Trial Capabilities Associate
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
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 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-8223.
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.
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