Clinical Quality Lead
Behavioral Health Market Context
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Job Description
g, and Education
MS Degree
Minimum 7 years of clinical trial experience
Minimum 5 years of quality assurance experience
Experience with FDA, EMA, MHRA, PDMA inspections
In-depth knowledge of US and EU regulations and ICH GCP Guidelines
MS Degree
Minimum 7 years of clinical trial experience
Minimum 5 years of quality assurance experience
Experience with FDA, EMA, MHRA, PDMA inspections
In-depth knowledge of US and EU regulations and ICH GCP Guidelines
Qualifications
- •MS Degree
- •Minimum 7 years of clinical trial experience
- •Minimum 5 years of quality assurance experience
- •Experience with FDA, EMA, MHRA, PDMA inspections
- •In-depth knowledge of US and EU regulations and ICH GCP Guidelines
Benefits
Responsibilities
- •Serve as the primary Quality point of contact for assigned clinical trials
- •Lead GCP quality oversight and manage clinical trial audit programs
- •Drive investigation of trial quality events and oversee vendor performance