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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 39,000 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 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.
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. o 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 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 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) o Partner with Regional Operatioins to achieve regional enrollment goals.
Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the CPM Organization, Regional Clinical Operations, 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
Demonstrate understanding of drug development process. Acknowledge inter-relatedness of crossfunctional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.
Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time.
Network and leverage 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.
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.
Leverage 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.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree
Minimum of 3 years clinical trial experience with a strong working knowledge of the clinical research process prior clinical trial site-level or affiliate experience
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Applied knowledge of project management methodology, processes and tools
Demonstrated ability to work cross-culturally with global colleagues and with TPOs
Ability to influence without authority
Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
Effective 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
Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint)
Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
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.