Medical Monitor at Clintec

Job description

Clintec is actively recruiting for a Medical Monitor to join our expanding global company in South Africa. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description

The Medical Monitor will have responsibilities to ensure the safety of subjects participating in Clinical Trials. The Medical Monitor will be expected to take appropriate actions as are delegated to ensure the timely and quality performance of clinical trials, collection of data and completion of Study Reports for assigned projects.

Responsibilities Of The Medical Monitor

• Providing Medical Leadership to the monitoring staff in the region
• Developing and maintaining expertise in the compounds under development and their related fields
• Monitoring the safety of subjects participating in the Clinical Trials
• Selection of Clinical Investigators
• Handling Serious Adverse Event Reports in accordance with the SOPs
• Ensuring timely distribution of IND reports to investigators and EC
• Review and agreement of study budgets with the sites
• Review of the site monitoring reports for safety
• Supporting the CRAs in ensuring that sites conform to GCP and SOPs
• Participating in internal study team meetings
• To participate in the training of the department staff

Essential Criteria

• Practical experience as a Physician within a hospital environment
• Medical Doctor Degree
• Clinical Trials monitoring experience
• Knowledge of Clinical Trial Regulations in the countries of the Region
• Knowledge of Clinical Trial methodology and design
• Thorough understanding of the protocol, ICH-GCP, ICF and SOPs
• Excellent communication skills and the ability to work both independently and in the team
• Fluency in English (both written and spoken)
• Good computer skills