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.