Clinical Study Manager

Clinical Study Manager - Sponsor Dedicated - Spain, UK, Romania, Bulgaria, Czech Republic - remote

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.

You will contribute to the advancement of innovative treatments by ensuring biosample-related activities are executed in compliance with protocol requirements, study objectives, and regulatory standards.

What You Will Do

Your focus will be on coordinating clinical trial delivery, overseeing biosample management activities, resolving issues, and driving operational excellence across studies.

Key responsibilities includ:

• 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.
• Collaborate with cross-functional teams, including investigators, laboratories, vendors, biomarker teams, and internal stakeholders, to support successful study execution.
• 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.
• Lead the resolution of biosample- and study-related issues, including sample deviations, shipment delays, temperature excursions, and laboratory queries.
• 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.

Your Profile

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.

Required qualifications and experience:

• 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.
• Experience working with central laboratories, specialty laboratories, and/or laboratory vendors.
• Knowledge of laboratory manuals, sample management plans, sample traceability, and chain-of-custody processes.
• Experience identifying, managing, and resolving biosample- and laboratory-related risks and issues.
• Strong project management skills, including the ability to manage multiple priorities and stakeholders simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Detail-oriented with a focus on quality, compliance, and operational excellence.
• Experience supporting biomarker, PK/PD, genomic, translational, or other biospecimen programs is desirable.

What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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