Job Description

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 35,000 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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

The Trial Capabilities Specialist role provides technical support to clinical trial capabilities team in support of clinical development. The Specialist is responsible for activities related to study start-up (SSU) and investigator site\'s readiness for patient enrollment, maintenance and close out. The Specialist will ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Responsibilities:

Track site compliance to required training to effectively drive timelines aligned with company priorities.

Manage/coordinate clinical trial system account request for investigator sites, as applicable.

Identify, communicate, and resolve issues.

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.

Support inspection readiness through a complete, accurate and readily available Trial Master File including performing quality review periodically on documents related to Trial Capabilities.

Anticipate and monitor dynamically changing priorities

Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)

Minimum Qualification Requirements

• A diploma/degree or equivalent, preferably in a scientific or health related field
• Clinical research experience or relevant experience preferred
• Applied knowledge of project management processes and skills
• Appreciation of/experience in compliance-driven environment
• Ability to learn and comply with regulatory requirements, and internal policies.
• Effective communication, teamwork and problem-solving skills; good attention to details and accuracy; self-management and organizational skills
• Excellent computer skills
• Language capabilities \xe2\x80\x93 English (read, write, conversation)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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