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.
Purpose:
Clinical Trial Foundations as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. The Associate, Sr. Associate, Manager, Clinical Trial Foundations will serve as the business subject matter expert for the systems within the clinical development. These roles will be responsible for executing business projects and maintaining capabilities on system processes, integrations and improvements. These roles are responsible for collaborating with other functional areas within Clinical Design, Delivery & Analytics (CDDA) and Tech@Lilly to execute implementation. These roles will also partner with our vendors who are delivering these capabilities.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Clinical Systems and Capability Expertise
- Manage clinical technology projects that span across multiple functions, vendors, and external organizations pertinent to the area of focus
- Ensure process and/or technology interfaces are optimized across all affected areas
- Provide business case analysis as needed
- Define, measure and achieve proficiency with new tools/technology and processes applicable to focus area.
- Produces and maintains project documentation as required, including that of appropriate quality systems
- Support internal audits and external inspections
- Provide knowledge of technologies and how they can enable processes across clinical development
- Use standardized processes for requirements definition, analysis, design, construct, and test activities
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Project Management
- Resolve operational issues that arise and apply shared learnings across functions and to external partners
- Create best practices to be shared cross functionally
- Perform root cause and impact analyses and apply knowledge to current and future projects with consistency and conformance to Standard Operating Procedures for architecture, data, integrations, and processes
- Partner with various business and therapeutic areas as appropriate to deliver the portfolio
- Develop, track and maintain metrics for area of focus
- Partner with LRL Financial and Procurement to manage budgets, invoice processing, work orders and contracts related to projects
- Coordinate system testing
- Create training and job aides for system releases
Partnership
- Proactively identify, anticipates, monitor and communicates global customer needs and requirements that are related to process and/or technology
- Partner and/or strengthen relationships between key providers or customers within clinical development and IT
- Partner with vendors to facilitate a good customer experience
- Actively participate in shared learnings across the team
Minimum Qualification Requirements:
- Bachelor’s degree OR 3 yrs experience in medical, quality, clinical drug development, Or clinical information flow with expertise in related processes and evolving technologies as in CDDA, IDS, and/or Quality.
- Demonstrated initiative to build relationships, learn new business processes and identify opportunities
- Demonstrated ability to proactively identify issues and either resolve or escalate to the appropriate level for resolution
- Strong problem-solving skills
- Process improvement skills
- Organization skills
- Self-management
- Curiosity about business and IT processes
- Demonstrated ability to evaluate, facilitate, and drive towards risk-based decision making
Other Information/Additional Preferences:
- Excellent oral and written communication skills
- Project management skills
- Technical knowledge to develop requirements and/or study project deliverables (i.e. SAS, .xml)
- Vendor management/oversight skills
- Technical/System experience
- Clinical research experience/knowledge
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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