Associate - Exploratory Medicine and Pharmacology - Clinical Delivery Trial Associate

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 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork 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.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all 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, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

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 EMP (Exploratory Medicine &  Pharmacology) 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 Clinical Delivery Trial Associate will ensure inspection  readiness through a complete, accurate and readily available Trial Master File. Knowledge of ICH (International Conference on  Harmonization) (International Conference on Harmonisation) and quality guidelines is needed for the successful delivery of the portfolio and clinical trials. The Associate will seek knowledge from internal and external sources and use this information to 
build continuous improvement opportunities. 

Primary Responsibilities:

This job description is intended to provide a general overview of the various job requirements. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with supervision regarding actual job responsibilities and any related duties that may be required for the position. 

1. 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 (Good Clinical Practice) 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
• Identify, communicate, and resolve issues.
• Understand FRAP (Financial Responsibility and Authorization Policy) and consult with teams regarding FRAP
• 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.
• 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

• Clinical Development Studies.

• Compliance.

• 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 (Good Clinical Practice) or local
• 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
• Identify, communicate, and resolve issues.
• Understand FRAP (Financial Responsibility and Authorization Policy) and consult with teams regarding FRAP
• 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.
• 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

2. Systems And Processes Support:

• critical business systems, producing reports as needed. 
• Collaborate in the development and maintenance of business processes for assigned TPOs (Third Party Organisation)
• Help maintain study archetype templates
• Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical
• Understanding of the overall clinical development paradigm and the importance of efficient site activation and
• Strong self-management, analytical and organizational skills.
• Demonstrated problem-solving abilities.

• (E.G., Operations Guides).

• Collaborate in the development and maintenance of business processes for assigned TPOs (Third Party Organisation)
• Help maintain study archetype templates
• Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical
• Understanding of the overall clinical development paradigm and the importance of efficient site activation and
• Strong self-management, analytical and organizational skills.
• Demonstrated problem-solving abilities.

Minimum Qualification Requirements:

• Industry Experience).

• Maintenance

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 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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