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 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials, and more.
Lilly 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.
Job description The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management, and site training.
The Associate will ensure inspection readiness through a complete, accurate, and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
Key Objectives / Deliverables: Clinical Trial Capabilities Responsibilities Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.Identify, communicate, and resolve issues.Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.Leverage previous site/review board engagements to efficiently drive new work.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.Leverage trial prioritization.Anticipate and monitor dynamically changing priorities.Qualification Requirements: Bachelor's degree preferably in a scientific or health-related field, two years clinical research experience or relevant experience preferred.Understanding of the overall clinical development paradigm and the importance of efficient site initiation.Applied knowledge of project management processes and skills.Appreciation of/experience in a compliance-driven environment.Ability to learn and comply with financial and legal guidelines and policies (budget and contract).Effective communication, negotiation, and problem-solving skills.Self-management and organizational skills.Language capabilities in English and Polish are essential.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ****** ) for further assistance. Please note this email address is intended for use only 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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