The Senior Scientist role is designed to support the regulatory approval of new companion animal and livestock products by designing, coordinating, monitoring, and reporting on clinical laboratory and field studies. This involves ensuring compliance with Good Clinical Practice (GCP) and occasionally Good Laboratory Practice (GLP) standards, leading clinical study teams, and acting as the clinical representative in project teams.
Requirements
- Understanding of GCP Good Clinical Practices guidelines.
- GLP Regulations
- Good Clinical Practice (GCP)
- ICH GCP Guidelines
- Protocol Development
- Data Analysis
- Medical Writing
Responsibilities
- Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and the study protocol/related documentation.
- Plan and coordinate the monitoring and data management activities of each study.
- Ensure that the study is conducted according to legal requirements, GCP, and the applicable internal policies and procedures.
- Prepare the Final Study Report
- Works with Clinical Study Team for monitoring and data management tasks (e.g., User Acceptance Test of electronic CRFs)
- Conduct quality control inspections of study protocol, study documentation files and reports.
- Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.
Other
- Doctor of Veterinary Medicine, OR equivalent veterinary degree
- One year in clinical research or similar research role.
- Experience in a clinical study related role.
- Travel Requirements: 25%
- Flexible Work Arrangements: Hybrid
