Offer summary

Qualifications:

Bachelor’s degree required, 10 years clinical research experience, 5+ years experience in Quality field, 1-3 years project management experience, Knowledge of GCP and regulations.

Key responsabilities:

Ensure compliance with regulatory standards

Conduct internal and external audits

Prepare and support regulatory inspections

Develop audit strategies for trials

Recruit, train, and mentor team members

Job description

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.

Position Overview

The Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process, support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers and is critical to the success of the business.

Essential Job Functions

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.

Requirements

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

San Francisco Bay Area (SFBA) Market Range: $136,000 - $170,000

All Other US Locations (Outside of SFBA): $116,000 - $145,000

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

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