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About the position
BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role, the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance oversight and management activities of clinical trial operations to ensure BostonGene's trials and services are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and BostonGene policies and procedures.
Responsibilities
- Serve as the GLP/GCP subject matter expert for cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs, and ICH Guidelines.
- Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GLP/GCP.
- Interpret regulations, as appropriate for the phase of development.
