Quality Review Specialist
- Employer: IQVIA
- Location: Bloemfontein
- Employment Type: Full-Time (Home-Based)
- Job Reference: R1553168
Job Purpose
The Quality Review Specialist is responsible for conducting internal Data Management Quality Reviews to ensure compliance with business, client, and regulatory requirements. The role focuses on quality assurance, compliance monitoring, risk identification, corrective action management, trend analysis, and continuous improvement within clinical research and data management processes.
Key Responsibilities
Quality Reviews and Compliance
- Conduct internal Data Management Quality Reviews.
- Ensure compliance with business unit, customer, and regulatory requirements.
- Identify and communicate recurring findings and errors to operational teams.
- Review and evaluate corrective and preventative action plans (CAPA).
- Ensure non-compliance issues are documented and addressed appropriately.
Quality Monitoring and Reporting
- Monitor and report quality and compliance issues to management.
- Collect, analyze, and report quality metrics.
- Ensure reporting is completed within regional timelines.
- Maintain accurate quality review documentation.
Data Analysis and Trend Identification
- Review aggregated quality review data.
- Analyze portfolio-level trends and identify recurring quality concerns.
- Review study-level error rates.
- Engage with study teams to discuss corrective actions and quality improvements.
Training and Continuous Improvement
- Liaise with training teams to update training materials and programs.
- Recommend improvements to quality management processes.
- Independently develop and propose solutions to quality-related issues.
- Support continuous improvement initiatives.
Leadership and Mentoring
- Provide expert quality review guidance.
- Mentor and support junior Quality Review staff.
- Promote quality standards and best practices across teams.
Minimum Requirements
Education
One of the following is required:
- Bachelor’s Degree in:
- Clinical Sciences
- Biological Sciences
- Mathematical Sciences
- Related scientific field
OR
- Nursing qualification with relevant experience.
Experience
- Minimum 5 years of clinical trials experience within a similar function.
- Experience managing multiple projects simultaneously.
- Experience across the full data management study lifecycle.
- Experience working on large clinical trials involving more than 1,000 patients.
- Experience participating in customer negotiations and bid defense meetings.
- Proven quality management and compliance experience.
Required Knowledge and Skills
Technical Knowledge
- Medical terminology exposure.
- Clinical research processes.
- Clinical trial data management.
- Quality assurance and compliance principles.
- Regulatory requirements within clinical research.
Professional Skills
- Excellent organizational skills.
- Strong communication skills.
- Leadership and mentoring abilities.
- Advanced computer skills.
- Strong analytical and problem-solving abilities.
- Exceptional attention to detail.
Personal Competencies
- Ability to work independently.
- Initiative in identifying and resolving problems.
- Ability to build and maintain professional relationships.
- Strong stakeholder management skills.
- Ability to manage competing priorities and deadlines.