Ellen Benoit Email & Phone Number

Sunnyvale, California, United States

Mechelen, Belgium

Provide strategic direction for clinical validation studies of molecular diagnostic tests in oncology and infectious disease therapeutic areas, including budget forecasting, staff training and process improvements. Build efficient, compliant clinical processes focused on meeting aggressive project timelines.

Santa Clara, California

Serve as key team member to develop and market medical devices. Direct a team of up to 25 staff members. Formulate strategies to ensure department operations align with overall business objectives.

Santa Clara, California

Establish quality assurance department with focus on quality improvements through training, education and compliance. Managed team of 10 employees. Interpret and formulate policies and operational procedures related development of high risk medical devices to promote product quality and efficacy.

Redwood City, California

Conduct audits of clinical trial site and third party vendors for assessment of compliance with federal Food and Drug Administration (FDA) regulations. Make recommendations for process improvements.

Chicago, Illinois

Sponsor, manage and coordinate activities relating to third party audits of suppliers and clinical research studies. Evaluate effectiveness of quality systems and programs.

Santa Clara, California

Design, manage and execute domestic and international clinical studies of medical devices. Generate clinically and scientifically sound and statistically analyzed data to confirm performance claims supporting regulatory submissions.

Santa Clara, California

Establish an internal simulated customer testing laboratory aimed at data collection for use in poster presentations, white papers and customer complaint investigations.

Bachelor Of Arts (Ba), Management

Certificate, Clinical Trials Design And Management

Laboratory Medicine