About The Position
As a Senior Clinical Research Associate (CRA) – Animal Health, you will be a key member of our Global Clinical Development Sciences team, dedicated to advancing Elanco’s portfolio of Farm Animal and Pet Health products. In this role, you will be responsible for guiding and executing crucial clinical monitoring for laboratory and field studies, partnering with project teams and CROs to ensure our study results meet global regulatory standards and drive successful product registrations.
Requirements
- A Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR a 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 studies for safety and effectiveness.
- Demonstrated interpersonal skills with the ability to work within and across interdisciplinary teams, combined with a strong knowledge of animal health concepts and global clinical trial regulations.
Nice To Haves
- Direct experience with regulatory authority submissions and a deep understanding of the data requirements for successful filings.
- Experience acting as a lead monitor or mentor for other Clinical Research Associates on clinical projects.
- Advanced proficiency in clinical trial management systems, such as Veeva Vault, and other collaborative tools.
- Specialized experience in either Farm Animal or Pet Health clinical studies.
- Proven ability to anticipate issues and proactively ensure innovative solutions in a fast-paced, matrixed environment.
Responsibilities
- Oversee the monitoring and execution of farm and companion animal clinical trials, ensuring all activities comply with global regulatory standards (GCP/VICH) and internal policies.
- Author and execute comprehensive monitoring plans; conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study requirements.
- Perform thorough data review (QC) and query resolution to ensure the highest level of data integrity and quality across all assigned studies and projects.
- Serve as the primary contact for investigator sites and third-party organizations (CROs), overseeing study site documentation, investigational material shipments, and drug accountability.
- Collaborate with cross-functional partners, including Regulatory Affairs and Data Management, to support protocol development, study planning, and the development of final study reports and submission files.
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
