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Scientific. Clinical. Software Engineering

Senior Clinical Data Manager-Project Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -022020-26393 Region: New Jersey All

Job Description

  • Assume ownership and leadership for all Clinical Data Management owned deliverables
  • Serve as the key subject matter expert on topics related to data management activities
  • Vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups, presenting best practice at internal and external industry meetings/congress, and participating in due diligence assessment
  • Govern use of key data management element across studies in assigned projects
  • Contribute to data structure standards
  • Accountable or a contributor for CDM deliverables on study and/or project level
  • Ensure adequate application of Data Management Best Practices across studies within assigned projects
  • Review Study Team documents for project consistency and ensure the adequate documentation of all data management activities according to SOP
  • Provide governance and oversight for outsourcing activities by providing input on budgetary items
  • Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP)
  • Ensure CDM input and contribution to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
  • Proactive DM specific project planning and tracking (timelines, budget, risk assessment) of assigned projects
  • Establish data management best practice for data generated in research activities
  • Engage actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up
  • Share data arrival and cleanup status and metrics with the Study Team while Implementing Strategy
  • Support the development and implementation of strategic initiatives and activities

Requirements:

  • Bachelor s Degree
  • 8-10+ years of Clinical Data Management experience
  • Lead and Project Management (DM) experience is required


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