The Clinical 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.
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
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 500 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! The new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings.
Our benefits package includes healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, educational assistance, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.
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.
“We see Cork as an integral part of our productivity agenda. If you are excited by new opportunity and new scope, you are working at the right place.” – Dave Ricks, CEO Lilly
We are excited now to add another capability to the existing GBS team. The Clinical Trial Capabilities Team will focus on clinical research and, in particular, clinical study start-up activities across the EU and other regions, e.g. Middle East, Africa and Russia. The Clinical Trial Capabilities Centre will allow us to provide an unparalleled clinical trial experience for investigators and patients and ultimately achieve Lilly’s goal of speeding innovation and bringing our medicines to patients who need them.
If you want to contribute to this goal for our patients please apply to one of our new roles today. All current open positions are permanent roles.
- 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 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 following: English, German, French, Spanish, Italian, Polish, Swedish, Danish, Finnish, Czech, Hungarian, Romanian, Dutch, Flemish, Swiss German, Austrian German, Slovakian, Arabic, Hebrew, Russian, Ukrainian, and Turkish