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operations

Posted 2 hours ago

Clinical Operations Lead (Clinical Trial Manager) (India)

at Alimentiv

Delhi, IndiaOn-site

Responsibilities

  • responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.

Additional details

  • Responsible for the clinical operations of a project within a defined regional/global level.
  • Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.
  • The COL acts as a primary liaison between the CRAs and the clinical project team. Additional
  • The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

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