Lilly Associate / Sr. Associate - Clinical Trial Start Up, Turkish 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.
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals. Today more than 900 are based at our Global Business Solutions centre in Little Island, Cork. There we boast a vibrant workforce made up of over 35 nationalities, speaking over 27 languages.
Established in 2010 to gain efficiencies in Finance GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions.
This, along with the current physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story!
At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations.
Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.
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 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.
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
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 initiation
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
Language capabilities in the followings (English, Turkish)
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