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

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