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.

About us:

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 a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: En Able, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. En Able, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

• Come join our team
• Be Creative, Be an Innovator, and most of all, Be Yourself!

Purpose:

The purpose of the North America Maintenance Associate is to provide 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 and activities related to 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.

This is a 12 months fixed term contract.

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 Capabilities Responsibilities:

• 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
• Provide feedback and shared learning for continuous improvement
• Understand and comply with procurements, legal and financial requirements and procedures

Minimum Qualification Requirements:

• Bachelor’s degree preferably in a scientific or health related field
• Understanding of the overall clinical development paradigm
• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem-solving skills
• Organizational skills
• Other Information/Additional Preferences: Language capabilities

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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