Global Certificate in Trial Operations Performance
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⢠Trial Operations Fundamentals: Understanding the basics of clinical trial operations, including study design, site selection, and project management.
⢠Regulatory Compliance: Ensuring adherence to global regulations and guidelines, including ICH-GCP, FDA, and EMA.
⢠Site Management: Managing relationships with investigator sites, including site initiation, training, and monitoring.
⢠Data Management: Collecting, cleaning, and managing clinical trial data, including eCRF design and implementation.
⢠Pharmacovigilance: Managing safety reporting and adverse event monitoring throughout the trial.
⢠Quality Management: Implementing and maintaining quality systems, including SOP development and CAPA management.
⢠Budgeting and Financial Management: Developing and managing study budgets, including sponsor and site financial agreements.
⢠Vendor Management: Selecting, managing, and monitoring vendors, including CROs and other service providers.
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