Advisor R&D

Elanco•Indianapolis, IN

12d•Hybrid

About The Position

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.

Requirements

Bachelor's degree in a science or health related field
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
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).

Nice To Haves

Experience supporting FDA and USDA inspections and audits, ensuring trial compliance with GCP and regulatory requirements.
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.

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.