Senior Associate-Clinical Operations jobs in United States
cer-icon
Apply on Employer Site
company-logo

Elanco · 2 weeks ago

Senior Associate-Clinical Operations

Elanco is a global leader in animal health dedicated to innovation and delivering products for animal care. In the role of Clinical Research Associate, you will advance Elanco’s product pipeline by monitoring clinical studies and ensuring compliance with regulatory standards.

ManufacturingPetSupply Chain Management

Responsibilities

Proactively identify solutions and remove barriers to study progress
Work effectively across Elanco R&D teams and external partners to support shared deliverables
Foster a positive work environment aligned with company objectives and values
Promote innovation by challenging yourself and others to deliver strong technical outcomes
Demonstrate Elanco values of integrity, respect, and excellence while modeling the behavioral pillars of involve, deliver, innovate, and own
Organize work to deliver high-quality, timely, and cost-effective outcomes
Provide information to support accurate project and budget forecasting
Independently oversee clinical studies in companion and farm animals, ensuring all work is conducted, recorded, and reported in compliance with protocols, SOPs, VICH GCP, and regulatory standards
Prepare and ship study site documentation, regulatory materials, and correspondence
Verify drug accountability during initiation and closeout visits
Interact with investigator sites and third-party contract facilities
Verify study data using approved Data Management tools and monitoring processes to ensure data integrity
Manage query communication with study sites
Support QA audits as needed
Facilitate site recruitment, site training, study initiation, in-life monitoring, and close-out activities
Collaborate across R&D and commercial teams based on project phase and needs
Assist in preparing submissions and dossiers for global regulatory agencies

Qualification

Clinical researchRegulatory complianceData verificationStudy monitoringVICH GCPQA auditsCommunication skillsOrganizational skillsCollaboration skills

Required

Education: Bachelor's degree in a scientific, veterinary, or related field, or equivalent experience
Experience: Experience in clinical research, veterinary/animal health, laboratory science, or related regulated study environments
Top Skills: Study monitoring, regulatory compliance, data verification and documentation quality

Preferred

Experience with VICH GCP or similar regulated environments
Prior work with companion animal or food animal clinical studies
Familiarity with QA audits and regulatory submissions
Experience interacting with CROs, clinical investigators, or farm operations
Strong organizational, communication, and collaboration skills

Company

Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.

Funding

Current Stage
Public Company
Total Funding
$252.86M
Key Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M

Leadership Team

leader-logo
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
linkedin
leader-logo
Jennifer Black
Senior Director, Global Indirect Procurement
linkedin
Company data provided by crunchbase