Overview
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. Lilly is committed to diversity, equity and inclusion (DEI) with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.
Purpose
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent, transparent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
Role
The Clinical Trial Registry and Transparency (CTRT) Specialist is responsible for collecting and preparing redacted documents/packages required to be submitted to EU Clinical Trial Regulation (EU CTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), National Institutes of Health (NIH), and other global disclosure and transparency regulations.
Primary Responsibilities
* Develop knowledge and understanding of the redaction process.
* Collaborate cross-functionally with applicable team members and departments (e.g., Statistics, medical, clinical trial management, Manufacturing CT Material Supply) to obtain and review documents needed for submission.
* Collect documents that will be submitted to EU CTR, EMA Policy 0070, Health Canada PRCI, NIH, and other global regulations by searching Veeva Vault and other document repositories.
* Upload documents in Veeva Vault in preparation for CCI and PI review and assign tasks.
* Redact documents for personal information and company confidential information based on inputs.
* Manage EMA Policy 0070, Health Canada PRCI and EU CTR workflows in Veeva Vault.
* Manage redaction trackers and partner with Trial Capabilities, Design Hub to obtain up-to-date study information for submission to EU CTIS.
* Identify opportunities for redaction process improvement.
Other Transparency Requirements As Needed
* Identify, track and report on clinical trials required for disclosure.
* Quality check redaction work of CTRT or vendor staff.
* Manage access rights to applicable systems as needed.
* Create, maintain, and utilize technology to manage CTRT tracking and reporting processes.
* Support CTRT systems, processes, and workflows.
* Communicate deliverables, timelines, and deadlines for CTRT requirements to responsible functions.
* Escalate issues in a timely and appropriate manner.
* Share key learnings.
Minimum Qualifications
* Certificate/ Diploma equivalent required.
* Strong interpersonal skills and flexibility across environments and time zones.
* Demonstrated high-level end-user computer skills (MS Office: Word, Excel, PowerPoint, etc.).
* Strong written and oral communication skills in English.
Information/Additional Preferences
* Bachelor’s degree preferred.
* Background in clinical Data Disclosure & Transparency and Redaction.
* Ability to be flexible in varying environments and with multiple customer groups.
* Ability to work well across cultures and time zones.
* Highly organized with ability to manage multiple projects concurrently, deliver high quality results.
* Attention to detail and commitment to excellence.
* Ability to work under pressure, maintain a positive attitude.
* Ability to work independently and collaboratively in a team.
* Project management experience.
* Willingness to travel as required.
Lilly is dedicated to helping individuals with disabilities engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form. 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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