Full Job Description
Job Description
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.
Your Responsibilities:
• Plan, manage, and coordinate all phases of clinical trial activities, including study initiation, execution, and close-out.
• Support study teams by reviewing protocols, final reports, and assisting with data capture design and QA/audit responses.
• Perform or oversee monitoring duties, site recruitment, training, and compliance across assigned clinical sites.
• Collaborate cross-functionally across R&D, commercial, and external partners to drive project execution and alignment.
• Support budgeting, contracting, and invoicing efforts, and contribute to accurate project forecasting.
• Contribute to a high-performing, innovative team culture aligned with Elanco values and behavioral pillars.
• Participate in regulatory inspections (FDA/USDA) and communicate effectively with regulators, as needed.
• Mentor study monitors and administrators, and take on additional tasks as directed by leadership.
• Identify risks and implement proactive solutions to ensure timelines, quality, and compliance targets are met.
• Drive continuous improvement by evaluating study operations and recommending efficiencies in trial conduct and data quality.
• Ensure adherence to internal SOPs and evolving regulatory requirements across regions.
• Support or lead vendor selection and oversight, ensuring deliverables meet contractual and operational expectations.
Minimum Qualification (education, experience and/or training, required certifications)
• 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
• Required Experience: 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
• 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).
What Will Give You a Competitive Edge (Preferred Qualifications):
• 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.
Additional Information:
• Location: Indianapolis, IN - Hybrid
• Travel: Minimal 25%