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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,400 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.
Lilly 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.
The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. 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. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly's capabilities to support business and customer-focused, efficient clinical development. This role will specifically be focused in the eSource technologies space, including, but not limited to the future state strategy, innovation, and development of direct data capture capabilities, ingesting electronic medical records, and other technologies supporting the digitization of patient source data from investigator sites. Primary Responsibilities:Clinical Information Systems Expertise Understand 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 these systems.
Support internal audits and external inspections.
Ensure data from different sources are consistent and easily consumable.
Map collected data into predictable source/raw data - Accountable for specifications for raw data at study level ensuring consistent, standardized and easily consumable data.
Articulate programming needs to complete normalization of data from various sources into clinical data warehouse.
Understand inconsistencies in data and provide feedback to standards team.
Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays.
Project Management Define, lead and execute implementation plans to deliver on technology strategies and improvements.
Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making.
Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements.
Lead organizational change, communication planning and training initiatives.
Provide guidance and consulting into forecasting expenses.
Identify project implementation and system execution risks and raise issues appropriately.
Lead progress reporting activities and system metrics to leadership, process owners and end users.
Partnership Partner with process owners, leadership, Quality and Information Technology 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 Requirements:Bachelor's degree preferably in science, IT or health related field, or equivalent work experience preferred.
5 – 8 years experience with at least 3 years in medical, clinical data management, clinical drug development, or clinical information flow.
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 recognise problems, diagnose root causes and take corrective action to prevent recurrence within the team.
Excellent self-management and organisational 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.
Additional Preferences:Experience in clinical development systems as well as current and evolving technologies to support clinical development and clinical data management.
Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations.
Good interpersonal and leadership skills.
Excellent oral and written communication skills.
Strong business insight.
Demonstrated strength in logical thought, problem solving ability and critical thinking.
Ability to communicate and influence across functional boundaries.
Ability and experience in positively handling and resolving conflict.
Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change.
Knowledge of regulatory and quality requirements governing clinical development.
10% or less travel.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources (******) for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. 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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