Sr Clinical QA Analyst – Osseo

Delivering on the promise of medical innovation begins at Boston Scientific

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

General Summary:
Serves as clinical QA representative on clinical study 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.

Principal Duties and Responsibilities:
?Participates on clinical project teams throughout the conduct of the study and serves as a Clinical QA advisor.
?Plans, schedules and conducts GCP audits of investigator sites, study documentation, files, data, and vendors.
?Serves as audit team lead.
?Assesses compliance with the protocol and GCP/ICH regulations, and the accuracy, validity, and quality of the scientific data generated during clinical trials.
?Documents audit observations, evaluates impact, and prepares audit reports.
?Keeps the audit database current.
?Communicates observations to the clinical investigator, clinical program managers, directors and senior management.
?Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
?Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
?Assists the project team with FDA inspection preparation and participates in regulatory inspections.
?Prepares investigator sites for FDA or other regulatory agency inspections.
?Provides training at investigator meetings.
?Assists Clinical QA Managers with audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
?Engages, trains, and supervises contract auditors, as needed.
Working Conditions:
General office environment; up to 50% travel to investigator sites and clinical research vendors, meetings and other BSC facilities.

Minimum Education & Experience:
?Bachelor’s degree in the Life Sciences
?Minimum 5 years’ experience in medical device or pharmaceutical industry.
?3+ years Clinical QA and/or compliance experience.
?1+ years auditing experience; international experience a plus.
?In-depth knowledge of Good Clinical Practices (FDA and ICH) and 21CFR Part 11 with respect to clinical processes and systems.
?Familiarity with US FDA regulations, EU Directives, HIPAA and Subject Data Protection regulations and laws.

Competencies:
?Mature, self-confident professional able to deal with difficult situations in a diplomatic manner.
?Strong verbal and written communication skills.
?Detail oriented and good problem solving ability.
?Able to work on project teams and with multiple projects.
?Able to develop good interpersonal relationships with medical professionals and interact with all levels of management.
?Strong computer skills with use of MS Office, Word, Excel, ACCESS, and PowerPoint. Experience with audit databases preferred.

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