Clinical Study Manager (Madrid)

Clinical Study Manager (Madrid)

17 oct
|
Icon Clinical
|
Madrid

17 oct

Icon Clinical

Madrid

Experteer Overview 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 global 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 regulatory knowledge• Experience supporting biosample management activities (collection, processing, storage, shipment, tracking, reconciliation)• Experience working with central/specialty laboratories and laboratory vendors• Knowledge of laboratory manuals, sample management plans, traceability, and chain-of-custody• Experience identifying and resolving biosample- and lab-related risks and issues• Strong project management skills for handling multiple priorities and stakeholders• Excellent communication and collaboration with cross-functional teams and external partners• Detail-oriented with focus on quality, compliance, and operational excellence• Desirable experience with biomarker, PK/PD, genomic, translational, or biospecimen programs

Requisitos principales• Annual leave entitlements• Health insurance offerings• Retirement planning options• Integral Employee Assistance Programme (Life

Works)• Life assurance• Flexible country-specific benefits

📌 Clinical Study Manager (Madrid)
🏢 Icon Clinical
📍 Madrid

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