Biosampling Project Manager

ICON Clinical Research; City of Rome (NY); Hybrid; USD 38,000 - 50,000; Full time

Benefits offered by this job

Health insurance

Leave entitlements

Retirement planning

Global Employee Assistance Programme

Life assurance

Job summary

ICON Strategic Solutions is seeking a Biosampling Project Manager / Central Laboratory Study Manager to lead and coordinate human biological samples (HBS) across global clinical studies in a remote Romania setting.

You will act as the liaison between study teams, central laboratory partners and cross-functional stakeholders to ensure seamless management of samples throughout the trial lifecycle.

Qualifications

• Master’s degree in Life Sciences or related field.
• Minimum 5 years of experience in clinical laboratory operations and trial conduct.
• Strong understanding of central laboratory operations in clinical research.

Responsibilities

• Lead and coordinate central laboratory activities across global clinical studies.
• Act as the primary liaison between study teams and central laboratory partners.
• Develop and maintain Human Biological Sample Management (HBSM) Plans and Sample Risk Assessments.
• Ensure sample flow, testing activities, and data delivery processes are established and maintained.
• Oversee sample chain of custody, lab operations, and issue resolution across global networks.
• Manage laboratory budgets, forecasts, and performance reporting.
• Collaborate withClinical Operations, Data Management, Laboratory Vendors, and other teams.
• Drive continuous improvement of laboratory and sample management processes.

Job description

Biosampling Project Manager / Central Laboratory Study Manager - Remote - Romania

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.

In this role you will lead and coordinate central laboratory activities across global clinical studies. In this pivotal role, you will act as the key link between clinical study teams, central laboratory partners, and cross-functional stakeholders, ensuring the seamless management of human biological samples (HBS) throughout the clinical trial lifecycle.

What You Will Do:

You will be responsible for the operational setup, oversight, and management of central laboratory activities for clinical studies.

Your key responsibilities will include:

• Serving as the primary point of contact between study teams and central laboratory partners.

• Coordinating the management of human biological samples from study start-up through study close-out.

• Developing and maintaining Human Biological Sample Management (HBSM) Plans and Sample Risk Assessments.

• Ensuring appropriate sample flow, testing activities, and laboratory data delivery processes are established and maintained.

• Overseeing sample chain of custody, laboratory operations, and issue resolution across global laboratory networks.

• Managing laboratory budgets, forecasts, and performance reporting.

• Collaborating closely with Clinical Operations, Data Management, Laboratory Vendors, Human Genetics, and other cross-functional teams.

• Acting as a subject matter expert and driving continuous improvement of laboratory and sample management processes.

Your Profile:

• Master’s degree in Life Sciences, Medical Sciences, or a related discipline.

• Minimum 5 years of experience in clinical laboratory operations and clinical trial conduct.

• Strong understanding of central laboratory operations within clinical research development.

• Excellent knowledge of ICH-GCP and GCLP requirements.

• Demonstrated project management capability in complex, cross-functional environments.

• Excellent written and verbal communication skills in English.

• Proven track record in project planning, execution, and issue resolution.

• Experience managing laboratory vendors and external partners.

• Strong experience working within global, matrixed, and multicultural organizations.

• Experience leading operational meetings and coordinating multiple stakeholders.

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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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)