Advisor R&D
Listed on 2026-08-25
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Research/Development
Regulatory Compliance Specialist, Clinical Research
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:
Clinical Trial Manager, Veterinary Medicine
This position will function in the efficient and effective management and execution of clinical studies. The individual will be responsible for continuing to grow and develop capabilities in clinical trial implementation. The incumbent will coordinate, oversee, and monitor clinical studies needed for the registration of global products for Elanco. The individual will maintain an excellent working knowledge of government regulations and policies pertaining to clinical trials, VICH-GCP guidelines, company Standard Operating Procedures (SOPs), and assigned study protocols.
The position will interact with US research scientists and the global research and development teams to gain regulatory approval of these products.
- Plan, manage, and oversee all phases of veterinary clinical trials, including study initiation, site recruitment and training, monitoring, execution, close-out, and compliance with study protocols and SOPs.
- Support high-quality study delivery through protocol and final report review, data capture design, QA/audit responses, risk management, and continuous improvement of trial conduct and data quality.
- Partner cross-functionally with R&D, commercial teams, external partners, and clinical sites to ensure alignment, timelines, quality, and successful study execution.
- Support regulatory and operational activities, including FDA/USDA inspections, communication with regulators, budgeting, contracting, invoicing, forecasting, and vendor selection and oversight.
- Provide leadership and mentorship to study monitors and administrators while contributing to a high-performing, innovative team culture aligned with Elanco values.
- Education:
Bachelor's degree in a science or health related field and 5+ years' experience in veterinary clinical trial management and execution of clinical studies
- Strong background in monitoring of veterinary clinical studies.
- Working knowledge of computer applications including electronic data capture system(s), MS Word, Outlook, Teams, Excel, PowerPoint, Adobe, and SMF applications
Candidates must have direct experience managing and executing veterinary clinical trials. Experience limited to human clinical trials, general clinical operations, or adjacent regulatory/project management work will not meet this requirement.
Top 2 skills- Previous trial management experience in veterinary medicine.
- Proven ability to manage cross-functional teams and collaborate with internal and external stakeholders, including regulatory bodies (FDA/USDA).
- Has experience supporting FDA and USDA inspections and audits, ensuring trial compliance with GCP and regulatory requirements.
- Has led cross-functional collaborations with R&D, commercial teams, and external partners to drive end-to-end clinical trial execution, including protocol development, budgeting, vendor oversight, and study management.
Location:
Indianapolis, IN - Hybrid
Travel:
Minimal 25% Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification.
- 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
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All…
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