Study Director / Technical Assistant - Non-clinical Toxicity studies

Eurofins

Job details

Job Description

2.0 KEY RESPONSIBILITIES

2.1 Study Leadership and Regulatory Compliance

Serve as Study Director, Principal Investigator, or Technical Assistant for non-clinical toxicity studies
Ensure full compliance with GLP, OECD, ICH, FDA, and EPA guidelines, as well as sponsor-specific requirements
Lead all aspects of study execution, including planning, conduct, oversight, data interpretation, and comprehensive reporting
Demonstrate expertise in GLP-compliant non-clinical toxicity study design and execution
Administer test items via multiple routes of exposure with proficiency and precision

2.2 Data Management and Scientific Reporting

Conduct thorough review of study data to identify deviations and inconsistencies
Evaluate study results objectively and prepare high-quality study reports, amendments, and responses to sponsor inquiries
Ensure timely and accurate submission of all scientific documentation

2.3 Cross-Functional Coordination and Stakeholder Management

Coordinate effectively with sponsors, pathology, analytical, bioanalytical, veterinary, and quality assurance teams
Maintain adherence to study timelines and deliverables
Participate in sponsor meetings and provide regular study updates
Support regulatory submission activities

2.4 Core Competencies