Clinical Process Management Consultant
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 39,000 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 people around the world
The Clinical Information and Process Automation (CIPA) organization is comprised of centralized and dedicated Process Owners of clinical development processes and System Owners for clinical development systems. We are accountable for the design, sustainability, as well as efficiency and effectiveness of end-to-end global clinical development processes. We are also responsible for the development, implementation, and maintenance of clinical information management and process automation strategies and plans. The processes and systems owned within CIPA are executed by anyone across the company who has a role in the design, planning, execution, and management of clinical trials.
Do you have a passion for continuous improvement? Are you good at identifying opportunities to increase process efficiency and effectiveness? Have you defined and executed implementation plans to deliver a stream-lined process to an organization? If so, we have the role for you.
As the Consultant - Process Owner you will be responsible to sustain and continuously improve the efficiency and effectiveness of assigned global clinical trial process(es). You will collaborate with other Process Owners, Clinical Development, CIPA leadership, Site Engagement, Clinical and Laboratory Data Sciences, Statistical Sciences, Quality and CIPA System owners. You will apply technical and process management expertise to effectively manage your assigned process(es), and to ensure they are compliant, fit-for-purpose, and efficient. You will also partner with our vendor companies who may be responsible for delivering these capabilities/systems.
This role partners with the Advisor Process Owner to ensure processes integrate with the end-to-end clinical development operating system in order to deliver efficiencies in clinical research. You will do this by leading cross functional project teams through development or refinement of process maps, Quality system documents (e.g. procedures and required tools), and training content for the process. You will establish clear understanding of assigned clinical process(es) including clarity of process inputs, outputs and dependencies (e.g., connected processes, information flow implications), and functional role accountable for critical process steps. To achieve these goals you will:
- Partner with Advisor Process Owner, line management and functional subject matter experts (SMEs) to ensure process execution expectations are clear, collect process performance feedback, and make sure the process runs smoothly and efficiently.
- Understand the external environment and changes that may affect your assigned process(es) and lead the development of action plans, as needed.
- Influence key stakeholders concerning the design, timing and implementation of process changes to ensure changes are well integrated into the overall operating system and uptake by the business is optimized.
- Engage in coaching and training others, as needed, to ensure the effective implementation and execution of assigned processes.
- Bachelor's Degree, preferably in a science- or health-related field.
- A minimum of five years' experience in drug development
- 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
- Demonstrated influence with peers and management
- Demonstrated ability to lead change for focus area(s)
- Proven ability to synthesize information from multiple sources and make risk-based decisions
- Understands quality systems and process management
- Experience with site monitoring and/or issue management processes
- Six Sigma Black Belt or Green Belt experience
- Demonstrated ability to collaborate across boundaries and achieve results with internal and external partners
- Ability to work in a dynamic environment and deal with complexity
- Located in Indianapolis
- Some travel may be required
- Lilly is an EEO/Affirmative Action Employer and 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