Clinglobal

• Primary lead for scheduling and coordinating third-party qualification audits • Monitor and oversee CAPA (Corrective and Preventive Actions) progression and site deviations, ensuring timely resolution and effectiveness • Facilitate receipt, distribution, and tracking of Sponsor and/or Regulatory audit reports and responses • Serve as the primary QA liaison for review of global Standard Operating Procedures (SOPs) • Provide backup support for study-based audits across Clinglobal companies as required • Review of Computerized System validation and change management documents • Contribute to continuous improvement of QA processes and systems

• Oversee and actively engage in monitoring and clinical project management activities to ensure studies are conducted in adherence to scientific designs, timelines, and regulatory guidelines (e.g., VICH GL9 GCP) • Serve as the Sponsor's primary liaison, fostering effective communication and providing updates to the study team members and management • Responsible for providing strategic leadership and oversight in the planning, execution, and delivery of clinical projects • Plan, coordinate, and manage clinical projects to ensure delivery within timelines, budgets, and quality standards • Serve as a key point of contact for sponsors • Collaborate with cross-functional teams, including clinical monitoring, regulatory, and data management, to align project activities and objectives • Develop and maintain project documentation • Identify and address risks or challenges impacting project timelines, quality, or budgets, and implement corrective actions as needed • Coordinate human and material project resources and ensure availability to meet project milestones and deliverables • Collaborate with Regulatory Affairs, Quality Assurance, Finance, IT, and other Clinglobal group functions • Oversee and monitor the performance of project teams to ensure effective execution of assigned tasks • Ensure compliance with ethical standards, animal welfare regulations, and organizational policies throughout all project phases • Contribute to process improvement initiatives to enhance project efficiency and quality

• Oversee and actively engage in monitoring and clinical project management activities to ensure studies are conducted in adherence to scientific designs, timelines, and regulatory guidelines (e.g., VICH GL9 GCP) • Serve as the Sponsor's primary liaison, fostering effective communication and providing updates to the study team members and management • Responsible for providing strategic leadership and oversight in the planning, execution, and delivery of clinical projects • Plan, coordinate, and manage clinical projects to ensure delivery within timelines, budgets, and quality standards while adhering to regulatory guidelines • Collaborate with cross-functional teams to align project activities and objectives • Develop and maintain project documentation • Identify and address risks or challenges impacting project timelines, quality, or budgets, and implement corrective actions as needed • Coordinate human and material project resources and ensure availability to meet project milestones and deliverables

• Primary lead for scheduling and coordinating third-party qualification audits. • Monitor and oversee CAPA (Corrective and Preventive Actions) progression and site deviations, ensuring timely resolution and effectiveness. • Facilitate receipt, distribution, and tracking of Sponsor and/or Regulatory audit reports and responses. • Serve as the primary QA liaison for review of global Standard Operating Procedures (SOPs). • Provide backup support for study-based audits across Clinglobal companies as required. • Review of Computerized System validation and change management documents. • Contribute to continuous improvement of QA processes and systems.