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Clinical Data Manager Location: Ottawa, Canada
Desription

Position Overview:

The Clinical Data Manager will be responsible for the development, validation and maintenance of Clinical systems used to collect and archive Clinical Data and Records.

Job Description

  • Design and maintain electronic clinical research management databases. Experience in IBM Clinical Development or equivalent clinical electronic data capture systems is highly desirable.
  • Maintenance of data management documentation and archiving clinical trial data and study documentation.
  • Design of case report forms and database validation checks based on an understanding of the therapeutic area of interest.
  • Validation of electronically captured data, querying both missing data and data points failing range checks and/or logical checks.
  • Design and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activities.
  • Training of sites and supporting study team members on data management activities at two investigator meetings.
  • Direct communication with site personnel to assist in resolution of queries.
  • Design and Maintain Clinical SharePoint Sites.
  • Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
  • Other miscellaneous duties as may be required.

Required Education and Experience

  • Undergraduate university Degree (4 year program), or equivalent experience (e.g. B.Sc., B. Eng)
  • Requires a minimum of 6 รข?? 10 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Clinical Research Data Management or equivalent.
  • Member of Society for Clinical Data Management (CCDM Certification preferred)
  • International Harmonized /Committee Good Clinical Practices, IHC/GCP.
  • Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems.
  • Implementation of Electronic Data Capture for Clinical Studies.
  • Implementation of Clinical Trial Management Systems for Clinical Studies
  • Knowledge of project management tools and techniques.
  • Broad knowledge and application of business concepts, procedures and practices.
  • Intermediate working knowledge of MS Office.
  • Programming experience in any of the following: SAS, SAS JMP, R, Python.
  • Excellent Communications skills, both oral and written.
  • Ability to initiate, plan and manage projects.
  • Strong decision-making skills and ability to prioritize.
  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.