Research Scientist – Clinical Study Management 

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: Research Scientist – Clinical Study Management 

The Research Scientist – Clinical Study Management position is responsible for the management of pivotal, regulated and non-pivotal studies at Elanco sites and Contract Research Organizations.

You will work collaboratively to support experimental design and scientific interpretation of study results, and production of any materials for patents or publications.

Your Responsibilities: 



* Oversee Study Design and Execution: 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.


* Ensure Comprehensive Regulatory Compliance: 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.


* Manage End-to-End Study Documentation: 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.


* Facilitate Cross-Functional Coordination & Communication: 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.


* Contribute to Scientific Advancement & IP: Support the generation of potential patents and publications based on study findings, leveraging study results to advance scientific knowledge and intellectual property within Elanco.

 

What You Need to Succeed (minimum qualifications): 



* MS with 4+ years, BS with 7+ years of experience, or Doctorate level education (e.g., PhD, DVM, MD) with 2+ year...