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 - 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.

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.

• 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.

• Document findings, escalate critical risks, and support follow-up actions.

• Ensure timely documentation of monitoring activities and findings.

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.

• Act as a key interface between Central Monitoring, Clinical Study Teams, and Investigators.

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.

• Contribute to training and knowledge-sharing initiatives within the Central Monitoring team.

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.

• ≥ 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.

• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and our clients standards.

• 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. Organizational awareness, including significant experience working cross- functionally.

• Strong technical, analytical and quantitative problem-solving skills. Technical ability to use the relevant technology and risk-based tools/platforms effectively.

• Data and Digital expertise: experience working with e-databases, clinical and/or project management planning and reporting and analytics systems.

• Strong project management skill with demonstrated ability to meet timelines.

• Understanding team dynamics: recognizing the diverse talents, personalities, and working styles within a team to create a connected and productive work environment.

• Experience in transformation, leveraging AI and analytics

• Ability to understand and navigate diverse cultural contexts. This includes fostering inclusive environments and developing talents across different countries.

• Extensive knowledge of appropriate therapeutic area preferred

What ICON can offer you:

Visit our careers site 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.

Are you a current ICON Employee? Please click here to apply