Clinical Trial Quality Control Manager (Site Oversight) - Remote

Primary Function:

• Conduct independent quality control assessments to confirm investigational sites execute clinical trials in accordance with protocols, GCP, and company procedures.
• Partner with Clinical Trial Managers and CRAs on follow-up actions to strengthen study execution.
• Report to the Executive Director, Head of US Clinical Operations, and work remotely with frequent travel to study sites.

Key Responsibilities:

• Develop and maintain study-specific QC plans, tools, and reports for risk-based assessments.
• Perform on-site and in-house QC reviews, including informed consent checks, safety reporting, and documentation.
• Track findings, support root cause analysis and CAPA, and contribute to inspection readiness.

Qualifications:

• Bachelor's degree in medical science or related field with 5+ years of clinical research experience, including QC oversight.
• Strong knowledge of ICH-GCP and applicable regulations; excellent communication and analytical skills.
• Ability to think strategically, demonstrate integrity, and resolve complex issues.

Compensation & Benefits:

• Base pay range from $140,000 to $160,000 per year, depending on location and experience.
• Additional compensation includes sign-on bonus, restricted stock units, and discretionary awards.
• Full benefits include 401(k), medical, paid time off, and parental leave.