Senior Clinical Data Manager

4 weeks ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve some of the world's most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

We are seeking a highly skilled and experienced Clinical Data Manager to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office anywhere in the USA. As a Clinical Data Manager, you will be responsible for leading data management activities, performing training and client relationship management.

Key Responsibilities:

  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Lead data management activities, including planning and implementing data management timelines and deliverables.
  • Provide database and data management activities status reports, and contribute to the overall project planning, progress tracking and reporting.
  • Assist with study-level resource planning and management, including the review of team members' timesheet reports.
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
  • Provide training to new data management personnel on data management processes and procedures.
  • 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 meeting, investigators meeting, and regular project management team meeting.
  • Provide support to client audits and regulatory inspections. Follow up on audit findings.
  • Create and maintain clinical trial Data Management Study Binders.

Requirements:

  • A Bachelors' 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 year 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 an 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.

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