Lilly Associate / Sr. Associate - Trial Capabilities Belgium in Cork, Ireland
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 35,000 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.
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 and activities related to 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.
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), 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
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
Effective communication, negotiation, and problem solving skills
Self-management and organizational skills
Language Capabilities: French and/or Dutch/Flemish
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