Essential Functions:

• Provide overall management for clinical trials as assigned
• Manage all aspects of trial budgets, costs, and site payments
• Originate clinical trial protocols and ancillary documents
• Provide project/study management and monitoring plans for projects
• Develop and maintain relationships with investigators, coordinators and site staff
• Ensure conformance with GCP, ISO, MDD, CFR and other regulations as necessary
• Investigate and solve problems that impact work processes and personnel in multiple departments
• Ability to develop presentation materials and make presentations to senior staff
• Assist with the planning, preparation and presentations at Investigator Meetings
• Ability to multitask business, clinical, product and physician requirements

Education/Experience:

• BS degree in life sciences plus 10 years of related work experience, MD or PhD preferred
• Experience developing and executing clinical programs for medical devices, including prior clinical trial project management

• Prefer MD orPhD. Minimum requirement: BS degree in life sciences plus 10 years of related work experience, or equivalent combination of education and experience

• Prior people management and clinical trial project management experience required

• Fluent in both written and spoken English