Clinical Trial Project Management

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 35,000 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.

The Clinical Trial Project Manager (CTPM) Associate leads 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 uses 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 results.

Primary Responsibilities:

Project Management and Regional Operational Knowledge

• Use project management skills, processes and tools to develop and implement 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 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 build one coordinated trial-level risk mitigation and contingency plan.

• Budget - Understand the cross-functional, trial-level budget components. Build 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 partner 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.

• 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 study team (including with vendors, affiliates/regions, global team members and other business partners).

• Identify and assist in developing process improvement activities based on meaningful trends such as industry, regulatory, new technology, etc.

• Manage TPO qualification process, selection, and oversight.

Clinical Trial Process Leadership and Expertise

• Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial expertise.

• Be knowledgeable of the global and regional operating model; coordinate and facilitate geographic and functional input to provide to the study teams.

• Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development

• Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.

• Demonstrate ability to lead and influence in the midst of ambiguity and coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.

• Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.

• Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.\

Scientific Expertise

• Demonstrate scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.

• Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.

• Apply clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.

Basic Qualifications

• Bachelors degree

• At least one year of clinical research experience

Additional Skills/Preferences

• Applied knowledge of project management methodology, processes and tools

• Demonstrated ability to work cross-culturally with global colleagues and with TPOs

• Ability to empower without authority

• Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects

• Inclusive and influential communication, self-management, and organizational skills

• Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity

• Flexibility to adjust to altered priorities

• Clinical trial experience with a strong working understanding of the clinical research process.

• Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS PowerPoint)

• Ability to travel periodically
  

Lilly is an EEO/Affirmative Action Employer and 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.