Base: $60,800.00 - $91,200.00; bonus/equity: not s...
Fully remote
6 years relevant work experience
Fda regulations for drugs devices biologics
Clinical trial monitoring and auditing experience
The Quality Assurance Manager position at the University of Kansas Cancer Center involves overseeing compliance with clinical trial standards and regulations, ensuring quality in trial processes. The role requires collaboration with various teams and external auditors, emphasizing a commitment to patient safety and innovative care
Job Summary
The Quality Assurance Manager ensures clinical trials are conducted in accordance with Institutional and Regulatory guidelines to achieve quality data and positive outcomes.
This role involves performing internal audits, hosting external audits from pharmaceutical sponsors and CROs, and serving as the primary contact for FDA inspections.
The position offers comprehensive benefits including health insurance starting day one, generous retirement contributions, and paid time off beginning upon hire.
Matching Summary
Match Score: 85
The Quality Assurance Manager position at the University of Kansas Cancer Center involves overseeing compliance with clinical trial standards and regulations, ensuring quality in trial processes. The role requires collaboration with various teams and external auditors, emphasizing a commitment to patient safety and innovative care.
Salary
Base: $60,800.00 - $91,200.00; Bonus/Equity: Not specified; Benefits: Health dental vision life disability retirement included
Skills & Requirements
Must-have
6 years relevant work experience
FDA regulations for drugs devices biologics
Clinical trial monitoring and auditing experience
CAPA plan preparation and response
Internal audit of Investigator Initiated Clinical Trials
Nice-to-have
Experience with FDA inspections and sponsor audits
Strong problem solving and time management skills
Excellent interpersonal and communication abilities