Overview
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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 xqbhyrx
- 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 - españa
🏢 Jobrapido
📍 España