Clinical Operation – Manager

No of openings : 1

Experience : 3 to 5 yrs experience in Clinical Operations.

Job Description :

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


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