Clinical Research Operations Management
Overview
Success in the biopharmaceutical industry requires significant clinical operations management skills. The clinical operations team is responsible for performance standards, quality, resource and budget planning, training and development. This course introduces participants to the roles and responsibilities that clinical operations managers and directors should be familiar with when establishing a clinical operations role in a company. The program will include hands-on exercises and case studies that incorporate the concepts taught so that participants may apply new skills back on the job.
Who will benefit
Candidates for this course include individuals new to a role in clinical operations or individuals with some experiences in clinical operations who want to improve their organization's support of the clinical development process such as clinical research associates, clinical operations managers/directors/VPs and executives considering reorganizing to incorporate the clinical operations model.
Key topics
- Roles an responsibilities
- Resource allocation and management
- Key performance indicators
- Outsourcing strategies and establishing vendor management capabilities
- Financial consolidation and budgetary planning
- Creation or improvement of the quality management system: Standard Operating Protocol (SOP) and processes
- Training and development of the clinical development organization
- Technical initiatives to support clinical development
Learning outcomes
- Understanding of roles and responsibilities of a clinical operations management position
- Knowledge of the competencies for a successful clinical operations manager/director
- Ability to design a clinical operations plan for a growing clinical department
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