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.

Primary Responsibilities For System’s Function

• The role requires candidates to work on various clinical systems used across CDDA (Clinical Design, Delivery, and Analytics) and other functions in Clinical trial Foundation (CTF)
• Manage user access to relevant systems ensuring that users have met the access requirements
• Use Service now to receive and document issues (INCs) and requests and actions taken.
• Understand and respond to customer feedback on systems.
• Develop and maintain metrics as needed.
• Provide as needed support for the timely installation of new releases and patches by providing technical expertise, associated training, and business process development.
• Resolve system issues quickly to ensure continued access; apply root cause analysis as needed.

Primary Responsibilities Of Clinical Trial Operations

• Knowledge of Good Clinical Practice (GCP), Good Documentation practice (GDP), Understanding of regulatory framework and other relevant regulations and guidelines.
• Understand drug discovery and development, clinical trial phases, study design, & protocols
• Understand & Support in clinical trial operations and process management.
• Conduct quality checks to ensure data integrity and support issue resolution.
• Provide administrative support to the clinical operations team and develop and maintain metrics as needed.
• Collate output from multiple data sources and conduct qualitative review.
• Assist with various tasks and projects to support the cross-functional team as needed.
• Participate in training, stay updated on industry trends, troubleshoot technical issues, and provide user support.

Skillsets Required/ Additional Preferences

• Effective teamwork skills; able to adapt to diverse interpersonal styles and leadership skills
• Exceptional verbal, written communication, and presentation skills.
• Demonstrated strength in logical thought, problem solving ability and critical thinking.
• Ability and experience in building consensus and resolving conflict to drive progress.
• Strong attention to detail & Ability to prioritize projects. Flexibility in approach and/or high learning agility
• High proficiency in Microsoft Office and Adobe Acrobat applications, with the ability to learn and use new software/technology.
• Ability to manage multiple tasks simultaneously.
• Excellent analytical skills

Takeaways From The Role For The Candidate

• Subject Matter Expert knowledge within assigned Clinical Trial Operations (eTMF, Monitoring Oversight) and System’s Function
• Learn planning and execution of product lifecycle using available platforms (document management system, MS Teams, SharePoint)
• Stakeholder management and work prioritization
• Leverage technical and regulatory expertise for better results in day-to-day deliverables.