• 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. • Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation. • Quality and Compliance - Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices. • Support study/site milestone delivery in collaboration with cross-functional teams. • Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies. • Contribute to process optimization initiatives and manage risk escalation and resolution. • Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow-up for identified issues. • Expense Review and Management - Review and approve expenses related to CRA activities to ensure alignment with applicable policies and financially best local practices. • Identify opportunities for cost-saving and efficiency while maintaining quality and compliance standards.