Global Certificate in Trial Operations Leadership Skills

• Trial Operations Management: This unit will cover the fundamental concepts and best practices for managing clinical trial operations, including site selection, budgeting, and project management.
• International Regulatory Affairs: This unit will focus on understanding the global regulatory landscape for clinical trials, including ICH-GCP guidelines and regional regulations in the US, Europe, and Asia.
• Clinical Data Management: This unit will cover the collection, management, and analysis of clinical trial data, including the use of electronic data capture (EDC) systems and data validation.
• Vendor Management: This unit will cover the process of selecting, managing, and evaluating vendors for clinical trial operations, including CROs, laboratories, and other service providers.
• Site Management: This unit will cover the best practices for managing clinical trial sites, including site initiation, monitoring, and close-out.
• Pharmacovigilance: This unit will focus on the safety monitoring and reporting processes for clinical trials, including adverse event reporting and signal detection.
• Quality Assurance and Quality Control: This unit will cover the principles and practices of quality assurance and quality control in clinical trial operations, including audits and inspections.
• Project Management for Clinical Trials: This unit will cover advanced project management concepts and tools for clinical trial operations, including risk management and stakeholder engagement.
• Clinical Trial Budgeting and Financial Management: This unit will cover the financial planning, budgeting, and cost management processes for clinical trial operations, including forecasting and cost tracking.