Expert Specialist - Trial Capabilities

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 Expert Specialist is to provide technical support to Trial Capabilities in support of clinical development. The Expert Specialist is responsible for activities related to investigator sites readiness, maintenance and close out. The Expert Specialist will ensure inspection readiness through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional country-specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

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 may change over time and may include additional responsibilities not specifically described in the job description.

1. Assist investigator site activation activities, including compilation and submission/notification of regulatory documents.
2. Assist Trial Capabilities Associate on study document management & tracking for IRB/IEC submissions throughout the study.
3. Track site compliance to required training to effectively drive timelines aligned with company priorities.
4. Communicate directly with sites to enable start-up, as required, and maintain an active collaboration with sites during maintenance and close-out.
5. Coordinate translation process for clinical trial documents.
6. Manage/coordinate clinical trial system account request for investigator sites, as applicable.
7. Identify, communicate, and resolve issues.
8. Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems including maintaining systems and local tracking tools to allow tracking, performance metrics reporting and to meet Lilly and regulatory compliance requirements.
9. Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements.
10. Support inspection readiness through a complete, accurate and readily available Trial Master File including performing quality review periodically on documents related to Trial Capabilities.
11. Ensure sites receive Investigator Trial Master File (iTMF) before site initiation visit, as applicable.
12. Anticipate and monitor dynamically changing priorities.
13. Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP).

Minimum Requirements:
A degree or equivalent preferably in a scientific or health-related field.
Clinical research experience or relevant experience preferred.

Additional Skills/Preferences:

1. Good understanding of Good Clinical Practices (GCP).
2. Applied knowledge of project management processes and skills.
3. Appreciation of / experience in compliance-driven environment.
4. Ability to learn and comply with regulatory requirements and internal policies.
5. Effective communication, teamwork, and problem-solving skills.
6. Very good attention to details and accuracy.
7. Self-management and organizational skills.
8. Language Capabilities – English (read, write, conversation) and local language, as applicable.

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.

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.