Lilly Trial Capabilities Associate 1 in Seoul, South Korea
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.
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
Manage investigator payments and any other financial transactions related to Trial Capabilities which include, but not limited to, vendor creation and management, PO creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution
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
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
Anticipate and monitor dynamically changing priorities
Understand and comply with procurements, legal and financial requirements and procedures
Understand, comply, and reinforce local regulations and guidances, Lilly Medical policies and procedures, and good clinical practices (GCP)
IND/IRB submission of initial packages and amendment(s)
Site Management support (manage many aspects of ongoing study conduct including IP and non-IP supplies)
Inspection readiness of regulatory documents and processes
Site budget/contract development and management
Leadership and Process Improvement
Regulatory(MFDS) Technical Knowledge
TMF (essential documents) management at a site/country level
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!