Clinical Project Manager, medical device - Hayward, CA

Description

• Participate in the development and implementation of effective clinical study protocols for company products
• Establish and implement clinical research procedures and policies
• Work with Regulatory Affairs staff in providing accurate and timely reports such as annual reports, safety reports and study summaries for FDA submissions or other regulatory documents
• Manage relationships with external Clinical Research Organizations, Data Management companies, monitors and consultants
• Support company goals and objectives, policies and procedures, Good Clinical Practices, MDD, FDA, ISO and QSR regulations

• BS or RN required
• 5+ years of industry experience in clinical trials
• 2+ years of clinical trial management experience with medical device company
• Experienced with cardiovascular related clinical trials
• International and domestic clinical trial experience
• Ability to travel up to 25% during occasional peak periods