Director, Clinical Research

 

Summary:
The Director, Clinical Research will be responsible for the overall management and monitoring of multicenter domestic and international clinical trials and will ensure regulatory compliance for clinical trials. Duties include supervision of clinical research associates and third party Clinical Research Organizations (CRO), as well as site monitoring, oversight of on-time scheduling of follow-up visits and completion and submission of corresponding documentation. The position will also require oversight of several committees supporting the clinical trial. The Director, Clinical Research will prepare study progress reports, clinical reports, and other essential clinical documentation as may be necessary for regulatory and/or company management.

Experience:
Minimum of 10 years direct experience in a medical device or drug development clinical research setting. Medical device clinical research experience preferred.

Requirements:          

• Bachelor’s degree in life science or closely-related scientific discipline required. Master’s degree preferred.
• Working knowledge of GCP and current FDA standards.
• Demonstrate ability and desire to function well in a fast-paced, changing interactive environment.
• Must possess a high degree of integrity, professionalism and the ability to establish credibility across all levels of the organization.
• Excellent listening and verbal and written communication skills are essential.
• High proficiency with Microsoft Office applications (Word, Excel and PowerPoint).

If you are interested in this position, please email your resume and cover letter to careers@uptakemedical.com.