At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Our employees work together globally 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 believe in the talent of our workforce and aim to utilize and develop that talent by filling new positions within the company. If you are looking for a new role, you can view and apply to open positions posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have work authorization in the country where the position is located.
We strive to make a difference for people worldwide by discovering, developing, and delivering medicines that help people live longer, healthier lives. Our team at the Global Business Solutions centre in Cork boasts a diverse workforce made up of over 38 nationalities, speaking over 27 languages.
Job Overview
The Clinical Trial Project Manager (CTPM) Associate leads cross-functional study teams in the development and execution of clinical trials, ensuring quality, on-time delivery, and adherence to scope and budget. This role leverages project management expertise, regional operational knowledge, clinical trial process leadership, and scientific expertise to drive actions and coordinate efforts.
Main Responsibilities:
* Use project management skills and processes to develop and execute local, regional, and global clinical trials:
o Scope: Understand the scope of work required for successful clinical trial completion and monitor status, making changes as needed to meet deliverables.
o Timeline: Develop and track global trial enrollment plans, integrating inputs across functions and geographies.
o Risk: Assess, identify, and monitor trial-level risks, incorporating scientific knowledge, trial process, and regional expertise to create an integrated risk mitigation plan.
o Budget: Understand cross-functional, trial-level budget components and create/maintain overall budgets using financial tracking tools.
* Partner with organizations to coordinate Investigator Study Specific Training (ISSTs)/Affiliate Study Training (ASTs).
* Drive and coordinate local, regional, and global cross-functional study teams throughout study implementation, execution, and closure.
* Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
* Manage relationships and serve as single point of contact and central owner for trial communication with CPM Organization, Regional Clinical Operations, and Third-Party Organizations (TPOs).
* Apply problem-solving skills to daily issues with cross-functional study teams.
* Identify and assist in developing continuous improvement activities based on important trends.
* Manage TPO qualification, selection, and oversight.
Minimum Qualification Requirements:
* Bachelor's or University degree (scientific or health-related field preferred) and 3 years of clinical research experience or relevant experience in a scientific or health-related field; or advanced degree.
Highly Desired Skills:
* Applied knowledge of project management methodology, processes, and tools.
* Demonstrated ability to work cross-culturally with global colleagues and third-party organizations.
* Strong leadership and networking skills.
* Effective and influential communication, self-management, and organizational skills.
* Demonstrated ability to manage complex situations through problem-solving and critical thinking.
* Flexibility to adjust to altered priorities.