Expert Specialist

Overview
At Lilly, we unite caring with discovery to make life better for people around the world.
We are a global healthcare leader with teams across the world focused on delivering life-changing medicines, improving disease management, and supporting communities through philanthropy and volunteerism.
We are looking for people who are determined to make life better for people around the world.
Eli Lilly Cork is made up of a diverse team of over 2000 employees across 60 nationalities delivering innovative solutions 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, 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 wellbeing initiatives enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI) and supports all dimensions of inclusion with pillars EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Purpose
The Expert Specialist /Sr.
Expert Specialist provides technical and project administrative support to the Clinical Development Trial Lead (CDTLs) to help enable on-time and on-budget delivery of key tasks during clinical trial execution.
The Expert Specialist/ Sr.
Expert Specialist supports trial, asset, and portfolio level tasks that may be assigned to a specific asset team or centrally across a Therapeutic Area (TA) / Business Unit (BU).
Primary Responsibilities
Assist in the management of study budgets including the setup of purchase orders and e-requisitions
Order, track, and ship study supplies, tools, and/or instruments
Track and report Regional/Global enrollment data for ongoing clinical studies
Perform routine study activities per policies/procedures (e.g. Study closeout)
Participate in shared learning forums
May assist with other trial level activities as needed (e.g., coordination of regional and trial project-related meetings, newsletter structure, uploading minutes to study collaboration sites or eTMFs as appropriate)
Clinical Trial / Submission Documentation
Support and partner with CDTLs and Management to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites), including quality reviews and indexing
Support backroom for regulatory and mock inspections
Support collection and review of key information to support submission activities (e.g. collecting and verifying accurate information for financial disclosures/1572 and OSI)
Establish, maintain, and use appropriate team information repositories (e.g. study collaboration site; eTMF) and maintain project team rosters
Support filing and archiving processes
Clinical Trial Systems Management
Accurately input study timelines and other trial-level required fields into clinical trial database, monitor and update fields as study timelines or other information changes
Assist in producing and distributing project status reports
Coordinate with CDTLs and Management to generate regional-level, trial-level and compound-level milestone and budget reports, enrolment reports, and other reports as needed
Minimum Qualification Requirements
Two-year degree or 2 years administrative or technical experience
Computer proficiency and experience using Microsoft Word, Excel, PowerPoint, Project
Highly Desired Skills
Strong communication skills; able to communicate clearly and succinctly with team members and leadership
Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills
Strong teamwork and interpersonal skills including ability to adapt to changing business needs, attention to detail, self-management, organizational skills, and problem solving
Ability to maintain confidentiality
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 () 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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