Clinical QA Manager
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The Opportunity
Description
We're looking for a Clinical QA Manager, working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States.Job description:
- Chairs the Regulatory Authority Facilitation Team, and ensures that company clinical facility and clinical sites are prepared for clinical inspections and the inspections are successfully facilitated.
- Writes Inspection Readiness Plans as necessary.
- Facilitates sponsor and site inspections as necessary.
- Manages the Clinical Document Audit function, and plans, prepares, performs, and reports on CQA audits of Clinical Study Reports and Trial Master Files.
- Develops Study Audit Plans and prepares, performs, and reports on CQA audits of investigator sites.
- Plans, prepares, performs, and reports on CQA audits of internal processes.
- Provides GCP and Lessons Learned training.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
- BS or MS degree in relevant field
- 4-7 years of experience in Clinical Quality Assurance methods and processes in industry setting strongly preferred
- Related experience (for example, several years of clinical research study monitoring with knowledge of CQA processes) will be considered in lieu of direct CQA experience
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
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