Expert Specialist - Clinical Development Apply
Locations: Ireland, Cork
Time Type: Full time
Posted On: Posted Yesterday
Job Requisition ID: R-71021
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.
Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 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 marking. 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: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Purpose: The 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(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU).
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 Execution: Assist in the management of study budgets including the setup of purchase orders and e-requisitionsOrder, track, and ship study supplies, tools, and/or instrumentsTrack and report Regional/Global enrollment data for ongoing clinical studiesPerform routine study activities per policies/procedures (e.g. Study closeout)Participate in shared learning forumsMay assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.) 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, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexingSupport backroom for regulatory and mock inspectionsSupport collection and review of key information to support submission activities (i.e. 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, monitors and updates fields as study timelines or other information changes and troubleshoots illogical data.Assist in producing and distributing project status reportsCoordinate 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 experienceComputer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project) Highly Desired Skills: Strong communication skills; able to communicate clearly and succinctly with team members and leadershipDemonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skillsStrong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solvingAbility 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.
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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About Us At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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