Senior Clinical Data Manager

4 weeks ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Senior Clinical Data Manager

Everest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Data Manager to join our team. As a Senior 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 training on electronic data capture (EDC) system, dataflow, and quality control processes to clinical trial personnel.
  • Assist in performing client relationship management activities, including participating in project bid defense meetings.
  • Perform hands-on data management activities, including designing and reviewing case report forms (CRFs/eCRFs), developing and reviewing Case Report Form Completion Instructions, and generating and reviewing annotated Case Report Forms.
Qualifications and Experience:
  • 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 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.

Everest Clinical Research Services Inc is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

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