Clinical Trial Project Management-Diabetes
The Clinical Trial Project Manager (CTPM) Consultant independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The CTPM Consultant consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of potential issues and resolution thereof.
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.
Leverage clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.
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 5 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 lead and work effectively cross-culturally with global colleagues and with TPOs
- Be recognized as a leader with demonstrated ability to coach others in process expertise.
- Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
- Ability to influence without authority
- Previous experience working in cross-functional teams/ projects and/or ability to establish and manage relationships
- Effective and influential communication, self-management, and organizational skills
- Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
- Minimum of 5 years clinical trial experience with a stong working knowledge in the medical device industry with a strong working knowledge of the clinical research process
- Prior clinical trial site-level or affiliate experience
- Prior experience with and working knowledge of regulations, standards, and guidelines related to medical device clinical
- Strong anylitical skills
- 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.