Assoc Dir, Clin Data Mgmt Quality FSP
Lead Functional Department of Data Management professionals to efficiently produce databases that meet customer requirements.
Primary point of contact for Customer on any quality related items
Provides oversight for activities performed by the Quality Management Team
Confirms that the processes as described in the Quality Oversight Plan are followed consistently and aligns with SOP and Quality Agreement where applicable
Identifies trends and makes recommendations to the operations teams when applicable
Reports quality metrics on portfolio level to cross organizational Senior Management team
Reviews corrective actions taken on study level and ensure the implementation of a strategy to implement corrective/preventative actions on a portfolio level where applicable.
Provides updates on CAPA progress to Customer and share corrective/preventative actions for review and discussion where appropriate
Act as the primary issue owner for any quality incidents logged in the IQVIA Quality Management System or agreed Sponsor system
Monitors customer Key Performance Indicators (KPIs) or Key Quality Indicator (KQI)
Monitors Trial Master File (TMF) compliance across the portfolio
Facilitate collective improvement of quality of delivery on portfolio level
Track and analyze collective metrics and trends to determine portfolio health and develop strategies to improve collective quality and performance
Provides leadership and encourage/support and drive to the Quality Management Team
Serve as Subject Matter Expert for DM Quality Delivery
Qualifications and Experience
Typically requires 7-10 years of prior relevant experience in Data Management or Quality Management. Substantial Project Management and People Management experience or combination of education, training and experience.
Knowledge, Skills and Abilities
Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
Excellent experience and organizational, communication, and demonstrated expert data management 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 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, SAE reconciliation, central laboratory, and/or new technology)
Knowledge ofoperating procedures and work instructions and the ability to apply them in practice
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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