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 **** 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
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 projects and initiatives.
Define, manage, and execute TMF implementation plans for the trial from start-up to close-out.
Communicate global internal/external requirements as it relates to the TMF during collaborative functional meetings.
Collaborate and influence functional representatives and record owners to ensure TMF remains complete, current and correct.
Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Clinical Trial Essential Document Responsibilities
Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial specific TMF.
Evaluate the TMF records prior to finalization, as appropriate.
Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance and close-out of the trial.
Identify, communicate, and resolve issues.
Ensure appropriate functional check oversight activities occur for all functional areas.
Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements.
Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)
Trial Management Systems Operations
Maintain and grow expertise in clinical information systems & business strategies, processes and technology as it relates to clinical development.
Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with Veeva Vault Clinical Platform and other applicable systems.
Support internal audits and external inspections.
Define, lead, and execute implementation plans to deliver on technology strategies and improvements.
Develop & monitor critical success factors for pilots/projects and report progress to ensure clear criteria exists to enable decision making.
Identify, monitor, and communicate global customer (internal and external) needs/ requirements as related to process and/or technology performance and improvements.
Lead organizational change, communication planning, and training initiatives related to the adoption and implementation of VC functions.
Provide guidance and consulting into forecasting expenses.
Identify project implementation and system execution risks and raise issues appropriately.
Lead and deliver progress reporting activities and system metrics to leadership, process owners and end users.
Partner with process owners, leadership, Quality and to ensure capable, integrated and efficient system usage across the portfolio.
Actively participate in shared learning across the team.
Work with vendors to improve customer experience and efficiencies.
Minimum Qualification Requirements
2-4 years' experience with clinical development processes.
Bachelor's degree preferably in science, IT or health related field, or equivalent work experience preferred.
Experience in medical, quality, clinical drug development, or clinical information flow, preferred
Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership.
Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team.
Excellent self-management and organizational skills; able to manage workload, set personal priorities and adjust as needed.
Strong interpersonal skills.
Flexibility to adjust quickly and effectively to frequent change and altered priorities.
Other Information/Additional Preferences
1-2 years TMF experience a plus.
Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.
Advanced degree in relevant field.
Experience in clinical development data systems as well as current and evolving technologies to support clinical development.
Knowledge and/or experience in project management and organizational change with internal and external parties including vendors, industry experts and related organizations.
Strong business insight.
Demonstrated strength in logical thought, problem solving ability and critical thinking.
Ability to communicate and influence across functional boundaries.
Flexibility in approach and/or high learning agility.
Knowledge of regulatory and quality requirements governing clinical development.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance.
Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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