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.
- Bachelor’s degree required. BS degree in scientific field of study is highly preferred but not required.
- 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