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 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 are 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 across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials, and more. We offer a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking.
Eli Lilly Cork is committed to diversity, equity, and inclusion (DEI), ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender.
The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems and/or digital health technologies supporting clinical development. In this role, you will define and execute implementation plans to deliver on procedural requirements, strategies, integrations, improvements, and shared learnings. The Associate Director is responsible for collaborating with business partners to enable development, implementation, and support of streamlined, clear, and compliant systems to support clinical development.
Primary Responsibilities:
Clinical Information Systems Expertise
* Understand business strategies, data flow, 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.
* Support internal audits and external inspections.
* Identify key functional capability gaps early to ensure robust processes are in place.
* Introduce efficiencies into the technical landscape.
Project Management
* Define, lead, and execute implementation plans to deliver on procedural requirements, technology strategies, and improvements.
* Coordinate development of Fit For Purpose plan and research proposed technologies.
* Challenge plans/dataflow for infusion of best practices into clinical research.
* Conduct shared learning sessions and be a strong voice at that table.
* Develop critical success factors for pilots/projects and monitor progress.
* Identify, monitor, and communicate global customer needs related to process and/or technology performance.
* Lead organizational change, communication planning, and training initiatives.
* Identify project implementation and system execution risks and raise issues appropriately.
* Lead progress reporting activities and system metrics to leadership and end users.
Partnership
* Partner with process owners, leadership, Quality, and Information Technology to ensure capable, integrated, and efficient system usage.
* Lead assessments and actively drive shared learning across the team.
* Work with vendors to improve customer experience and efficiencies.
Minimum Requirements:
* Bachelor’s degree preferably in science, IT, or health-related field, or equivalent work experience.
* 5 – 8 years experience with at least 3 years in medical, clinical data management, clinical drug development, or clinical information flow.
* Digital/Technical Literacy, Pharma experience, GCP-Clinical Trial Regulations Fluency.
* Excellent oral and written communication skills.
* Strong problem-solving skills; able to anticipate and recognize problems.
* Team Player with demonstrated ability to lead large projects.
* Strong interpersonal skills and flexibility to adjust quickly to changes.
Additional Preferences:
* Experience in clinical development systems and evolving technologies.
* Knowledge in project management and organizational change.
* Good interpersonal and leadership skills.
* Flexibility in approach; able to adjust to unexpected business opportunities.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance.
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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