Central Monitor

Title - Central Monitor Location - EMEA, remote Sponsor dedicated As a Central Monitor you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within one of the largest pharmaceutical companies in the world, 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 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 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.

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 must have the following:

• 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.
• 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, site), 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 the sponsors 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 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.

What ICON can offer you: Our success depends on the quality of our people. Thats why weve 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 familys needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work weve done to become a more inclusive organisation. Were 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 through the form below. 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 - theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.

Information :

• Company : ICON
• Position : Central Monitor
• Location : Remote
• Country : ZA