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.

Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Lilly offers a premium workspace across our campus in Little Island,  complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.  Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Job Description:

The Trial Capabilities Specialist role provides technical support to the clinical trial capabilities team in support of clinical development.  The specialist is responsible for activities related to investigator sites readiness, maintenance and close out.  The specialist will ensure inspection readiness through a complete, accurate and readily available Trial Master File.  Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.  

The Trial Capabilities Specialist role will join the Portfolio Support Centralized team which provides technical support to the clinical trial capabilities team. The Portfolio Support Centralized team consists of the CTIS Central Team and EMEA Central Amendments Team.

General Responsibilities:

Provide support with print & ship activities, stationary orders.

Process patient reimbursement vouchers and arrangement of shipment to sites.

Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.

Ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Identify, communicate, and resolve issues.

Initiate investigator site activities, including collection and submission of regulatory documents.

Track and ensure site compliance to effectively drive timelines aligned with company priorities

Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Ensure appropriate archiving of documents to meet Lilly record retention policies and regulatory requirements.

CTIS Central Team Primary Responsibilities:

Responsible for data entry of clinical trial information and documentation into CTIS (Clinical Trial Information System), a clinical trial submission portal.

Monitoring of the CTIS portal for notices and alerts and communicating to the appropriate personnel.

EMEA Central Amendments Team Primary Responsibilities:

Serve as point of contact between Trial Capabilities and other functions for amendments.

Track amendments, compile core submission package and communicate amendments to the appropriate country teams.

Qualification Requirements:

A degree or equivalent 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

Ability to learn and comply with regulatory requirements and internal policies.

Effective communication, team work and problem solving skills

Very good attention to details and accuracy

Self-management and organizational skills

Excellent computer skills

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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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