Trial Capabilities Associate (계약직)

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 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 various internal and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out
• Site budget/contract development and management
• Manage investigator payments and any other financial transactions
• Identify, communicate, and resolve issues
• Coordinate the management and delivery of clinical trial material
• 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
• Inspection readiness of regulatory documents and processes

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