Clinical Quality Assurance Specialist

Clinical Quality Assurance Specialist

Curium

France or Remote

KEY RESPONSIBILITIES

Quality Oversight & Compliance

• Monitor clinical trials and processes to ensure compliance with regulatory requirements and industry standards.
• Conduct audits of clinical documentation, investigator sites, vendors, and systems.
• Communicate compliance risks to senior management and support responses to regulatory inspections.

Process Improvement & Data Analysis

• Analyze quality data to identify trends and areas for improvement.
• Lead root cause analyses and implement corrective and preventive action plans.
• Develop and monitor quality metrics to support continuous improvement initiatives.

Training & Collaboration

• Provide training to clinical teams on quality processes and compliance requirements.
• Collaborate with internal and external stakeholders to align quality strategies with organizational goals.
• Promote a culture of quality awareness and improvement across the organization.

Documentation & Reporting

• Maintain quality management databases and prepare reports on quality performance.
• Ensure timely documentation of clinical policies, procedures, and regulatory submissions.
• Support electronic health record implementation and manage clinical quality systems (e.g., VEEVA TMF).

REQUIREMENTS

Education and Experience(s)

• Bachelor's degree in healthcare administration, nursing, or a related field.
• Minimum of 3 years in clinical quality management, including experience with audits and regulatory inspections.

Required skills/hard skills

• Proficiency in data analysis, electronic health records (e.g., VEEVA TMF), and quality management systems.
• Regulatory Knowledge: Strong understanding of industry standards, compliance requirements, and guidance documents.

Preferred skills/Soft skills

• Exceptional communication, problem-solving, and organizational abilities; adept at managing multiple priorities.
• Experience in handling confidential information, fostering teamwork, and participating in professional development activities.

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