Senior Director, Clinical Strategy and Delivery
20 hours ago
Tarragona
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