Job Description
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. As part of our team, you will be responsible for driving clinical development through innovative solutions.
We are committed to diversity, equity and inclusion, ensuring an inclusive environment for all employees regardless of ethnicity, nationality, cultural background, generation, sexuality, visible and invisible disabilities or gender.
Role Summary
The Associate Director, Clinical Trial Foundations (CTF), serves as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on system strategies, integrations and improvements.
Main 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.
* 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.
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 recognize 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.
Prefereable Qualifications
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.