Clinical Quality Assurance Manager - Palo Alto, United States - Advanced Clinical

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

• 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)

Experience

• 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)

EDUCATION

• Minimum of Bachelors Degree in a scientific discipline required