Clinical Trial Project Management

Indianapolis, Indiana
October 16 2019
Life Sciences
Position Type
Full Time
Organization Type
Job Type
Are you seeking a career that makes a difference in the world? Are you an innovative thinker who can craft strategic solutions to deliver a continuously changing portfolio? Do you seek the opportunity to demonstrate your scientific and operational knowledge to impact clinical trial design, feasibility and implementation? Have you prepared or provided technical support for clinical and regulatory documents? Do you have extraordinary problem solving skills to support scientific needs in business? We have the role for you if you are looking for your next career move.

As Clinical Trial Project Manager (CTPM) Associate, you will lead the cross-functional study team in the development and execution of clinical trials. You will be accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. This role requires strong project management skills, 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. You will work with diverse teams to apply creative solutions to daily issue. This will include opportunities to work with vendors, affiliates/regions, global team members and other business partners). Other experiences you will encounter in this role include:
  • Driving and coordinating local, regional and global, cross-functional study teams throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
  • Accountability for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)
  • 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 process expertise.
  • Acting as a 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.
  • Networking and using your expertise to anticipate trial and regional issues, identifying areas of process breakdown, assessing situations and proposing proactive approaches that reduce and/or mitigate risks that impact ability to deliver.
  • Demonstrate ability to lead and influence in the midst of ambiguity.
  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.

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. #WeAreLilly

Basic Qualifications

  • Bachelors degree (scientific or health-related field) with at least 1 year of experience in a clinical setting or an advanced degree (MS, MSN, MPH, PharmD, PhD)

Additional Information

Ability to travel (up to 10% is expected- varies dependent on responsibilities)

EEO Statement: 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.

Additional Skills/Preferences

  • Applied knowledge of project management methodology, processes and tools (eg: Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint)
  • Solid ability to work cross functional and cross-cultural with global colleagues and with TPOs with strong leadership, networking skills and ability to influence without authority.
  • Effective and influential communication, self-management, and organizational skills
  • Demonstrated ability to handle 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
  • Prior clinical trial site-level or affiliate experience
  • Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings