Celeste Lombard

Experience

• 

  IQVIA

  Feb 2005 - Oct 2020

  • Conduct internal Data Management Quality Reviews to fulfil business unit, customer and regulatory requirements and expectations.• Ensure that recurring findings/errors are communicated effectively with the 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.• Review aggregated information provided on the QRP and performs analysis and identification of trends on portfolio level. Show less • Provide leadership to DM team.• Or serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 20 operations staff• (excludes DE), or serve in a leadership role to a specific DM Task.• With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership, and technical expertise to Operations team.• Manage delivery of projects through full data management process life-cycle.• With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify• Provide comprehensive data management expertise (including all operations tasks and DMP generation).• Perform comprehensive quality control procedures.• Independently bring project solutions to the CDM team.• Solves issues through using the global issue escalation/communication plan.• Understand and comply with core operating procedures and working instructions.• Meet objectives as assigned.• Develop and maintain good communications and working relationships with CDM team.• Interact with CDM team members to negotiate timelines and responsibilities. Show less

  • Associate Quality Review Specialist

    Oct 2019 - Oct 2020

  • Associate Clinical Data Manager

    Feb 2005 - Oct 2019

  • Data Management Team Lead

    Feb 2005 - Sept 2019

  • Associate Data Manager

    Aug 2011 - Jul 2015

  • Senior Clinical Data Coordinator

    Mar 2007 - Jul 2011

  • Associate Clinical Data Coordinator

    Aug 2006 - Dec 2006

  • Data Assistant, Clinical Data Services

    Feb 2005 - Jul 2006
• 

  Covance

  Nov 2020 - Mar 2021

  Clinical Data Manager 1
• 

  DOCS

  Mar 2021 - now

  Senior Global data manager