Senior Director, Clinical Strategy and Delivery
hace 1 día
Zaragoza
Overview In this role you lead clinical strategy and delivery within Clinical Management to transform science into medicines, devices, and diagnostics. You partner with cross-functional teams and external vendors to optimize monitoring, risk-based approaches, and start-up execution, ensuring timely delivery and regulatory compliance. You influence proposal development and business growth while upholding patient-centric outcomes. This leadership position shapes how clinical operations scale and streamline with a strong focus on risk management and governance. Responsabilidades • Oversee the monitoring strategy for internal and sponsor teams and justify chosen approaches, • Participate in proposal development and RBM strategy for Clinical Operations, • Support commercial activities such as Bid Defense, representing clinical operations and RBM components, • Collaborate with SSU to maintain start-up timelines and escalate delays, • Evaluate and oversee the Risk Assessment and Categorization Tool (RACT) for quality and ICH compliance, • Manage protocol execution risks and ensure closed-loop issue resolution in clinical delivery, • Coordinate with internal and external vendors to operationalize monitoring strategies and central monitoring, • Maintain expert knowledge of industry trends and regulatory frameworks Requisitos principales • Bachelor’s degree in a related field, • 12+ years of clinical research experience, • 5+ years in Clinical Trial Manager, Clinical Lead, or Project Management roles, • Line management experience preferred, • Expert knowledge of GCP and ICH E6 R2 and applicable regulations, • Experience implementing Risk Based Monitoring methodologies, • Understanding of all clinical operations phases from start-up to close-out, • Expertise with central monitoring approaches and tools, • Strong financial management experience for projects, • Leadership and people management, • Cross-functional collaboration, • Effective communication and stakeholder management, • GCP and ICH E6 R2 expertise, • Risk Based Monitoring methodologies and concepts, • Central monitoring systems and tools
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