Descripción de la oferta
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.
ResponsabilidadesOversee the monitoring strategy for internal and sponsor teams and justify chosen approachesParticipate in proposal development and RBM strategy for Clinical OperationsSupport commercial activities such as Bid Defense, representing clinical operations and RBM componentsCollaborate with SSU to maintain start-up timelines and escalate delaysEvaluate and oversee the Risk Assessment and Categorization Tool (RACT) for quality and ICH complianceManage protocol execution risks and ensure closed-loop issue resolution in clinical deliveryCoordinate with internal and external vendors to operationalize monitoring strategies and central monitoringMaintain expert knowledge of industry trends and regulatory frameworks
Requisitos principalesBachelor’s degree in a related field12+ years of clinical research experience5+ years in Clinical Trial Manager, Clinical Lead, or Project Management rolesLine management experience preferredExpert knowledge of GCP and ICH E6 R2 and applicable regulationsExperience implementing Risk Based Monitoring methodologiesUnderstanding of all clinical operations phases from start-up to close-outExpertise with central monitoring approaches and toolsStrong financial management experience for projectsLeadership and people managementCross-functional collaborationEffective communication and stakeholder managementGCP and ICH E6 R2 expertiseRisk Based Monitoring methodologies and conceptsCentral monitoring systems and tools
