GLP Study Management Coordinator - Clinical Development

Iowa Ag; Fort Dodge (IA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

2 weeklong shutdowns (mid-summer and Y

6% 401K matching

Job summary

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

The role ensures protocol review, vendor oversight, GLP compliance, records management, and inspection readiness, with collaboration across regulatory, clinical, veterinary services, and lab teams.

Qualifications

• Experience in GLP-regulated environment is required.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication for reports and SOPs.

Responsibilities

• Study Assistance & Quality Assurance: assist in protocols, data capture forms, amendments, deviations and regulatory guidance.
• Documentation & Records Management: manage EDC systems, indexing, QC and study file reviews.
• Vendor and Protocol Management: oversee external vendors providing GLP data and assist in animal care protocol prep.
• Compliance & Inspection Readiness: maintain records and GLP compliance, support facility QA audits.
• Training & Continuous Improvement: train staff and stay current with GLP regulations.

Skills

Quality Assurance

Study Management

GLP Regulations

Documentation

Education

Bachelor's degree in a scientific discipline

Job description

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

The role ensures protocol review, vendor oversight, GLP compliance, records management, and inspection readiness, with collaboration across regulatory, clinical, veterinary services, and lab teams.