MS in Clinical Affairs

• Employ the global regulations, standards, and GCPs involved in designing, implementing and managing clinical trials for biologics, medical devices, and drugs.
• Apply knowledge of human rights obligations, the clinical life cycle, and adverse events to the design of a clinical trial.
• Select and utilize standard biomedical clinical affairs operating policies, procedures, forms, templates, reports, and electronic records.
• Design a methodology for a clinical trial with supportive data management and data analysis.
• Write compliance documents for clinical trials.
• Conduct a clinical trial regulatory audit/inspection.