The eCOA Operations Associate provides expertise in planning and implementation of electronic modalities in clinical trials within the Clinical Labs and Data Sciences organization (CLDS). The electronic Clinical Outcome Assessment (eCOA) Associate will be responsible for providing guidance concerning technical and process support to the study teams for the following topics: 1) Electronic platform development/execution of instruments intended for data collection (COAs), 2) Copyright, translations, and linguistic validations processes within an eCOA trial, 3) eCOA build processes and project management, 4) Regulatory requirements for eCOA submissions, and 5) Other eCOA related topics. The eCOA Associate will partner with Data Management personnel, the Site Activation Management Group, the Clinical Trial Project Management (CTPM) organization, Health Outcomes, Medical staff and other functions to assess risks and implement contingencies to meet study milestones.
Utilize issue/risk management techniques and strong communication skills to work through vendor, development/implementation and study team issues
Lead and influence the study team through an efficient build process
Gather and provide feedback to strengthen and enhance processes
Recognize big picture, future state connected care, emerging capabilities
Utilization of strong understanding of clinical drug development to enhance study team, site and patient experiences with eCOA
Contribute to project plan for the eCOA cycle partnering with the copyright /translations and COA vendors as well as study team needs
Contribute to vendor oversight process
Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to CLDS deliverables
Provide metrics as requested
Ensure customers understand CLDS roles and responsibilities
Work to improve existing processes and to implement new processes in an efficient manner, including cross-functional process improvement initiatives
Internal Number: 50357
About Eli Lilly & Company
Company Overview 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 worldwide 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.