Senior Clinical Data Manager

3 days ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Senior Clinical Data Manager

Everest Clinical Research Services Inc is seeking a highly skilled Senior Clinical Data Manager to join our team in Bridgewater, New Jersey, USA. As a key member of our data management team, you will be responsible for leading data management activities, performing training, and client relationship management.

Key Responsibilities:
  • Develop and maintain Data Management Project Plans, document deviations, and log issues.
  • Lead data management activities, including planning, implementing, and providing database and data management activities status reports.
  • Assist with study-level resource planning and management, including reviewing team members' timesheet reports.
  • Perform training on electronic data capture (EDC) systems, dataflow, and quality control processes to clinical trial personnel.
  • Provide training to new data management personnel on data management processes and procedures.
  • Assist in generating project Work Orders and Amendments.
  • Manage dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
  • Participate in project kick off meetings, investigators meetings, and regular project management team meetings.
  • Provide support to client audits and regulatory inspections.
Requirements:
  • Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 years of experience as a Clinical Data Manager II.
  • Demonstrated in-depth understanding of clinical trial data management concepts, processes, and procedures.
  • Strong leadership skills and ability to excel in leading data management projects.

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