IQVIA, a global leader in clinical research services and healthcare intelligence, is hiring an Associate Quality Review Specialist in Bangalore, India and Bloemfontein, South Africa. This full-time position offers the opportunity to work with cutting-edge clinical data, ensure compliance with regulatory standards, and contribute to high-quality outcomes in life sciences research.
As an Associate Quality Review Specialist, you will play a key role in maintaining data integrity, identifying trends, and supporting corrective and preventative actions (CAPA) to enhance operational quality.
Primary Keywords: Associate Quality Review Specialist, Clinical Data QA, Data Management Quality Review
Long-tail Keywords: QA specialist jobs in Bangalore, Clinical Data Management careers in India, Regulatory compliance jobs in life sciences
Key Responsibilities
- Conduct internal Data Management Quality Reviews to meet business, client, and regulatory requirements.
- Identify recurring findings/errors and communicate effectively with operational teams.
- Participate in the review and implementation of corrective/preventative actions (CAPA).
- Document and report quality/compliance issues related to product, process, or quality systems to Management.
- Collect and report quality metrics as required.
- Maintain knowledge of applicable regulatory and Sponsor guidelines and review techniques.
- Analyze aggregated QRP information to identify portfolio-level trends.
- Monitor study-level error rates and liaise with study teams to discuss CAPA.
- Coordinate with Training Teams to update training programs as necessary.
Required Qualifications
- Education: Bachelor’s degree in clinical, biological, or mathematical sciences, nursing, or related field. Equivalent combination of education, training, and experience is acceptable.
- Skills:
- Exposure to medical terminology
- Strong organizational, communication, and leadership skills
- Excellent computer proficiency
- High attention to detail and problem-solving ability
- Ability to work independently and maintain effective relationships with colleagues and clients
Physical Requirements
- Frequent telephone and face-to-face communication
- Extensive keyboard use
- Regular extended periods of sitting
Benefits
- Opportunity to work with a global leader in clinical research
- Exposure to international regulatory standards
- Professional growth and training opportunities
- Competitive salary and benefits