Consultant- Clinical Operations
About The Position
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Senior Clinical Research Associate (CRA) – Animal Health As a Senior Clinical Research Associate (CRA) – Animal Health, you will be part of our Global Clinical Development Sciences team, responsible for leading and executing clinical monitoring for critical laboratory and field studies. In this role, you will be responsible for implementing robust monitoring plans, partnering with project teams and Contract Research Organizations (CROs) to ensure study results are of the highest quality and support global regulatory approvals for new Farm Animal and Pet Health products.
Requirements
- 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.
- Proven experience monitoring single-site or multi-site clinical field safety and effectiveness studies.
- 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.
Nice To Haves
- 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.
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.
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
