Senior Associate

Eli Lilly Cork is made up of a talented diverse team of over 1,600 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.

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.

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, Age & Culture, LGBTQ+ 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!

Job Description

The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Clinical Trial Start Up Associate is accountable to ensure the investigator sites meet requirements to enroll 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 / Senior 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.

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, five (5) years clinical research experience or relevant experience preferred

Understanding of the overall clinical development paradigm and the importance of efficient site initiatio

Language capabilities: Native Turkish speaker and fluency in English is essential for this role

Applied knowledge of project management processes and skills

Appreciation of / experience in 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

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 ( Lilly_Recruiting_Compliance@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.

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