At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader. Our employees 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.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across various business functions.
Our premium workspace offers flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking.
In-house People Development services, Educational Assistance, and wellbeing initiatives enhance the career experience for our colleagues.
Our commitment to diversity, equity, and inclusion ensures inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender.
The purpose of this role is to provide clinical trial capabilities in support of clinical development.
As an Associate, you will ensure investigator sites meet requirements to support ongoing activities during site maintenance and close-out.
You will be responsible for obtaining clinical trial authorizations and ethical approvals for study changes and activities related to records management.
Additionally, you will ensure inspection readiness through a complete, accurate, and readily available Trial Master File.
* Leverage trial prioritization to manage all site maintenance requests to drive timelines aligned with company priorities.
* Communicate directly with sites to maintain an active collaboration with sites during maintenance and close-out.
* Manage any site level changes (change of Principal Investigator, Sub-Investigator, and/or site location change).
* Anticipate and monitor dynamically changing priorities. Facilitate Site Level Informed Consent Form updates resulting from amendment/addenda, Investigator Brochure update, etc.
* Facilitate approval of additional patient-facing materials throughout the trial (site-specific recruitment material, patient-facing retention material, patient reimbursement, etc.).
* Complete site close-out verification activities.
* Maintain an active collaboration with sites during maintenance and close-out.
* Address requests related to the Clinical Study Report.
* Maintain eTMF inspection-ready.
* Identify, communicate, and resolve issues; collaborate with peers and cross-functional partners as needed to ensure effective site management.
* Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
This role requires a Bachelor's degree preferably in a scientific or health-related field.
You should have an understanding of the overall clinical development paradigm, appreciation of/experience in compliance-driven environments, and effective communication, negotiation, and problem-solving skills.
Language capabilities are also a plus.