Senior Clinical Data Manager

2 days ago


Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
About the Role

We are seeking a highly skilled and experienced Clinical Data Manager to join our team at Everest Clinical Research Services Inc. as a Senior Clinical Data Manager. This is a key role that 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 and report issues.
  • Lead data management activities, including planning and implementing data management timelines and deliverables.
  • Provide database and data management activities status reports, and contribute to overall project planning, progress tracking, and reporting.
  • Assist with study-level resource planning and management, including review of 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.
  • Perform QC review of work performed by less experienced data management personnel.
  • Assist in generation of project Work Orders and Amendments.
  • Assist in management of 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, and follow up on audit findings.
  • Create and maintain clinical trial Data Management Study Binders.
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, with demonstrated knowledge, experience, and ability to perform to meet high quality standards and high level of customer satisfaction.
  • Demonstrated in-depth understanding of clinical trial data management concepts, processes, and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
  • Demonstrated strong leadership in clinical data management activities and a desire to excel in leading data management projects.


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