Clinical Quality Assurance Manager
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: October 31, 2024
Job 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 - $170,000All Other US Locations
(Outside of SFBA): $116,000 - $145,000Benefits 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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Keywords: Shockwave Medical, Inc., Santa Clara , Clinical Quality Assurance Manager, Executive , Santa Clara, California
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