GLP Study Management Coordinator

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

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.