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- Identify and prioritize audit strategies for GCP programs
- Coordinate, plan, and/or conduct clinical study-related audits (Investigator Sites, Clinical Service Providers, Internal Systems, etc.)
- Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
- Conduct training for staff (GCP, Inspection Readiness training, etc.)
- Interview, select, and train employees
- Prepare and host regulatory inspections
- Write and review Standard Operating Procedure (SOPs)
- Minimum of 6 years of experience in FDA- and ICH-regulated clinical research in GCP QA
- Detailed knowledge of and ability to interpret/apply GCP, EU, FDA, and ICH regulations/guidelines
- Ability to critically analyze and communicate compliance-related information and present associated risks
- Ability to coordinate internal/contract auditors and conduct audits
- Experience auditing Investigator sites, Clinical Service Providers, and Internal Systems Audits
- Experience with regulatory inspection and inspection readiness
- Experience with Quality Management Systems
- Experience reviewing study-related documentation (protocols, clinical study reports, informed consents) and communicate findings to appropriate team members
- Ability to work independently, manage multiple priorities, and execute on goals
- Excellent interpersonal and written communication skills
- Strong analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Travel required – up to 20% (domestically and internationally)
- Minimum of Bachelor's Degree in a scientific discipline required
Clinical Quality Assurance Manager - Palo Alto, United States - Advanced Clinical
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Description
Manager, Clinical Quality
**Client is open to hiring CPM / CTM's or Clinical Operations individuals who are interested in Quality. Ideal experience in GCP is desired. This is an individual contributor role.
Responsibilities
Experience
EDUCATION