Job Information
ICON Clinical Research Central Monitor in Remote, Serbia
Central Monitor
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Job title - Central Monitor
Location - Romania, Serbia and South Africa (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.
Role Accountabilities
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 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.
Interpret the study protocol to define key data for analysis; support Data Analysts in defining key data.
Ensure adherence to risk-based monitoring plans, SOPs, and industry best practices.
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.
Support root cause analysis for identified issues and suggest corrective actions.
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 impact of findings to data quality.
Support DQT in assessing the criticality and potential root causes of the findings and in defining appropriate follow-up actions
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
Client role requirements:
≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs. Strong clinical experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials. Specific central monitoring / monitoring experience are strongly preferred.
Ideally, you'll have demonstrable experience working with Cluepoints.
≥ 3 years comprehensive experience in monitoring (central), clinical data analytics, data management activities or equivalent.
Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance, and the risk management process.
Critical thinking and analytical skills to understand/analyze complex data and provide insight into risk signaling, trends, and outliers in data.
Excellent communication and coordination skills.
Strong capability in working in a Global/Country matrixed environment.
Data and Digital expertise: experience working with e-databases, clinical and/or project management planning and reporting and analytics systems.
Experience in transformation, leveraging AI and analytics
Ability to understand and navigate diverse cultural contexts
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)
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.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply