Associate Quality Review Specialist
• Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations.
• Ensure that re-occurring findings/errors are communicated effectively with operational team.
• Participate in review of corrective/preventative actions.
• Assure recording of an appropriate response to any non-compliance, with corrective action and a timeframe for completion.
• Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to Management within specified regional timelines.
• Collect and report quality metrics as required to Management.
• Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques.
• Reviews aggregated information provided on the QRP and performs analysis and identification of trends on portfolio level.
• Reviews the error rate on study level and contact study teams where applicable to discuss CAPA.
• Liaise with Training Team to update training where needed.
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
• Medical terminology exposure
• Excellent organizational, communication, leadership and computer skills
• Ability to exercise excellent attention to detail
• Ability to act independently and with initiative required to resolving problems
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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