Expert Specialist /Sr. Expert Specialist, Clinical Development

<p>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.</p><p></p><p><span><span>At Eli Lilly Cork, 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 45,000 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 patients around the world.</span></span></p><p><br/><span><span>Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across <span><span>60 nationalities</span></span> who deliver innovative solutions that add value across a variety of <span><span>Business Service</span></span> functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little <span><span>Island, complete</span></span> with flexible hybrid working options, healthcare, pension and life <span><span>assurance benefits,</span></span> subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ <br/>wellbeing initiatives are just some of the holistic benefits that enhance the <span><span>career experience</span></span> for our colleagues.</span></span></p><p><br/><span><span>Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural <span><span>backgrounds, generations,</span></span> sexuality, visible and invisible disabilities and gender, with four <span><span>pillars: EnAble,</span></span> Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access <span><span>Lilly initiative</span></span> to make our physical and digital environment accessible and inclusive for all. </span></span><span><span>Together they are committed to promoting awareness to create a disability <span><span>confident culture</span></span> both at Eli Lilly Cork and beyond. </span></span></p><p><br/><span><span>Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!</span></span></p><p>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(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU).</p><p>Primary Responsibilities<span>: 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.</span></p><p></p><p><b>Clinical Trial Execution </b></p><ul><li>Assist in the management of study budgets including the setup of purchase orders and e-requisitions</li><li>Order, track, and ship study supplies, tools, and/or instruments</li><li>Track and report Regional/Global enrollment data for ongoing clinical studies</li><li>Perform routine study activities per policies/procedures (e.g. Study closeout)</li><li>Participate in shared learning forums</li><li>May 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.)</li></ul><p></p><p> <b>Clinical Trial/Submission Documentation </b></p><ul><li>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 indexing</li><li>Support backroom for regulatory and mock inspections</li><li>Suppo