Associate/Sr Associate - Trial Capabilities, Budgets & Contracts
Eli Lilly
- Cork
- Permanent
- Full-time
work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.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!Purpose:The Trial Capabilities Associate/Sr Associate, Budgets & Contracts provides clinical trial capabilities in support of clinical development. The Associate, Budgets & Contracts is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials from budgets and contracts perspective and support ongoing budgets and contracts activities during site maintenance and close-out. The Associate, Budgets & Contracts is responsible for execution of the budget and contract, and activities related to clinical finance and records management. The Associate, Budgets & Contracts will ensure inspection readiness through contribution to 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.This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Clinical Trial Responsibilities
- Initiate investigator site activities, including communicate and negotiate budgets and contracts with site personnel, service providers and internal teams, negotiate and obtain fully-executed contract, and effectively drive timelines aligned with company priorities
- Responsible for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility
- Responsible for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites regarding budgets and contracts activities during maintenance and close-out
- Identify, communicate, and resolve issues related to budgets and contracts
- Ensure country specific regulatory and data privacy requirements are incorporated into budget and contract 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 relevant 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
- Collect and administer financial data from contracting partners and vendors
- Ensure finance specific requirements are administered in budget and contract documents
- Ensure internal financial requirements are communicated to contracting partners and vendors
- Ensure contracting partner and vendor financial requirements are communicated to internally
- Support contracting partners, vendors and internal stakeholders during the payment process
- Identify, communicate, and resolve issues related to payments
- Bachelor’s degree preferably in a scientific, health related, engineering, economics or project management field, two years clinical research experience (CRO, sponsor or healthcare service provider) or relevant budget and contract negotiation experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills preferred
- 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 (English and another European language)