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 Bachelor's Degree in a scientific discipline required

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