for future needs.
• Complete financial activities such as developing site budgets, purchase order creation, management, P2P processes related to payments, collection efforts for advanced and overpayments, and ensure completion financial reconciliation required for studies for CRF payments and invoiceables.
• Understand, comply, and reinforce local regulations, laws and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.

Company Overview

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 39,000 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.

Basic Qualifications

• Bachelor's degree preferably in a scientific or health related field or High School diploma/GED with at least 2 years experience in clinical research or related field
• 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.

Additional Information

• 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.

Additional Skills/Preferences

• Clinical research or relevant scientific experience preferred
• Applied knowledge of project management processes and skills
• Understanding of the overall clinical development paradigm
• Experience in a compliance environment
• Effective communication, negotiation and problem solving skills