Trial Capabilities Associate/Senior Associate/Manager- Project Management

<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>Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across <span>60 nationalities</span> who deliver innovative solutions that add value across a variety of <span>Business Service</span> functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little <span>Island, complete</span> with flexible hybrid working options, healthcare, pension and life <span>assurance benefits,</span> subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ </p><p>wellbeing initiatives are just some of the holistic benefits that enhance the <span>career experience</span> for our colleagues.</p><p></p><p>Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural <span>backgrounds, generations,</span> sexuality, visible and invisible disabilities and gender, with four <span>pillars: EnAble,</span> embRACE, LGBTQ+ &amp; Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access <span>Lilly initiative</span> to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability <span>confident culture</span> both at Eli Lilly Cork and beyond. </p><p></p><p>Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!</p><p></p><p><b>Purpose:</b></p><p></p><p>The Trial Capabilities Associate, Complete Trial Package (CTP) Project Manager is accountable to ensure the CTP required for Regulatory and Ethics committee submission includes all regulatory documents required for initial Clinical Trial application as well as any subsequent submissions as appropriate for or all participating countries globally. The associate is responsible for working across the CDDA functions, CMC, and other contributing functions to plan timely delivery of all required documents and track the delivery to ensure timely submission. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. The role will support trials being initiated in Phase I-IV across all therapeutic areas.</p><p></p><p><b>Primary Responsibilities: </b></p><p></p><p><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. </span></p><p></p><p><b>Clinical Trial Responsibilities</b></p><ul><li><p>Responsible for providing guidance to the study team regarding Lilly required and regulatory required documentation, processes, and other aspects of the complete trial package</p></li><li><p>Partner with Design Hub, Clinical Development, CMC, Trial capabilities in all regions, and associated Third Party Organizations (TPOs) to ensure document requirements for each trial are defined, documented, and delivered within agreed upon timelines to allow on-time delivery of the complete trial package</p></li><li><p>Create, update, and track document requirements and delivery in the regulatory document tracker at the trial level</p></li><li><p>Communicate timelines with appropriate study team members and implement risk mitigation and contingency plan strategies on behalf of the study teams to ensure on-time document delivery</p></li><li><p>Drive timelines-based study priority ensuring accelerated novel approaches are adopted for Game Changers and Potential Game Changers</p></li><li><p>Escalate document delivery issues, as appropriate</p></li><li><p>Responsible for initiating the insurance certificate process for all countries participating in the trial where applicable</p></li><li><p>Responsible for ensuring all documents required from the global study team for initial country submissions are provided to the affiliates and TPO partners</p></li><li><p>Responsible for the development and utilization of appropriate document delivery planning and tracking tool(s), serving as the owner of communication across the study team, affiliates and TPOs utilizing critical thinking and p