Study Management Coordinator - Clinical Development

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 65,000 - 96,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (US)

8-week parental leave

Employee Resource Groups (ERGs)

Annual bonus offering

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Study Management Coordinator – Clinical Development in Fort Dodge, IA. The role focuses on administrative support for regulated and non-regulated clinical studies, ensuring data integrity, quality control, and system maintenance across EDC platforms.

You will work within Clinical Development Sciences to uphold GLP standards, manage study documentation, and support QA audits while guiding study personnel and staying current with evolving regulations.

Qualifications

• Bachelor's degree in Biology, Chemistry, Animal Science, Veterinary Medicine or related field.
• 2-5 years of experience in a GLP-regulated environment.
• Knowledge of FDA 21 CFR Part 58 and OECD GLP Principles.
• Familiarity with Animal Welfare Act and industry guidelines.

Responsibilities

• Assist in study protocols, data capture forms, amendments, and deviations; guide personnel on regulatory requirements (GLP).
• Oversee Electronic Data Capture (EDC) systems and study file QC/review.
• Manage external vendors providing data for GLP studies and assist in ACUP preparation.
• Maintain records for clinical studies, equipment calibration, and QA audits for GLP compliance.
• Provide training and stay current with evolving GLP regulations and best practices.

Skills

Attention to detail

Organizational skills

Communication skills

Regulatory knowledge

Team collaboration

Education

Bachelor's degree in a scientific discipline

MS degree in a relevant scientific discipline

Job description

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: Study Management Coordinator – Clinical Development

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.

Your Responsibilities:

• 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.

What You Need to Succeed (minimum qualifications):

• 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).

What will give you a competitive edge (preferred qualifications):

• 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.
• Effective communication skills.
• An MS degree in a relevant scientific discipline.

Additional Information:

Travel: Up to 10%.

Location: Fort Dodge, IA, USA – On-Site Work Environment.

Don’t meet every single requirement? Studies have shown underrecognized 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:

• 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 #LI-MW1

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com.