Trial Capabilities Associate

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 35,000 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. The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training. The associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. Responsibilities of this role include: 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 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 directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out Identify, communicate, and resolve issues Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems Leverage previous site / review board engagements to efficiently drive new work Populate internal systems to ensure accuracy of trial / site performance Understand and comply with procurements, legal and financial requirements and procedures Populate Trial Master Files and libraries for future reference Provide feedback and shared learning for continuous improvement Leverage trial prioritization Anticipate and monitor dynamically changing priorities Basic Requirements: Bachelor’s degree preferably in a scientific or health related field OR HS Diploma/GED with at least 5 years relevant clinical experience. Additional Skills and Preferences: Understanding of the overall clinical development paradigm and the importance of efficient site activation Applied knowledge of project management processes and skills Appreciation of / experience in compliance-driven environment Ability to learn and comply with financial and legal guidelines and policies (budget and contract) Effective communication, negotiation, and problem solving skills Self-management and organizational skills Language Capabilities Additional Information: Position location: Indianapolis, IN 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. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).