Clinical Study Manager - Biosamples (Remote)

About the role

ICON Strategic Solutions is hiring a Clinical Study Manager in a sponsor-dedicated model, working remotely for a single sponsor across Spain, the UK, Romania, Bulgaria and the Czech Republic. As a Biosamples Study Manager, you will oversee biosample management activities, laboratory operations and vendor partnerships so that clinical studies are delivered in line with protocol requirements, study objectives and regulatory standards.

Key responsibilities

• Oversee the planning, execution and monitoring of clinical studies to meet regulatory requirements, study objectives and project timelines.
• Lead biosample management: collection, processing, storage, shipment, tracking and reconciliation of samples.
• Manage central laboratory and specialty vendor activities, including issue escalation, performance monitoring and risk mitigation.
• Review and support laboratory manuals, sample management plans and study-specific laboratory procedures.
• Monitor sample traceability, chain-of-custody and sample quality metrics.
• Develop and manage study budgets, resources and timelines.
• Resolve biosample and study issues such as sample deviations, shipment delays, temperature excursions and laboratory queries.
• Ensure data integrity and quality, and support training and guidance for study teams and sites.

Required profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Proven clinical study management experience with knowledge of the drug development process and regulatory requirements.
• Experience supporting biosample management and working with central or specialty laboratories and laboratory vendors.
• Knowledge of laboratory manuals, sample management plans, traceability and chain-of-custody processes.
• Experience managing biosample and laboratory risks and issues.
• Desirable: experience with biomarker, PK/PD, genomic, translational or other biospecimen programs.

Required skills

• Strong project management skills, handling multiple priorities and stakeholders.
• Excellent communication and collaboration skills with cross-functional teams and external partners.
• Detail-oriented, focused on quality, compliance and operational excellence.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.