Research Scientist – Clinical Study Management

** At Elanco (NYSE: ELAN) – it all starts with animals!
**** 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+ 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.
** What will give you a competitive edge (preferred qualifications):
*** 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.
** Additional Information:
*** Travel:
Up to 10%

* Location:

Fort Dodge, Iowa
* Studies have shown under recognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
*** Elanco Benefits and Perks:
** We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
* Multiple relocation packages
*…