Associate/Sr. Associate Clinical Trial Start Up, Germany

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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. Lilly Cork 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. Inhouse People Development services, Educational Assistance, and our Live Your BEST Life wellbeing initiatives are part of the holistic benefits that enhance the career experience.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI) with pillars EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble partners with the Access Lilly initiative to promote an accessible and inclusive environment for all. Come join our team - Be Creative, Be an Innovator, and Be Yourself

The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure investigator sites meet requirements to enroll study participants and to support ongoing activities during site maintenance and closeout. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, activities related to clinical finance, records management and site training. The Associate will ensure inspection readiness through a complete, accurate Trial Master File. Additional local responsibilities may be required for the local geography and/or to cover regional differences.

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 where applicable; track and ensure site compliance to required training; drive timelines aligned with company priorities.
• Communicate directly with sites to enable start-up and maintain 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 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 and anticipate dynamically changing priorities.

Qualification Requirements

• Bachelor's degree preferably in a scientific or health-related field or 5+ years clinical research/clinical operations experience or relevant experience.
• Understanding of the overall clinical development paradigm and the importance of efficient site initiation.
• Native German speaker with fluency in English preferred.
• 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.

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 for further assistance. 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.

Additional information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Other
• Industries: Pharmaceutical Manufacturing

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