Clinical Study Manager

Location: Puerto Rico

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…