Associate Clinical Trial Project Manager-Diabetes
As a Clinical Trial Project Manager (CTPM) Associate, you will lead 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. You will utilize your experience to 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. Responsibility and activities for this role include:
Project Management, and Regional Operational Knowledge
Clinical Trial Process Leadership and Expertise
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.
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.
- Bachelors 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.
- 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
- Minimum of 3 years clinical trial experience in the medical device industry with a strong working knowledge of the clinical research process
- Working knowledge of regulations, standards, and guidelines related to medical device clinical studies
- 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
- 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.