Senior Clinical Quality Assurance Specialist

Recruiter: Spencer Gregory Hale

 

Senior Clinical Quality Assurance Specialist

 

About this role:

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Our Rhythm Management Clinical Quality Assurance team rigorously pursues adherence to good clinical practice within some of the most challenging clinical device trials conducted in pursuit of transforming lives with groundbreaking technologies that address irregular heart rhythms, heart failure and sudden cardiac arrest.

 

We are seeking an engaging and qualified Senior Clinical Quality Assurance Specialist who is aligned with our core values that define Boston Scientific culture and empower our employees: 

Caring - Meaningful innovation - High performance - Global collaboration - Diversity - Winning spirit.  Because a career with Boston Scientific is more than just a job. It’s personal. We’re committed to solving some of healthcare’s toughest problems – united by a deep caring for human life. If you’re a natural problem-solver with the imagination, courage, and spirit to make a meaningful difference in clinical quality, there’s no better place to build your career.

 

Your responsibilities include:

Clinical Compliance - Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

• Provide clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provide support and response to compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Support Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections as well as external audits and inspections
• Communicate with global clinical teams regarding clinical vendor compliance topics
• Keep abreast of and interpret current Clinical QS, worldwide Regulatory, and GCP requirements to situationally advise various stakeholders accordingly so to ensure human subject protection, data integrity and regulatory compliance in our clinical study conduct

 

Independent Auditing:

• Create risk-based study-specific audit plans; plan, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards
• Document and communicate audit observations to internal BSC stakeholders; evaluate impact and make recommendations for corrections and/or corrective actions.
• Evaluate responses to audit findings and ensure that appropriate corrections and corrective actions are timely initiated and completed, and audits are appropriately closed

 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements

• Support Clinical and QS team during External Inspections and Notified Body audits