Lead Clinical Trial Auditor- Remote Field Based (M
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Chicago, IL 60629
Additional Locations: US-FL-Miami; US-GA-Atlanta; US-IL-Chicago; US-IN-Indianapolis; US-NC-Raleigh/Durham; US-NC-Winston Salem; US-OH-Cincinnati; US-OH-Columbus/Zanesville; US-PA-Philadelphia; US-SC-Columbia; US-TX-Austin; US-TX-Fort Worth; US-TX-Houston
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
- This position is a remote field-based role with a preference to be located in the Midwest or South. Due to travel requirements of the role, candidates need to live close to a major airport.
About Clinical Quality Assurance:
This team supports the internal clinical quality assurance program and quality systems for the Cardiac Rhythm Management division of Boston Scientific. This includes clinical compliance (GCP, ISO, US & OUS regulations), internal and external quality audits, Inspection Readiness program, and supporting clinical and acquisition integration.
About the role:
The Principal/Lead Clinical Trial Auditor assists the Quality Assurance team and Clinical Research with the internal quality assurance program for the assigned business area. Serves as Clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
Your responsibilities include:
- Participate on clinical project teams, influencing clinical teams toward a state of inspection readiness at all times.
- Serve as lead auditor. Plans, schedules, and conducts internal and external quality assurance audits of systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
- Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
- Review, revise, update and maintain Clinical AVL and manages updates to the clinical vendor audit database.
- Assess sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures.
- Assess the accuracy, validity, and quality of the scientific data generated during clinical trials
- Participate in problem-solving with project teams at investigator sites.
- Communicates observations to clinical investigators, clinical program managers, directors, and management.
- Document audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed.
- Ensure tracking of audit findings.
- Contribute to the development of audit procedures and processes.
- Assist clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
- Support the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices.
- Assist in preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings
- Keep abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
- Support to the Clinical organization in meeting BSC Quality system requirements
- May support clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements.
- Support clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings.
- Plans, schedule, and conduct vendor audits.
What we are looking for:
- Bachelor’s degree in Life Sciences or related degree
- 6+ years’ combined experience in clinical research and Quality Assurance
- 2-3 years direct clinical quality (GCP) auditing experience
- Previous experience in medical device and/or pharmaceutical industry in an area regulated by GCP regulations and guidelines
- Expected travel is 25% (one week per month, 2-4 days). However, travel could increase to 50% during peak times and may include international travel.
- Master’s degree
- Previous experience with ISO 14155 and/or 21CFR812
- Previous auditing experience of human subject clinical trials strongly preferred.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Requisition ID: 447655
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran