Clinical Data Management Lead

5 days ago


Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Summary

We are seeking a highly skilled and experienced Senior Clinical Data Manager to join our team at Everest Clinical Research Services Inc. 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, documenting deviations and issues, and following up on resolutions.
  • Lead day-to-day data management activities, responsible for all data management deliverables for assigned projects.
  • Communicate with clients on data management timelines and deliverables, request out-of-scope tasks, and resolve technical or procedural issues.
  • Plan and implement data management timelines and deliverables, provide database and data management activities status reports, and contribute to project planning, progress tracking, and reporting.
  • Assist with study-level resource planning and management, review team members' timesheet reports, and participate in project bid defense meetings.
  • Perform training on electronic data capture 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 reviews, and assist in generating project Work Orders and Amendments.
  • Manage dataflow from and performance of Third-Party Vendors, participate in project kick-off meetings, investigators meetings, and regular project management team meetings.
  • Provide support to client audits and regulatory inspections, follow up on audit findings, and 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 levels 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.
  • Strong leadership in clinical data management activities and a desire to excel in leading data management projects.


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