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Senior Clinical Data Manager

2 months ago

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

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled Senior Clinical Data Manager to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office in the USA.

Key Responsibilities:
  • Develop and maintain Data Management Project Plans, documenting deviations and issues, and ensuring timely resolutions.
  • Lead data management activities, including training and client relationship management, ensuring high-quality deliverables and customer satisfaction.
  • Design and review case report forms (CRFs/eCRFs), develop and review Case Report Form Completion Instructions, and generate and review annotated CRFs.
  • Develop and maintain data validation specifications, Data Management Plans, and Data Quality Review Plans, ensuring compliance with regulatory requirements and industry standards.
  • Manage database design, EDC User Acceptance Testing (UAT), and database modifications due to protocol amendments or study needs.
  • Perform Third Party non-CRF data management activities, review data, issue and resolve queries, and assist Investigative Site personnel with resolving queries.
  • Assist in resolving medical coding discrepancies and cooperate with the Quality Assurance Department on quality control audits.
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.