Clinical reputed company Assurance Manager

This a Full Remote job, the offer is available from: reputed company, Canada, California (USA) reputed company reputed company, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. reputed company aims to establish a new reputed company 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 reputed company The Clinical reputed company Assurance Manager will reputed company GCP and compliance-reputed company reputed company and audit of reputed company Clinical Studies in process, support and update procedure compliance with applicable regulations and reputed company clinical affairs initial and ongoing vendor audits as needed. This work is accomplished with minimal reputed company, requires frequent contact with reputed company customers and is critical to the reputed company of the business. Essential Job Functions

• reputed company as a Clinical reputed company reputed company on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
• reputed company audit management plans and audit reputed company 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 reputed company (GCP) guidelines
• Participate or reputed company in the development of departmental reputed company operating procedures, work instructions, forms, and templates
• Report audit findings to management with recommendations for reputed company 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 reputed company 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 reputed company issues to management, as appropriate
• Responsible to recruit, train, and mentor Clinical reputed company 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 reputed company, 2-3 years preferred
• 5+ years of experience in reputed company in a reputed company 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 reputed company (GCP) i.e. FDA, ISO, MDR
• Knowledge and experience in supporting device reputed company- 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 reputed company
• Operate as reputed company and/or independently while demonstrating flexibility to changing requirements
• High attention to detail and accuracy

San Francisco Bay Area (SFBA) Market reputed company: $136,000 - $170,000 reputed company Other US Locations (reputed company of SFBA): $116,000 - $145,000 Benefits reputed company offers a competitive total compensation package as reputed company as the following benefits and perks: Core Benefits: Medical, Dental, reputed company, reputed company-tax and Roth 401k reputed company with a fully reputed company match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance Perks: ESPP, reputed company App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards EEO Employer This offer from "reputed company" has been enriched by reputed company.com and got a 76% reputed company score. Apply tot his job Apply To this Job