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Sr. Specialist/Expert Specialist

4 weeks ago

Cork, Cork, Ireland Eli Lilly and Company Full time
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. In-house 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 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.

Primary Responsibilities:

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

Minimum Qualification Requirements:

1. Two-year degree or 2 years administrative or technical experience.
2. One-year administrative experience or relevant experience preferred.
3. Appreciation of / experience in compliance-driven environment.
4. Ability to learn and comply with regulatory requirements and internal policies.
5. Effective communication, teamwork and problem-solving skills.
6. Very good attention to details and accuracy.
7. Self-management and organizational skills.
8. Excellent computer skills.

Other Information/Additional Preferences:

1. Ability to effectively prioritize and complete key tasks and deliverables.
2. 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.
3. Full professional proficiency in English is required. Additional language skills are preferred.

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.

#WeAreLilly

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.

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