Associate Director – Clinical Trial Foundations

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.

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 focus of this role will be to support data collection systems, primarily focused on EDC and data aggregation systems. 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.

• 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
• 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
• Collaborate with stakeholders for new system implementation

• Bachelor’s degree in a scientific or health related field
• Minimum 3 years’ experience in medical, quality, clinical drug development, or clinical information flow
• Deep knowledge of data collection and aggregation systems (prefer experience with Veeva EDC and CDB)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

• Experience in clinical development systems as well as current and evolving technologies to support clinical development
• Deep knowledge of cyber security, privacy, and or information security
• Strong understanding of labs, including data flow and 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
• F…