Research Scientist – Clinical Study Management

Role Summary

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.

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.

Qualifications

• 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.
• Required: 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.
• Required: Background with both USDA and EU Regulatory guidelines.
• Preferred: Experience with clinical study management in the Animal Health industry is highly desired.
• Preferred: Strong organizational and time management skills.
• Preferred: Advanced ability to define problems, collect data, establish facts, and draw valid conclusions.
• Preferred: Experience with biological vaccines, small molecules, and large molecules.
• Preferred: Experience with or willingness to gain experience with Pain and Dermatology models.

Additional Requirements

• Travel: Up to 10%
• Location: Fort Dodge, Iowa