Clinical Quality Assurance Manager

3 days ago

Santa Clara, California, United States Shockwave Medical Full time
Job Title: Clinical Quality Assurance Manager

Shockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. We are seeking a highly skilled Clinical Quality Assurance Manager to join our team.

Job Summary:

The Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process. This role will support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed.

Key Responsibilities:
  • 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
Requirements:
  • 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

Shockwave Medical is an EEO Employer

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