Study Director
2 weeks ago
We are hiring a Study Director for a preclinical contract research organization (CRO) that provides services in the fields of drug, vaccine, and medical device development and testing. The company offers integrated preclinical drug development services including cellular and animal disease model design and development, non-GLP and GLP efficacy, toxicity, biodistribution, and product release studies in a broad range of animal species.
In this role you will:
• Serve as a Study Director for non-GLP and GLP-compliant Medical Device efficacy and toxicology studies.
• Be responsible for study design and execution.
• Supervise technical staff.
• Conduct data analysis and interpretation
• Prepare study reports in compliance with regulatory requirements.
• Study design, proposal preparation, and extensive interactions with sponsor representatives are essential functions.
• Other related duties as assigned.
Is this role right for you?
• Do you care deeply about documenting processes, and you are diligent?
• Do you pay attention to details, you are very organized, and meet deliverables in a highly dynamic working environment?
• Do you posess the ability to directing a management team to ensure the studies are of high quality, completed on time, and in compliance with regulations and procedures?
• Are you a great collaborator and team player?
Qualifications:
• A Master's degree or Ph.D. Biomedical Engineering, or a related field or a D.V.M./V.M.D.
• Research experience in small and large animal surgical studies.
• Experience as a Study Director for GLP-compliant studies is highly desirable.
• Excellent project scoping and management skills.
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