Associate - Exploratory Medicine And Pharmacology - Clinical Delivery Trial Associate

Overview

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 put people first and seek teammates who are determined to make life better for people globally.

Eli Lilly Cork comprises a diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions across Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

We offer a premium workspace on our campus in Little Island 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 wellbeing initiatives are part of the holistic benefits that support the career experience for our colleagues.

Lilly Cork is committed to diversity, equity and inclusion (DEI).

We support all dimensions of inclusion across ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender with four pillars : ENAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network.

EnAble partners with the Access Lilly initiative to promote accessibility and an inclusive environment for all.

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

Purpose :

The purpose of the Clinical Delivery Trial Associate role is to support Exploratory Medicine & Pharmacology (EMP) and to serve as a technical and process expert in exploratory and biopharmaceutical clinical development and document management for clinical trials and business processes.

The role ensures inspection readiness through a complete, accurate, and readily available Trial Master File.

Knowledge of ICH guidelines and quality standards is needed for successful portfolio and clinical trial delivery.

The Associate will seek knowledge from internal and external sources to build continuous improvement opportunities.

Primary Responsibilities :

This job description provides a general overview of the responsibilities, which may evolve over time.

Consult with supervision regarding actual duties.

Clinical Trial Support

Establish, maintain and archive compound-related files and trial-related files as required per procedures.

Partner closely with Clinical Trial Project Manager and Program Lead to deliver clinical trials.

Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or local regulations for Start-up, Maintenance and Close-out of the study.

Assist in the planning, forecasting, and tracking of trial budgets, Purchase Orders, and invoices.

Assist in performing assessments of potential vendors and investigator sites for exploratory and biopharmaceutics clinical development studies.

Identify, communicate, and resolve issues.

Understand FRAP (Financial Responsibility and Authorization Policy) and consult with teams regarding FRAP compliance.

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

Understand and comply with procurements, legal and financial requirements, and procedures.

Populate Trial Master Files and libraries for future reference.

Provide feedback and shared learning for continuous improvement.

Anticipate and monitor dynamically changing priorities.

Systems and Processes Support

Create and maintain collaboration sites at process, compound, or trial levels for the organisation.

Proactively establish and ensure accuracy and completeness of information in VEEVA (Veeva), Planisware and other critical business systems, producing reports as needed.

Collaborate in the development and maintenance of business processes for assigned Third Party Organisations (e.g., operations guides).

Help maintain study archetype templates.

Minimum Qualification Requirements :

Bachelor's Degree in a scientific or health-related field; or equivalent qualifications / experience (3 years pharmaceutical industry experience).

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

Strong self-management, analytical and organizational skills.

Demonstrated problem-solving abilities.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities.

If you require accommodation to submit a resume for a position at Lilly, please visit .

This is for accommodation requests as part of the application process.

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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