Assoc Quality Review Specialist
Job description
Job Overview
Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations.
Essential Functions
• Ensure that recurring 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.
Qualifications
• Bachelor's Degree Clinical, biological, or mathematical sciences, or related field
• Equivalent combination of education, training, and experience in lieu of degree.
• Excellent organizational, communication, leadership, and computer skills especially Microsoft Excel. 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. Comprehensive understanding of clinical drug development process, thorough knowledge of the data management process. Knowledge of operating procedures and work instructions and the ability to apply them in practice.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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