• Acts as the primary point of contact on multiple global projects, ensuring contract, procedure and budget compliance through effective communication with project managers, internal teams, cross-functional groups and clients (as applicable). • Manages day-to-day department operations, both locally and globally, and exercises independent judgement to troubleshoot and resolve project issues and identity areas for improvement. Provides direct supervision to department managers and their teams as needed. • Provides accurate forecasts for all projects, analyzing safety management costs, personnel hours, and project needs to ensure budget compliance. • Manages and coordinates project start-up activities, project maintenance and project close-out. • Oversees the department's Incoming Information Center and associated vendors, including but not limited to the management of procedural and contractual adherence as well as troubleshooting and issue resolution. • Acts as a resource to other departmental managers for all safety administration tasks and collaborates to problem solve and develop system improvements; ensuring utilization of assigned administration team. • Leads departmental initiatives and develops WPDs and SOPs, ensuring consistency and quality in execution and implementation. • Coordinates business continuity activities as required in the event of system downtime, adverse weather or disaster. • Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records.

• Acts as the primary point of contact on multiple global projects, ensuring contract, procedure and budget compliance through effective communication with project managers, internal teams, cross-functional groups and clients (as applicable) • Manages day-to-day department operations, both locally and globally, and exercises independent judgement to troubleshoot and resolve project issues and identity areas for improvement • Provides direct supervision to department managers and their teams as needed • Provides accurate forecasts for all projects, analyzing safety management costs, personnel hours, and project needs to ensure budget compliance • Manages and coordinates project start-up activities, project maintenance and project close-out • Oversees the department's Incoming Information Center and associated vendors, including but not limited to the management of procedural and contractual adherence as well as troubleshooting and issue resolution • Acts as a resource to other departmental managers for all safety administration tasks and collaborates to problem solve and develop system improvements; ensuring utilization of assigned administration team • Leads departmental initiatives and develops WPDs and SOPs, ensuring consistency and quality in execution and implementation • Coordinates business continuity activities as required in the event of system downtime, adverse weather or disaster • Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations • Approves courses of action on salary administration, hiring, corrective action, and terminations • Reviews and approves time records

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics. • Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. • Ensure timely archiving of documents and study materials for the department. • May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • Coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions are addressed.

• Serve as an effective communication “bridge” between sites, third party vendors and the sponsor • Building and maintaining strong relationships with key stakeholders at clinical trial sites • Monitoring site performance metrics and providing regular updates to study teams on site engagement activities and outcomes • Collaborating with internal teams to develop and implement site engagement strategies tailored to the specific needs of each study and site • Identifying opportunities to improve site engagement and optimize site performance through regular communication and feedback mechanisms • Providing support and guidance to site staff on study protocols, procedures, and regulatory requirements