Experteer Overview As Senior Director, you will lead clinical strategy and delivery within the Clinical Management team to translate science into medicines, devices and diagnostics. You will shape risk-based monitoring and trial execution by collaborating with vendors, SSU and cross-functional teams to meet timelines and quality standards. You will drive regulatory-aligned operations, risk assessment processes and central monitoring capabilities at scale. This role offers impact across programs and a chance to influence how clinical delivery supports patient outcomes and innovation.Compensaciones / Ventajas - Participate in Proposal Development for Clinical Operations with a focus on risk-based monitoring (RBM) where appropriate - Support commercial activities such as Bid Defense meetings, representing clinical operations and RBM components - Collaborate with SSU to ensure start-up activities stay on schedule and escalate delays - Create and oversee the monitoring strategy for internal teams and sponsors with justification for chosen approach - Maintain expert knowledge of industry trends and regulatory frameworks - Evaluate the Risk Assessment and Categorization Tool (RACT) for quality, consistency,



and ICH compliance; participate in initial risk assessment and ongoing review meetings - Oversee clinical teams' management of protocol execution risks to ensure closed-loop issue resolution - Coordinate with internal and external technology vendors to implement feasible monitoring strategies for Central Monitoring activities - Demonstrate good understanding of all aspects of clinical operations delivery from start-up to close-out - Possess expertise with central monitoring approaches and systems and tools - Maintain strong understanding of financial management of projectsResponsabilidades - Bachelor's degree in a related field or equivalent - 12+ years clinical research experience - 5+ years in Clinical Trial Manager, Clinical Lead or Project Management; line management experience preferred - Expert knowledge of GCP and ICH E6 R2 and applicable regulatory requirements - Experience implementing RBM methodologies and concepts - Strong understanding of all clinical operations delivery phases - Expertise with central monitoring approaches and systems - Experience in financial management of projectsRequisitos principales -

📌 Senior Director, Clinical Strategy And Delivery (España)
🏢 Premier Research
📍 España