Job Description
About the position We are seeking an engaging and qualified Principal Clinical Quality Assurance Specialist to focuses on oversight and support of clinical research quality, with a strong emphasis on Good Clinical Practice (GCP). The role operates as both an independent auditor and a consultative quality partner to clinical teams. This individual will routinely assess compliance at clinical investigator sites (hospitals and institutions enrolling human subjects), as well as internally within Boston Scientific, ensuring regulatory expectations, internal procedures, and best practices are met. The role exists within a small, specialized clinical quality group that is distinct from broader design or manufacturing quality teams. This is a high visibility hybrid position supporting a global Clinical team conducting investigational electrophysiology and cardiac rhythm management/diagnostic medical device studies at global sites. Responsibilities • Clinical Compliance: Hands-on partnership with Clinical for clinical quality consultation and inspection readiness: Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness Provides support and response to clinical quality, compliance and regulation questions including quality review of clinical study documents and related functional study plans Owns and/or supports management of internal clinical, external investigator site and clinical supplier nonconforming event management and CAPAs Supports Clinical Inspection Readiness program to include inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections Communicates with internal stakeholders regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs • Independent Auditing: Creates risk-based study audit plans; plans, schedules, conducts, provides internal oral debriefs and writes formal audit reports to internal stakeholders and leadership for internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational pre-market, post-market and post approval clinical studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures Documents evidence and provides rational and authoritative citations for audit observations of nonconformance; communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed Keeps abreast of and interprets current worldwide regulatory requirements and good clinical practice standards; advises various stakeholders regarding possible ramifications of regulatory changes • Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements: Demonstrate an unwavering commitment to patient safety and clinical quality by adhering to the Quality Policy and all documented processes and procedures, and maintaining a patient centric quality focus Supports Clinical and QS team during External Regulatory/Notified Body audits/inspections Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure Participates in clinical process improvement projects and initiatives Provides reviews and comments in relevant BSC procedure revisions Supports departmental, divisional, and corporate quality goals and priorities Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System. • Acquisition integration: Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data. Requirements • Minimum of a bachelor’s degree in Science, Health, Engineering, or a related field with minimum of 8 years’ experience in the m edical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 10 years of relevant clinical research experience • Demonstrated clinical research audit, compliance and related writing experience with one or more of the following: clinical trial primary research coordinator or monitor, GCP auditor, CAPA le
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