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 1,600 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.
Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies, and on-site parking. In-house 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Responsibilities Trial Leadership and Regional Operational Knowledge: Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials:Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed to meet the deliverables of the trial.Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.Assess, identify and monitor trial-level risks. Create an integrated trial-level risk mitigation and contingency plan.Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants using financial tracking tools.Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure.Be accountable for trial/regional enrollment strategy and execution.Manage relationships and serve as a single point of contact for trial communication.Apply problem-solving skills to daily issues with cross-functional study team.Identify and assist in developing continuous improvement activities.Manage TPO qualification process, selection, and oversight.Clinical Trial Process Leadership and Expertise: Demonstrate understanding of drug development process and inter-relatedness of cross-functional activities.Be knowledgeable of the global and regional operating model.Single point of accountability for the Trial Master File.Network and leverage expertise to anticipate trial and regional issues.Demonstrate ability to lead and influence in the midst of ambiguity.Coach peers, cross-functional team members and TPOs.Apply expertise and knowledge of global/regional regulations and Good Clinical Practice (GCP).Scientific Expertise: Leverage scientific and regulatory knowledge to prepare technical consultation for clinical and regulatory documents.Combine scientific clinical trial operational knowledge to impact clinical trial design.Utilize clinical development knowledge, problem solving, and critical thinking skills.Minimum Qualification Requirements: Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience; or an advanced degree.Highly Desired Skills: Applied knowledge of trial execution methodology, processes, and tools.Demonstrated ability to work cross-culturally with global colleagues and TPOs.Ability to influence without authority.Strong leadership and networking skills.Effective and influential communication, self-management, and organizational skills.Demonstrated ability to manage complex situations through problem-solving.Flexibility to adjust to altered priorities.If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process.
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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