Study Management Coordinator - Clinical Development

Elanco•Fort Dodge, IA

5d•Onsite

About The Position

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.

Requirements

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 within a Quality Assurance or Study Management role.
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).

Nice To Haves

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.

Responsibilities

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.
Facilitate Electronic Data Capture (EDC) systems and oversee the indexing, QC, and review of study files to ensure completeness and accuracy.
Manage external vendors, particularly those providing data for GLP studies, and aid in the preparation of Animal Care and Use Protocols (ACUPs).
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.
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.