18 oct
|
Icon Clinical
|
Madrid
18 oct
Icon Clinical
Madrid
Experteer Overview
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As a Clinical Study Manager with a sponsor-dedicated focus, you will oversee biosample management and laboratory operations across studies, collaborating with cross-functional teams to ensure regulatory compliance and study objectives. You will drive operational excellence, manage central laboratories and vendors, and monitor sample traceability and data quality. This role supports the development of treatments by enabling robust biospecimen programs within a integral drug development context. You’ll work in a collaborative environment that emphasizes patient impact and process improvement.
Compensaciones / Beneficios
• Oversee planning, execution, and monitoring of clinical studies to meet regulatory, objective, and timeline targets
• Lead oversight of biosample management: collection, processing, storage, shipment, tracking, reconciliation per protocol
• Collaborate with investigators, laboratories, vendors, biomarker teams,
and internal stakeholders to enable study execution
• Manage central laboratory and specialty vendor activities: oversight, issue escalation, performance monitoring, risk mitigation
• Review and support development of laboratory manuals, sample management plans, and lab procedures
• Monitor sample traceability, chain-of-custody, and quality metrics throughout the study lifecycle
• Develop and manage study budgets, resources, and timelines
• Lead resolution of biosample- and study-related issues (deviations, shipment delays, temperature excursions, lab queries)
• Ensure data integrity and quality through oversight and compliance across activities
• Support laboratory and biosample-related training for study teams and sites
Responsabilidades
• Bachelor’s degree in a scientific discipline or healthcare-related field
• Proven clinical study management experience with drug development and regulato
📌 Clinical Study Manager (Madrid)
🏢 Icon Clinical
📍 Madrid