Associate, Sr Associate, Manager - TMF Project Management & Trial Management Systems Operations

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 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 Eli Lilly Cork, 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 45,000 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 patients around the world. 

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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! 

Clinical Trial Foundations as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. The Associate, Sr Associate, Manager - TMF Project Management & Trial management systems operations team member serves in a key role for the execution of TMF Operations processes and administration, while additionally serving as a leader for systems supporting clinical data system development. The TMF Project Management & Trial management systems operations role will execute implementation plans to deliver on the system strategies, integrations, and improvements for site-facing clinical data management systems, and at times will ensure audit readiness and may take part in related regulatory body audits/inspections. Additionally, the role will be responsible for providing process support for TMF creation, maintenance, closure and archival as well as supporting issue resolution with the TMF activities. The TMF Project Management & Trial management systems operations team member will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate and readily available Trial Master File. Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.   

Primary Responsibilities:

1. TMF Expertise & Project Management

• Serve as TMF subject matter expert.
• Partner with internal colleagues to develop and execute metrics to demonstrate control of the TMF process.
• Support internal audits and external inspections, as appropriate (e.g. a table of contents based on the trial-specific TMF Expected Document Lists (EDLs).
• Assists TMF Process Specialist with providing process and planning support to study teams with TMF related remediation and process execution as needed.
• Handles eTMF process related questions and answers.
• Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
• Provide support to ongoing and ad-hoc TMF p