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.
About Lilly: 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.
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 parking. 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!
Current openings in these therapeutic areas: Cardiovascular Metabolic Health
Neuroscience
Immunology
Oncology.
Purpose:
The Clinical Development Trial Lead (CDTL) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.
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.
Trial Leadership, and Regional Operational Knowledge - 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. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using financial tracking tools.Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables.Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).Manage relationships and serve as a single point of contact and central owner for trial communication.Apply problem-solving skills to daily issues with cross-functional study team.Identify and assist in developing continuous improvement activities based on important trends.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.Single point of accountability for the Trial Master File, working closely with functional record owners.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 on aspects of clinical trial process.Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation.Scientific Expertise - Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents.Combine scientific clinical trial operational knowledge, and process expertise to impact clinical trial design.Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.Minimum Qualification Requirements:
Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.
Highly Desired Skills: Applied knowledge of trial execution methodology, processes, and toolsDemonstrated ability to work cross-culturally with global colleagues and with TPOsAbility to influence without authorityStrong leadership and networking skillsEffective and influential communication, self-management, and organizational skillsDemonstrated ability to manage complex situations through problem-solvingFlexibility to adjust to altered prioritiesOther Information/Additional Preferences:
Need to travel periodically to AST/ ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums.
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