Consultant- Clinical Operations

Responsibilities

• 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.
• Perform 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 the primary contact and partner for investigator sites (CROs/internal sites), ensuring high-level data integrity.
• Support protocol development, study planning, and final study reports.
• 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.

Requirements

• 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.

Qualifications

• 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.

Benefits

Elanco offers a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose!

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching