ICON Strategic Solutions
Central Monitor
ICON plc is a world‑leading healthcare intelligence and clinical research organization. We foster an inclusive environment, driving innovation and excellence, and welcome you to join us on our mission to shape the future of clinical development.
Job title – Central Monitor Location – Bulgaria, Poland, UK, Belgium (remote) Fully sponsor dedicated Working fully embedded within a growing program at ICON, you will play a key role in overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk‑based monitoring strategies.
What you will be doing: Central Monitoring Execution:
Implement and execute centralized monitoring strategies to support clinical trial oversight.
Conduct ongoing central monitoring analysis of clinical trial data to detect trends and signals.
Work with the Data Analysts team in reviewing Central Monitoring technology outputs and performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with study teams.
Risk Identification and Management:
Perform risk assessments based on data review, identifying potential site or trial risks.
Collaborate with Lead Central Monitor and study teams to refine and implement risk‑based monitoring plans.
Provide insights and recommendations to enhance trial efficiency and mitigate risks.
Data Review and Reporting:
Generate and summarize findings (Central Monitoring reports and dashboards) and lead the communication of results to study teams (both written report and oral presentation). Contribute to GCO understanding of the impact of findings on data quality.
Support DQT in assessing the criticality and potential root causes of the findings and in defining appropriate follow‑up actions.
Support study teams in adopting an approach to clinical trial monitoring that utilizes data and site‑level information to determine needs for performing on‑site, remote and centralized monitoring activities and focuses resources on risks that have the most potential to impact patients’ safety and data quality.
Collaboration and Cross‑Functional Engagement:
Collaborate with cross‑functional study teams, including Risk Surveillance Leads, Study Leaders, Data Managers, and Clinical Scientific Leaders, to ensure robust risk mitigation plans are in place and effectively executed.
Participate in study team meetings and provide data‑driven recommendations.
Act as a single point of contact for Central Monitoring activities for relevant stakeholders for allocated studies and ensure timely communication and coordination.
Protocol and Study Design Support:
Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of Central Monitoring efforts.
Continuous Improvement and Compliance:
Support the continuous improvement of centralized monitoring methodologies.
Ensure adherence to regulatory requirements, SOPs, and Good Clinical Practice (GCP) guidelines.
You are:
University degree in life science, business or operations.
Fluent in both written and spoken English.
≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs.
Must have experience with CluePoints.
Must have exposure to central monitoring, ideally with hands‑on experience in Data Quality Analysis/unsupervised centralized statistical monitoring.
Ideally you have contributed to the development of central monitoring strategies based on IqRMPs, or had direct experience in developing an IqRMP or RACT.
Strong clinical experience with excellent understanding of clinical trial development and risk management processes.
Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance, and the risk management process.
Experience in CluePoints is preferred.
Proven hands‑on experience in Data Quality Analysis, including methodologies often referred to by sponsors as unsupervised centralized statistical monitoring.
Demonstrated involvement in developing central monitoring strategies informed by Integrated Quality Risk Management Plans (IqRMPs).
Direct experience in authoring or contributing to the development of an IqRMP or Risk Assessment Categorization Tool (RACT).
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.
Various annual leave entitlements.
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximise 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 specialised professionals who support you and your family’s well‑being.
Life assurance.
Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
Inclusion & Belonging: 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 to perform the essential functions of a position, please let us know through the form below:
Reasonable Accommodations
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 for this or other roles.
Are you a current ICON Employee? Please click
here
to apply.
#J-18808-Ljbffr
ICON plc is a world‑leading healthcare intelligence and clinical research organization. We foster an inclusive environment, driving innovation and excellence, and welcome you to join us on our mission to shape the future of clinical development.
Job title – Central Monitor Location – Bulgaria, Poland, UK, Belgium (remote) Fully sponsor dedicated Working fully embedded within a growing program at ICON, you will play a key role in overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk‑based monitoring strategies.
What you will be doing: Central Monitoring Execution:
Implement and execute centralized monitoring strategies to support clinical trial oversight.
Conduct ongoing central monitoring analysis of clinical trial data to detect trends and signals.
Work with the Data Analysts team in reviewing Central Monitoring technology outputs and performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with study teams.
Risk Identification and Management:
Perform risk assessments based on data review, identifying potential site or trial risks.
Collaborate with Lead Central Monitor and study teams to refine and implement risk‑based monitoring plans.
Provide insights and recommendations to enhance trial efficiency and mitigate risks.
Data Review and Reporting:
Generate and summarize findings (Central Monitoring reports and dashboards) and lead the communication of results to study teams (both written report and oral presentation). Contribute to GCO understanding of the impact of findings on data quality.
Support DQT in assessing the criticality and potential root causes of the findings and in defining appropriate follow‑up actions.
Support study teams in adopting an approach to clinical trial monitoring that utilizes data and site‑level information to determine needs for performing on‑site, remote and centralized monitoring activities and focuses resources on risks that have the most potential to impact patients’ safety and data quality.
Collaboration and Cross‑Functional Engagement:
Collaborate with cross‑functional study teams, including Risk Surveillance Leads, Study Leaders, Data Managers, and Clinical Scientific Leaders, to ensure robust risk mitigation plans are in place and effectively executed.
Participate in study team meetings and provide data‑driven recommendations.
Act as a single point of contact for Central Monitoring activities for relevant stakeholders for allocated studies and ensure timely communication and coordination.
Protocol and Study Design Support:
Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of Central Monitoring efforts.
Continuous Improvement and Compliance:
Support the continuous improvement of centralized monitoring methodologies.
Ensure adherence to regulatory requirements, SOPs, and Good Clinical Practice (GCP) guidelines.
You are:
University degree in life science, business or operations.
Fluent in both written and spoken English.
≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs.
Must have experience with CluePoints.
Must have exposure to central monitoring, ideally with hands‑on experience in Data Quality Analysis/unsupervised centralized statistical monitoring.
Ideally you have contributed to the development of central monitoring strategies based on IqRMPs, or had direct experience in developing an IqRMP or RACT.
Strong clinical experience with excellent understanding of clinical trial development and risk management processes.
Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance, and the risk management process.
Experience in CluePoints is preferred.
Proven hands‑on experience in Data Quality Analysis, including methodologies often referred to by sponsors as unsupervised centralized statistical monitoring.
Demonstrated involvement in developing central monitoring strategies informed by Integrated Quality Risk Management Plans (IqRMPs).
Direct experience in authoring or contributing to the development of an IqRMP or Risk Assessment Categorization Tool (RACT).
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.
Various annual leave entitlements.
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximise 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 specialised professionals who support you and your family’s well‑being.
Life assurance.
Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
Inclusion & Belonging: 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 to perform the essential functions of a position, please let us know through the form below:
Reasonable Accommodations
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 for this or other roles.
Are you a current ICON Employee? Please click
here
to apply.
#J-18808-Ljbffr