Research Scientist – Clinical Study Management  jobs in United States
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Elanco · 4 months ago

Research Scientist – Clinical Study Management 

Elanco is a global leader in animal health dedicated to innovation and improving the lives of animals. The Research Scientist – Clinical Study Management role involves overseeing the design and execution of clinical studies, ensuring regulatory compliance, and managing study documentation while contributing to scientific advancements and intellectual property.

ManufacturingPetSupply Chain Management
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H1B Sponsor Likelynote

Responsibilities

Lead the design and execution of clinical studies, including GLP, GCP, pivotal and non-pivotal studies, acting as Study Director for GLP safety studies and Study Investigator for clinical studies, ensuring overall conduct and scientific integrity
Maintain rigorous compliance with Good Laboratory Practice (GLP) - 21 CFR Part 58, Good Clinical Practices (GCP), and all applicable internal and external guidelines (e.g., SOPs, HSE, Animal Welfare, IACUC approvals), including managing protocol excursions and corrective actions
Drive the development and completion of study protocols and final reports, support the creation and maintenance of all study-related SOPs, templates, and forms, and ensure the accurate interpretation, analysis, documentation, and secure archiving of all raw data and specimens
Coordinate with study staff for protocol training and execution preparation, organize IVP supply management, and ensure continuous, clear communication between the Study Director, Sponsor Representative, Investigator, Clinical team, QA, and Study Monitor
Support the generation of potential patents and publications based on study findings, leveraging study results to advance scientific knowledge and intellectual property within Elanco

Qualification

Clinical Study ManagementLaboratory Practice (GLP)Clinical Practices (GCP)Regulatory ComplianceData AnalysisOrganizational SkillsTeam CoordinationTime ManagementProblem SolvingCommunication Skills

Required

MS with 4+ years, BS with 7+ years of experience, or Doctorate level education (e.g., PhD, DVM, MD) with 2+ years in a relevant industry
Experience managing clinical study initiation, execution, and completion and thorough understanding in coordinating various clinical functional groups including regulatory, clinical laboratory, clinical execution, veterinary services, and animal care personnel
Background with both USDA and EU Regulatory guidelines preferred

Preferred

Experience with clinical study management in the Animal Health industry is highly desired
Strong organizational and time management skills
Advanced ability to define problems, collect data, establish facts, and draw valid conclusions
Experience with biological vaccines, small molecules, and large molecules
Experience with or willing to gain experience with Pain and Dermatology models

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

Company

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

H1B Sponsorship

Elanco has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)

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

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