Clinical Operation-Manager

Posted 2 months ago

No of openings: 1

Experience : 3 to 5 yrs experience in Clinical Operations.

Job Description :

  • Training the teams and new employees regularly and periodically.
  • Negotiating the study budgets with the Principal Investigator and executing the Clinical Trial Agreement.
  • Assigning and Managing the project team as per the study requirement.
  • Development and Revision of departmental SOPs.
  • Reviews CRA Site Visit documents (follow up letters and reports).
  • Reviews and Approves the travelling plan and budgets of the monitors.
  • Updating the sponsor about the progress of the study as agreed in the contract.
  • Participating in telecoms with the clients and kick of meetings.
  • Hosting the external audits.
  • Preparing Monitoring plan for the CRA as per the study specifications and protocol and training the CRA on the same.
  • Training the team on study related documents.
  • Managing and coordinating all regional CRA activities.
  • To perform co-monitoring visits to ensure quality of data generated
  • If required accompanying the CRA’s in Qualification visit, Site Initiation Visit and Monitoring visits.
  • Organize and present at Investigator Meetings/ Internal meetings.
  • Development of project management plan, risk management plans.
  • Review the Ethics Committee dossiers as required.
  • Review of power point presentations prepared by CRA for investigator meetings, Site Initiation visits.

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