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Clinical Data Management Coordinator

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Job Opportunity

  • Project coordination and document management are key responsibilities for this role. Document tracking, control, and review activities will be performed on a project-by-project basis.
  • The coordinator is responsible for reviewing CRFs (as per protocol) and project-specific documents to ensure accuracy and compliance.
  • This role involves the creation, review, and maintenance of DMTMFs (Data Management Trial Master File) and e-filing, with ongoing monitoring and review required.
  • Preparation and coordination of project-specific documents are critical tasks in this position.
  • This role requires effective communication and issue resolution with clients and team members, in collaboration with Project Managers.
  • Database design and configuration, including user acceptance testing (UAT), are essential responsibilities in this role.
  • Procedure verification is necessary to ensure database validation and data integrity.
  • Data clarification forms must be created, reviewed, processed, and tracked to ensure data validity according to the protocol.
  • Manual data listings may be required from time to time.
  • This role involves supporting the maintenance of documents for pre-production and pre-lock audits.
  • Training for subordinates on project-specific processes is a key responsibility in this position.
  • Data managers may require backup support from time to time.
  • This role involves contributing to the development and review of departmental SOPs.
  • Basics QC functions are necessary for departmental activities.
  • Ensuring project deliverables comply with relevant regulations, guidelines, and procedures is crucial in this role.