Study Management Coordinator - Clinical Development

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!

This position provides critical administrative assistance for regulated (including GLP) and non-regulated clinical studies, focusing on meticulous data and record management, quality control, and system maintenance for electronic data capture and audits. As a Study Management Coordinator, you will be part of the Clinical Development Sciences function, playing a key role in upholding the rigorous quality standards essential to the integrity and success of our clinical studies.

• Study Assistance & Quality Assurance:
  Assist in the preparation and review of study protocols, data capture forms, amendments, and deviations; provide guidance to study personnel on regulatory requirements (e.g., GLP); and uphold rigorous quality standards to ensure data integrity and consistency.
• Documentation & Records Management:
  Facilitate Electronic Data Capture (EDC) systems and oversee the indexing, QC, and review of study files to ensure completeness and accuracy.
• Vendor and Protocol Management:
  Manage external vendors, particularly those providing data for GLP studies, and aid in the preparation of Animal Care and Use Protocols (ACUPs).
• Compliance & Inspection Readiness:
  Maintain a comprehensive overview of records for all clinical studies (including equipment calibration, maintenance, and room monitoring), assist in maintaining GLP compliance for laboratory equipment, and aid in facility inspections and QA audits.
• Training & Continuous Improvement:
  Provide guidance to new and existing study personnel, stay current with evolving GLP regulations and industry best practices, and facilitate the resolution of GLP-related issues identified during study conduct.

• Education:
  
  Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Animal Science, Veterinary Medicine).
• Experience:
  
  2-5 years of experience in a GLP-regulated environment, preferably within a Quality Assurance or Study Management role.
• Key Regulatory Knowledge: A thorough understanding of FDA 21 CFR Part 58 and/or OECD GLP Principles and familiarity with other relevant regulations (e.g., Animal Welfare Act, specific industry guidelines).

• Experience with clinical study management or coordination in the Animal Health industry is highly desired.
• Strong attention to detail and ability to identify non-compliance issues.
• Exceptional organizational skills and ability to manage multiple tasks and priorities.
• Excellent written and verbal communication skills for preparing reports, SOPs, and training materials.
• Thorough knowledge and experience in organizing various clinical functional groups including regulatory, clinical laboratory, clinical execution, veterinary services, and animal care personnel and ability to work effectively in a team.
• E…