Lilly Jobs

Job Information

Lilly Amendment Team Trial Capabilities Associate in Cork, Ireland

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 35,000 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.

The Clinical Trial Start-up Associate role ensures that patients will have access to our clinical trials with the aim of making life better for our patients. The Associate is accountable for obtaining all approvals (Competent Authority and Ethical Review Board) to run the trial in the EMEA and AMERIT Regions. The Associate will also have responsibility to ensure the investigator sites meet the requirement to enrol the study participants in the clinical trial and support maintenance and closeout activities.

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.

Your 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), 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

  • Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.

  • Create, review and customization of country/site specific Informed Consent Forms (ICFs).

  • 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

  • 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

Education:

  • Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred

Language

  • Fluency in English and (insert Language as required) is essential.

Experience

  • Applied knowledge of project management processes and skills

  • 2-5 years’ experience in clinical development, with some experience in clinical research/ Involvement in cross-functional clinical trials/experience in supporting the operational activities of clinical trials.

  • Appreciation of / experience in compliance-driven environment

  • Effective communication, negotiation, and problem-solving skills and demonstrated ability to meet timelines.

  • Self-management and organizational skills.

  • Knowledge of Good Clinical Practice and understanding of the overall drug development process.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help 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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

DirectEmployers