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Principal Clinical Trial Auditor Job

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Date: Mar 15, 2019

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations:  Remote home based role anywhere in USA

 

 

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 can be field based anywhere in the U.S.

 

About this role:

The Principal Clinical Trial Auditor assists 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:

  • Participates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times
  • Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
  • Serves as lead auditor
  • 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.
  • Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures
  • Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials
  • Participates in problem-solving with project teams at investigator sites
  • Communicates observations to clinical investigators, clinical program managers, directors, and management
  • Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed
  • Ensures tracking of audit findings
  • Contributes to the development of audit procedures and processes
  • Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
  • Supports the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices
  • Assists in preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings
  • Keeps 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
  • Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input
  • 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.
  • Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings.
  • Plans, schedules, and conducts vendor audits

 

 

What we are looking for:

Basic Qualifications:

  • Bachelor’s degree in Life Sciences and 6 years of experience or Master’s degree and 4-7 years of experience
  • Minimum 6 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; clinical QA and/or compliance experience
  • Minimum 3 years direct clinical quality (GCP) auditing experience
  • Travel up to 50% can be expected including international

 

Preferred Qualifications

  • Medical device experience desired
  • GCP/auditing certification preferred

 

Quality System Requirements:

  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

 

 

 

 

 

 

 

About us

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.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 443457

 


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