▷ 15h Left: Snr Associate/Manager

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 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 are looking for people who are determined to make life better for others.

Eli Lilly Cork is a diverse team delivering innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. The Cork campus offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking, along with in-house People Development services and wellbeing initiatives to enhance the career experience.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI) across all dimensions, with pillars EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network, to promote awareness and create an inclusive environment.

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

Purpose

The Trial Capabilities Associate, Complete Trial Package (CTP) Project Manager is accountable to ensure the CTP required for Regulatory and Ethics committee submission includes all regulatory documents required for initial Clinical Trial application as well as any subsequent submissions for all participating countries globally. The associate collaborates with CDDA functions, CMC, and other contributing teams to plan timely delivery of all required documents and tracks delivery to ensure timely submission. Additional local responsibilities may be required for local geography and regional differences. The role supports trials initiated in Phase I-IV across all therapeutic areas.

Primary Responsibilities

- Provide guidance to the study team regarding Lilly required and regulatory required documentation, processes, and other aspects of the complete trial package.
- Partner with Design Hub, Clinical Development, CMC, Trial capabilities in all regions, and associated Third Party Organizations (TPOs) to define, document, and deliver document requirements within agreed timelines to enable on-time delivery of the complete trial package.
- Create, update, and track document requirements and delivery in the regulatory document tracker at the trial level.
- Communicate timelines with appropriate study team members and implement risk mitigation and contingency plan strategies to ensure on-time document delivery.
- Drive timelines-based study priority, ensuring accelerated novel approaches are adopted for Game Changers and Potential Game Changers.
- Escalate document delivery issues, as appropriate.
- Initiate the insurance certificate process for all countries participating in the trial where applicable.
- Ensure all documents required from the global study team for initial country submissions are provided to the affiliates and TPO partners.
- Develop and utilize appropriate document delivery planning and tracking tools, owning communication across the study team, affiliates and TPOs, and holding partners accountable for delivery.
- Populate internal systems to ensure accuracy of trial/site performance.
- Understand, comply with, and promote complete trial package process improvements and technology systems, and identify suggested improvements.
- Provide feedback and shared learning for continuous improvement.
- Anticipate and monitor dynamically changing priorities.

Minimum Qualification Requirements

- Bachelor’s degree preferably in a scientific or health related field.
- Applied knowledge of project management processes and skills.
- Appreciation of / experience in a compliance-driven environment.
- Effective communication, negotiation, and problem-solving skills.
- Self-management and organizational skills.

Additional Preferences

- Two years clinical research experience or relevant experience preferred.
- Excellent communication (written and verbal) skills.
- Strong knowledge of data privacy regulations, intellectual property, and clinical trial regulations.
- Ability to make business-driven decisions.
- General understanding of the overall clinical development paradigm and the importance of efficient site activation.

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. This is for individuals 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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