Associate/Sr Associate - Clinical Trials North America Maintenance
Eli Lilly
- Cork
- Permanent
- Full-time
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 YourselfThe North America Maintenance Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to support ongoing activities during site maintenance and close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals for study changes, execution of any amendment to the budget and contract, and activities related to clinical finance and records management. 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.Primary Responsibilities: 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:
- Leverage trial prioritization to manage all site maintenance requests to drive timelines aligned with company priorities
- Manage any site level changes (change of Principal Investigator, Sub-Investigator and/or site location change)
- Facilitate Site Level Informed Consent Form updates resulting from amendment/addenda, Investigator Brochure update, etc.
- Facilitate approval of additional patient-facing materials throughout the trial (site-specific recruitment material, patient-facing retention material, patient reimbursement, etc.)
- Negotiate and execute budget and contract amendment driven by protocol changes
- Support investigator payments to resolve invoice-related queries
- Complete site close-out verification activities
- Maintain an active collaboration with sites during maintenance and close-out
- Communicate Unblinded Treatment Assignments to sites
- Address requests related to the Clinical Study Report
- Ensure TMF Functional Check Placeholders are closed
- Identify, communicate, and resolve issues; collaborate with peers and cross-functional partners, as needed, to ensure effective site management
- 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
- Anticipate and monitor dynamically changing priorities
- 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 activation
- 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
- Organizational skills
- Language Capabilities (all work done in English, another language may be appreciated)