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.
Purpose: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.
Primary Responsibilities:Clinical Trial Responsibilities: 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.Minimum Qualification Requirements:Bachelor's degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred.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 - Fluency in English OR English and German.
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