Establishing a Clinical Operations team focused on achieving operational excellence

The Clinical Operations department needed to enhance efficiency across various critical areas, including patient recruitment, clinical trial data management, resource utilization, and performance tracking. There was a pressing need to implement a structured approach to manage resources effectively, ensure compliance, and reduce operational costs.

I implemented a comprehensive collaboration model that improved resource utilization and reduced costs for clinical studies by promoting better communication and cooperation between teams and sites. Additionally, I designed a capacity planning model to accurately forecast resource demand, enhancing decision-making related to country selection and resource allocation. To ensure high standards and efficient trial execution, I also established standard KPIs for clinical trials, improving performance tracking and regulatory compliance. Other key actions included optimizing patient recruitment processes, improving clinical trial data disclosure systems, establishing document quality control measures, ensuring inspection readiness, and developing SOPs and training programs.

The collaboration model led to a reduction in operational costs for clinical studies and improved resource utilization.

The capacity planning model provided accurate demand forecasting, resulting in optimized country selection and resource allocation. The introduction of KPIs enhanced performance tracking, supporting efficient trial execution and ensuring adherence to regulatory standards.

24 months

The project was executed with internal resources