Clinical Trial Project Manager

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.

Associate, Clinical Trial Project Manager (CTPM)

Purpose

The Clinical Trial Project Manager (CTPM) 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 CTPM 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Project Management and Regional Operational Knowledge

• Use project management skills, processes and tools to develop and execute local, regional and / or global clinical trials as described below :
• Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.
• Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.
• Risk - 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.
• Budget - Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.
• Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator training
• 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, including issue management, contingency planning and issue resolution.
• 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 to and from the Clinical Development, CDDA, and Third Party Organization (TPOs).
• Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates / regions, global team members and other business partners).
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Manage TPO qualification process, selection, and oversight.

Clinical Trial Process Leadership and Expertise

Scientific Expertise

Minimum Qualification Requirements

Other Information / Additional Preferences

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https : / / careers.lilly.com / us / en / workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

#WeAreLilly

Skills Required

Ms Excel, Project Management, Ms Project, Ms Powerpoint