Senior Clinical Study Manager

Clinical Study Manager Maximice sus posibilidades de que su candidatura sea seleccionada asegurándose de que su CV y sus habilidades se ajustan al perfil.
Spain, UK, Romania, Bulgaria, Czech Republic
remoteAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As a Clinical Study Manager at ICON being assigned to a single sponsor as a Biosamples Study Manager, you will support the successful delivery of clinical studies through oversight of biosample management activities, laboratory operations, and vendor partnerships.
Your focus will be on coordinating clinical trial delivery, overseeing biosample management activities, resolving issues, and driving operational excellence across studies.
Oversee the planning, execution, and monitoring of clinical studies to ensure compliance with regulatory requirements, study objectives, and project timelines.
Lead oversight of biosample management activities, ensuring sample collection, processing, storage, shipment, tracking, and reconciliation activities are managed in accordance with protocol requirements and applicable regulations.
Manage central laboratory and specialty vendor activities, including operational oversight, issue escalation, performance monitoring, and risk mitigation.
Review and support the development of laboratory manuals, sample management plans, and study-specific laboratory procedures.
Monitor sample traceability, chain-of-custody processes, and sample quality metrics throughout the study lifecycle.
Develop and manage study budgets, resources, and timelines, ensuring efficient use of resources and adherence to study plans.
Ensure data integrity and quality through effective oversight, monitoring, and compliance processes across all study activities.
Support laboratory and biosample-related training and guidance for study teams and sites as required.
You will have solid clinical trial management experience combined with exposure to biosample management, laboratory operations, or central laboratory oversight within a clinical research environment. Bachelor's degree in a relevant scientific discipline or healthcare-related field.
Proven experience in clinical study management with a strong understanding of the drug development process and regulatory requirements.
Experience supporting biosample management activities within clinical trials, including oversight of sample collection, processing, storage, shipment, tracking, and reconciliation processes.
Knowledge of laboratory manuals, sample management plans, sample traceability, and chain-of-custody processes.
Strong project management skills, including the ability to manage multiple priorities and stakeholders simultaneously.
Detail-oriented with a focus on quality, compliance, and operational excellence.
LI-Remote#LI-SK1Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location. Czech Republic, Prague; UK, ReadingType: Full time