Clinical Quality Consultant at MEIRxRS / Med Exec Intl
San Francisco, CA 94112
About the Job
Clinical Quality Consultant
Location: San Francisco
Seeking a Clinical QA Consultant to support our ongoing clinical trials.
Responsibilities
- Build systems
- SOP infrastructure
- departmental structure for phase-appropriate Clinical Quality Systems in partnership with other functions
- Plan / Perform / manage risk-based clinical investigator site audits, vendor audits and internal
audits - Assist in formulating of and follow-up on corrective actions with internal and external
stakeholders - Develop and report quality metrics for Clinical Operations and Pharmacovigilance; use data and
other information to continuously improve Clinical Quality - Act as advisor for functional teams for Good Clinical Practices
- Perform Quality Review of Clinical documentation including but not limited to study protocols,
Investigator Brochures etc. - Coordinate and provide GCP Training for functional departments
- Assume a leadership role in preparing for Clinical and Pharmacovigilance inspections by FDA and
other Health Authorities - Co-Host GCP and PV inspections
Qualifications
B.S. degree preferably in a scientific discipline
8+ years of experience in the pharmaceutical/biopharma industry
6+ years of experience in Clinical Quality
Profound knowledge of regulations related to Good Clinical Practices and Pharmacovigilance
domestically and globally
Profound knowledge of regulations related to Good Clinical Practices and Pharmacovigilance
domestically and globally
Thorough understanding of clinical trials in a development (Phase I to III) environment
Experience in conducting and managing audits relevant to clinical development (investigator site
audits, supplier audits)
Experience in conducting and managing audits relevant to clinical development (investigator site
audits, supplier audits)
Experience with inspections (preparation, hosting, responses) by FDA and other Health
Authorities
Authorities
NO SPONSORSHIP AVAILABLE
Must be able to work as a W2
Green Card Holder or US Citizen required