Overview
Desplácese hacia abajo para encontrar los detalles completos de la oferta de trabajo, incluyendo la experiencia requerida y las funciones y tareas asociadas.
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 xqbhyrx 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

📌 Senior Director, Clinical Strategy and Delivery (Santander)
🏢 Premier Research
📍 Santander