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Consultant-Clinical Trial Project Mgmt

Indianapolis, Indiana

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Req ID 55505 Title Consultant-Clinical Trial Project Mgmt City Indianapolis State / Province Indiana Country United States Region North America

Company Overview

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.
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Responsibilities

Are you passionate about providing leadership in the development of clinical research? If you are experienced in innovation, strategy, and process optimization and are ready to join a world class team, this may be a potential opportunity for you.

At Lilly, the Clinical Trial Project Manager (CTPM) Consultant is responsible for using project management skills and processes to lead, influence cross-functional teams in the development and execution of complex global clinical trials across a development program and/or indication. The CTPM Consultant is accountable for the delivery of clinical milestones with quality and within scope and budget. This role incorporates scientific knowledge, trial process and regional expertise to anticipate and resolve complex and key technical operational or business problems with cross-functional study teams (including vendors, affiliates/regions, global team members, and other business partners) with little/no need for direct management support.

In this role, you will have an opportunity (not limited to) :
  • Foster relationships and serve as a single point of contact and central owner for trial communication across cross-functional study teams
  • Identify and assist in developing continuous process improvements based on experience and trends
  • Recognize inter-relatedness of cross-functional study team activities and understand the impact of project decisions
  • Look for opportunities to expand and deepen process expertise across teams, prioritize and make decisions on process and issues affecting study implementation and execution
  • Ensure inspection readiness
  • Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.
  • 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, external vendors and affiliates.
  • Execution and delivery of global clinical submission plans, including communications to team and leadership, resource and risk management
55505BR

Basic Qualifications

  • Bachelors degree and 5 years clinical research experience or equivalent experience in a scientific or health-related field

Additional Skills/Preferences

  • Applied knowledge of project management methodology, processes and tools
  • Proven ability to lead, coach and work effectively cross-culturally with global colleagues and with external vendors
  • 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 in a collaborative approach
  • Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships
  • Effective and influential communication, self-management, problem solving and organizational skills
  • Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating through ambiguity
  • Prior clinical trial site-level or affiliate experience
  • Prior experience with local/country or regional requirements

Additional Information

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

To submit resume, visit https://www.lilly.com/careers and apply to Req ID 55505.

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.

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