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At DROX we are looking for enthusiastic people
who can direct and coordinate with passion.
Country Study Manager
Objective: Perform the planning and supervision of the management activities of a clinical study, from the study initiation stage, conduct and closure of the study according to the guidelines of the ICH/GCP good clinical practices and applicable regulations.
Responsibilities:
- Primary contact with the clinical trial sponsor regarding operational and deliverable aspects of the project.
- To be fully familiar with the protocol, therapeutic area and indication of the clinical study.
- Monitor project stakeholders internally to identify the status of each deliverable.
- Supervise and coordinate the training required for those involved in conducting the study.
- Review and provide feedback on reports generated during all stages of the study.
- To carry out the planning of the activities of all the stages of the study.
- Perform project risk analysis and establish actions.
- Management and monitoring of the activities of external suppliers necessary for the conduct of the project.
- Supervise the performance of the research centers.
- Develop clinical study monitoring plans.
- Evaluate the performance of the Clinical Monitors assigned to the study.
- Distribute activities to the clinical monitors assigned to the study.
- Follow up on the activities carried out by the regulatory affairs specialist.
- Coordinate and supervise feasibility visits and research site selection activities.
- Coordinate and supervise clinical study monitoring activities.
- Coordinate site activation and closure activities.
Send us an email with your resume to