Clinical Trial Manager II. Barcelona or Madrid. FSP
hace 5 días
Barcelona
Experteer Overview In this role you will oversee site management, monitoring, and risk-based delivery for clinical trials within the Clinical Solutions team. You’ll coordinate cross-functional activities to meet milestones, ensure patient safety, data integrity, and regulatory compliance, and manage risk through proactive planning. The position involves collaboration with investigators, CRAs, and senior stakeholders to drive study performance and quality. This is an opportunity to contribute to drug development programs in a fast-paced, globally oriented environment. Compensaciones / Beneficios • Oversee site management, clinical monitoring, and central monitoring deliverables with emphasis on patient safety and regulatory compliance • Manage site interactions from activation to closeout, including recruitment and investigator payments • Identify data/process risks (e.g., via RACT) and implement mitigations • Review study scope, budget, and protocol content to align the clinical team with contractual obligations • Use operational data and metrics to identify risks to deliverables and escalate as needed • Lead and participate in key meetings (e.g., Kick Off) and coordinate with functional leaders for handoffs • Develop and maintain study tools and CTMS/dashboard setups, including UAT and audit trails • Coordinate training for study teams on protocols, CRFs, dashboards, SOPs, and data plans • Oversee resource allocations for CRAs and Central Monitors and monitor study team conduct • Ensure quality of deliverables and visibility of progress through tracking tools and dashboards • Review monitoring documentation to ensure accurate representation of site activities and risks • Maintain client communications with status updates and risk management proposals • Support inspection readiness and compliance with SOPs, ICH-GCP, and country regulations • Mentor and provide performance feedback to line managers; participate in larger, complex trials • May be assigned to more complex trials as needed Responsabilidades • Bachelor's degree or RN in a related field or equivalent • Proven ability to lead and align teams to achieve milestones • Experience working in an international environment • Expertise in site management and monitoring (clinical or central) • Knowledge of risk-based monitoring (preferred) • Understanding of clinical trial management financial principles and budgets • Knowledge of GCP/ICH guidelines and regulatory requirements • Strong computer and data management skills • Excellent communication, presentation, and interpersonal skills • Strong conflict resolution and problem-solving abilities • Ability to travel ~20% Requisitos principales • career development • training programs (technical and therapeutic) • supportive line management • peer recognition • total rewards program • inclusive culture
Laia J.Activo hace 10 horas