Quality Review Specialist
- Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations.
- 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.
- Liaise with Training Team to update training where needed. Train and Mentor junior Quality Review staff
- Independently bring solutions to the Quality Management Team. Provide comprehensive Quality Review expertise.
- Advanced English level (written and spoken).
- Minimum 5 years of Clinical Data Management experience, with 1-2 years in a quality function or equivalent combination of training and experience.
- Previous DOC/DTL/PCDA/LDM experience is preferred
- Knowledge: Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- Skills and Abilities: Excellent organizational, communication, and demonstrated expert data management skills (detail oriented).
- Ability to act independently and with initiative required to resolving problems
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Comprehensive understanding of clinical drug development process (detail oriented)
- Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic extensive knowledge, startup activities, SAE reconciliation, vendor management, and/or new technology)
- Knowledge of operating procedures and work instructions and the ability to apply them in practice
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.
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