Risk Based Management for Project Managers

This course provides project managers in clinical research with the tools and knowledge to effectively implement risk-based management (RBM) principles throughout the lifecycle of clinical trials. In an increasingly complex regulatory environment, RBM has become a critical approach to ensure the safety of participants, maintain data quality, and manage operational efficiency. Participants will learn to identify, assess, and mitigate risks through proactive planning and decision-making processes. The course covers key concepts of risk identification, risk categorization, risk assessment, and the application of monitoring strategies aligned with regulatory guidelines such as ICH E6 (R2). Practical case studies and examples from real-world clinical trials will be used to illustrate risk management methodologies and their impact on trial success. This course is ideal for clinical research project managers, clinical trial leads, and professionals involved in the operational management of clinical trials who seek to enhance their expertise in risk management practices. It is also suitable for those preparing to transition into roles that require in-depth knowledge of RBM in clinical trials. Course Format: Duration: 2-3 days (online) Interactive, case studies, and scenarios Prerequisites: Basic understanding of clinical trial management principles and good clinical practice (GCP).