Monitor, Research​/Development

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.

• 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.

• 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.

• 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, elevate critical risks, and support follow‑up actions.

• Ensure timely documentation of monitoring activities and findings.

• 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.

• Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of Central Monitoring efforts.

• 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.

• ≥ 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…