RegulatoryandStartUpManager,SponsorDedicated

**Job Overview** Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. **Essential Functions** • Manages staff's delivery of site activation activities in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems. • Participate in the selection process for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained. • Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable. • Participate, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training. • Manage the quality of assigned staff's work through regular review and evaluation of work product. • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff. • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management. • Responsible for leading moderate improvements of processes, systems or products to enhance performance of the job area. • Problems faced are difficult, and may require understanding of broader set of issues. • Understands and demonstrates management approaches such as work scheduling, prioritizing , coaching and process execution. • Good knowledge and ability to apply GCP/ICH and applicable regulatory guidelines and applicable regulat