Trial Capabilities Associate/Senior Associate/Manager- Project Management

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 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.

Purpose:

The Trial Capabilities Associate, Complete Trial Package (CTP) Project Manager is accountable to ensure the CTP required for Regulatory and Ethics committee submission includes all regulatory documents required for initial Clinical Trial application as well as any subsequent submissions as appropriate for or all participating countries globally. The associate is responsible for working across the CDDA functions, CMC, and other contributing functions to plan timely delivery of all required documents and track the delivery to ensure timely submission. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. The role will support trials being initiated in Phase I-IV across all therapeutic areas.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Clinical Trial Responsibilities

• Responsible for providing guidance to the study team regarding Lilly required and regulatory required documentation, processes, and other aspects of the complete trial package

• Partner with Design Hub, Clinical Development, CMC, Trial capabilities in all regions, and associated Third Party Organizations (TPOs) to ensure document requirements for each trial are defined, documented, and delivered within agreed upon timelines to allow on-time delivery of the complete trial package

• Create, update, and track document requirements and delivery in the regulatory document tracker at the trial level

• Communicate timelines with appropriate study team members and implement risk mitigation and contingency plan strategies on behalf of the study teams to ensure on-time document delivery

• Drive timelines-based study priority ensuring accelerated novel approaches are adopted for Game Changers and Potential Game Changers

• Escalate document delivery issues, as appropriate

• Responsible for initiating the insurance certificate process for all countries participating in the trial where applicable

• Responsible for ensuring all documents required from the global study team for initial country submissions are provided to the affiliates and TPO partners

• Responsible for the development and utilization of appropriate document delivery planning and tracking tool(s), serving as the owner of communication across the study team, affiliates and TPOs utilizing critical thinking and problem-solving skills to hold business partners accountable for delivery

• Populate internal systems to ensure accuracy of trial / site performance

• Understand, comply with, and promote complete trial package process improvements and technology systems as well as identify suggested process improvements

• Provide feedback and shared learning for continuous improvement

• Anticipate and monitor dynamically changing priorities

Minimum Qualification Requirements:

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred

• Applied knowledge of project management processes and skills

• Appreciation of / experience in compliance-driven environment

• Effective communication, negotiation, and problem-solving skills

• Self-management and organizational skills

Additional Preferences:

• Excellent communication (written and verbal) skills

• Strong knowledge of data privacy regulations, intellectual property, and clinical trial regulations

• Ability to make business-driven decisions.

• Understanding of the overall clinical development paradigm and the importance of efficient site activation

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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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