Consultant- Clinical Operations

• Education: Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR Master’s degree in a science or health-related field with 3+ years of applicable experience.
• Experience: Proven experience monitoring single-site or multi-site clinical field safety and effectiveness studies.
• Skills: Strong knowledge of animal health concepts and global clinical trial regulations (GCP/VICH); Advanced proficiency in clinical data management systems (e.g., EDC, Veeva) and MS Office 365; Demonstrated leadership skills with the ability to communicate clinical data clearly to diverse stakeholders.

• Experience with compiling clinical trial data for regulatory authority submissions (e.g., FDA/USDA dossiers).
• Experience serving as a lead monitor for specific clinical projects, coordinating the activities of other monitors.
• Demonstrated ability to mentor, coach, and train other clinical monitoring personnel.

• →Lead the monitoring and execution of farm and companion animal clinical trials, providing oversight to ensure all activities remain compliant with global regulatory standards (GCP/VICH).
• →Author and execute comprehensive monitoring plans, overseeing site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols.
• →Serve as the primary contact and partner for investigator sites (CROs/internal sites), performing thorough data review (QC) and query resolution to ensure the highest level of data integrity.
• →Collaborate with cross-functional R&D partners, including Clinical Development, Data Management, and Regulatory Affairs, to support protocol development, study planning, and final study reports.
• →Serve as a primary mentor and coach for Monitoring Team colleagues, driving innovation in monitoring processes and supporting the training of new personnel.
   

• Travel: Up to 50% travel (U.S. and/or International) is required.
• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!