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We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our employees worldwide 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.
Fixed Term Role
The Trial Capabilities Team provides clinical trial capabilities in support of clinical development.
The Clinical Trial Start-Up Associate is accountable for ensuring investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out.
Responsibilities
Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, and serve as the point of contact for a site's IRB and Competent Authority.
Communicate directly with sites to enable start-up and maintain active collaboration 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/IRB engagements to efficiently drive new work.
Populate internal systems to ensure accuracy of trial/site performance.
Understand and comply
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