Clinical Quality Assurance Manager

Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

• Act as a Clinical Quality Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
• Develop audit management plans and audit strategy for ongoing clinical trials
• Prioritize audit strategies for GCP programs  
• Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines
• Participate or lead in the development of departmental standard operating procedures, work instructions, forms, and templates
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
• Conduct training for staff (GCP, Inspection Readiness training, etc.)
• Prepare and support regulatory inspections
• Write and review/revise Standard Operating Procedure (SOPs)
• Responsible for initial and ongoing audit of clinical vendors such as CRO, imaging core lab, central laboratory and other vendors as needed
• Identifies and escalates site, vendor and study related issues to management, as appropriate
• Responsible to recruit, train, and mentor Clinical Quality resources
• Other duties as assigned.

• This position requires a bachelor's degree.
• 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred 
• 5+ years of experience in Quality in a related industry
• 2+ years of people management or relevant experience
• Experience conducting audits of vendors and investigative sites
• Experience hosting and interacting with regulatory authority inspectors
• Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
• Experience authoring and revising SOPs and procedures
• Thorough knowledge and application of Good Clinical Practice (GCP) i.e. FDA, ISO, MDR
• Knowledge and experience in supporting device pre- and/or post-market clinical studies  
• Medical Device experience is preferred
• Ability to travel up to 30%-40% of time domestically and internationally
• Excellent written and verbal communication skills
• Basic understanding of peripheral and coronary artery disease and therapies preferred 
• ACRP or SOCRA certification preferred
• Ability to work in a fast-paced environment while managing multiple priorities across multiple projects 
• Operate as a team and/or independently while demonstrating flexibility to changing requirements
• High attention to detail and accuracy

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer