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.

Trial Capabilities Specialist/Sr Specialist/Expert Specialist

Purpose:

The Trial Capabilities Specialist role provides technical support to the clinical Trial Capabilities team in support of clinical development. The Specialist works as part of the Portfolio Support Centralized team responsible for administrative and technical activities related to clinical trial submissions and investigator sites readiness, maintenance and close out. 

Additional 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 of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Printing and shipping of clinical trial documentation to clinical trial hospital sites and any other printing in Trial Capabilities as required.Organizing and tracking stationary orders for Trial Capabilities.Support Trial Capabilities vendors finance activities as needed including creation of Purchase Orders and vendor’s invoice query resolutions.Responsible for data entry of clinical trial information and documentation into clinical trial submission portals.Support with monitoring of the clinical trial submission portal for notices and alerts and communicating to appropriate personnel.Serve as point of contact for translation requests of clinical trial documentation and provision of translated documents to Trial Capabilities teams.Identify, communicate, and resolve issues.Support with archiving of documents to meet Lilly record retention policies and regulatory requirements.Where applicable, ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Minimum Qualification Requirements:

Two-year degree or 2 years administrative or technical experience.One-year administrative experience or relevant experience preferred.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.Very good attention to details and accuracy.Self-management and organizational skills.Excellent computer skills.

Other Information/Additional Preferences:

Ability to effectively prioritize and complete key tasks and deliverables.Ability to work in global team environment and communicate effectively with both internal business partners of all levels & disciplines as well as external key stakeholders.Full professional proficiency in English is required. Additional language skills are preferred. 

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$16.58 - $39.06

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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