Lilly Associate/ Sr Associate- Clinical Trials North America Maintenance 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.
About us: This role is located in our Cork GBS Office Little Island
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals. There we boast a vibrant workforce made up of over 35 nationalities, speaking over 27 languages.
Established in 2010 to gain efficiencies in Finance GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions.
This, along with the current physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! The new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings.
Our benefits package includes healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, Educational Assistance, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more..
Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food
The North America Maintenance Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to support ongoing activities during site maintenance and close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals for study changes, execution of any amendment to the budget and contract, and activities related to clincial finance and records management. 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: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Clinical Trial Responsibilities
Leverage trial prioritization to manage all site maintenance requests to drive timelines aligned with company priorities
Manage any site level changes (change of Principal Investigator, Sub-Investigator and/or site location change)
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.)
Negotiate and execute budget and contract amendment driven by protocol changes
Support investigator payments to resolve invoice-related queries
Complete site close-out verification activities
Maintain an active collaboration with sites during maintenance and close-out
Communicate Unblinded Treatment Assignments to sites
Address requests related to the Clinical Study Report
Ensure TMF Functional Check Placeholders are closed
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
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
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
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
Language Capabilities (all work done in English, another language may be appreciated)
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 ( LillyRecruitingCompliance@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.