Clinical Study Management Coordinator

Elanco; Fort Dodge (IA); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (US)

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco in Fort Dodge, IA is seeking a Study Management Coordinator in Clinical Development to provide administrative support for regulated and non-regulated studies, focusing on data management, QA, and system maintenance for EDC and audits.

You will contribute to upholding GLP standards, assist in study protocols, vendor coordination, and records management, while supporting training and continuous improvement within the Clinical Development Sciences team.

Qualifications

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Animal Science, Veterinary Medicine).
• 2–5 years of experience in a GLP-regulated environment, preferably in Quality Assurance or Study Management.

Responsibilities

• Assist in preparation and review of study protocols, data capture forms, amendments, and deviations; guide study personnel on regulatory requirements (GLP).
• Facilitate EDC systems and oversee indexing, QC, and review of study files for completeness and accuracy.
• Manage external vendors, especially those supplying data for GLP studies, and assist with Animal Care and Use Protocols (ACUPs).
• Maintain records for all clinical studies (equipment calibration, maintenance, room monitoring) and support GLP compliance and inspections.
• Provide training and guidance to new and existing study personnel and stay current with GLP regulations.

Skills

Quality Assurance

Study Management

GLP

Regulatory knowledge

Documentation

Electronic Data Capture (EDC)

Education

Bachelor's degree in a scientific discipline

MS degree in a relevant scientific discipline

Tools

Electronic Data Capture (EDC) systems

Job description

Elanco in Fort Dodge, IA is seeking a Study Management Coordinator in Clinical Development to provide administrative support for regulated and non-regulated studies, focusing on data management, QA, and system maintenance for EDC and audits.

You will contribute to upholding GLP standards, assist in study protocols, vendor coordination, and records management, while supporting training and continuous improvement within the Clinical Development Sciences team.