Job Description
General Description:
The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture.
Essential Functions of the Job:
+ •Team Resource Allocation & Performance
+ Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables.
+ Ensure CRAs have the required level of monitoring knowledge and skills to successfully perform required activities with high quality to meet study deliverables.
+ Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH-GCP, SOPs and local regulations.
The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture.
Essential Functions of the Job:
+ •Team Resource Allocation & Performance
+ Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables.
+ Ensure CRAs have the required level of monitoring knowledge and skills to successfully perform required activities with high quality to meet study deliverables.
+ Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH-GCP, SOPs and local regulations.