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Laboratory Study Manager

Role overview

Qualifications

  • 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

Responsibilities

  • 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

Key facts

Other skills

  • Communication
  • Collaboration
  • Problem Solving

About the company

ICON plc logo

ICON plc

Contract Research Organizations (CRO)

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Study Manager (Central Labs)/ Biosampling Project Manager /Laboratory Study Manager - Remote

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


As a Clinical Study Manager at ICON, 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.

#LI-DS1

#LI-Remote


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • 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 wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


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


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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Marcus Rivera

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