Lead data-driven oversight of clinical trials. ICON seeks a Lead Analytical Monitor to conduct centralized data review, identify site risks, and guide field teams. 4+ yrs CRO exp & BI tools req.
Become the Data-Driven Guardian of Clinical Trial Quality
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.
We are seeking a strategic Lead Analytical Monitor to join our innovative Risk-Based Monitoring (RBM) team. In this pivotal remote role, you will be at the forefront of modern clinical oversight, using advanced analytics and business intelligence tools to proactively safeguard data quality and site performance. You will translate complex data patterns into actionable intelligence, empowering Site Managers to focus on meaningful site engagement and driving efficiency across our global trials.
Your Mission: Translate Data into Actionable Site Strategy
As a Lead Analytical Monitor, you will be the analytic engine behind risk-based quality management. Your expertise will enable a smarter, more targeted monitoring approach, ensuring resources are focused on the highest risks and most critical data points.
Key Responsibilities
1. Proactive Centralized Data Surveillance
- Conduct ongoing, systematic review of clinical trial data from multiple sources (EDC, labs, ePRO, etc.) to identify trends, anomalies, and early risk indicators.
- Utilize BI and visualization tools (e.g., Spotfire, Power BI) and emerging AI-driven systems to analyze data and detect signals of site performance or data quality issues.
- Apply RBQM/RBM and Quality by Design (QbD) principles to prioritize risks and guide monitoring activities.
2. Strategic Partnership with Site Management
- Synthesize data insights into clear, prescriptive recommendations and action plans for Site Managers (SMs), complete with expected timelines for resolution.
- Proactively communicate findings and collaborate with SMs to support data-driven decision-making and targeted site interventions.
- Build strong, influential relationships with field-based colleagues, managing occasional pushback with professionalism and confidence.
3. Enable Operational Excellence
- Reduce the analytic burden on Site Managers, enabling them to dedicate more time to site relationship management and complex problem-solving.
- Integrate insights from cross-functional teams (Data Management, Safety, Statistics) to provide a holistic view of site health and avoid duplication of effort.
- Contribute to the development and efficient execution of centralized monitoring plans across diverse therapeutic areas.
Who You Are: The Ideal Candidate
You are a hybrid professional: part data scientist, part clinical operations expert. You are naturally curious, analytically rigorous, and possess the soft skills to influence and collaborate effectively in a fully remote, global environment.
Your Required Foundation:
- Minimum of 4+ years of direct experience within a CRO, biotech, or pharmaceutical clinical research environment.
- Proven expertise in clinical data analytics, centralized monitoring, or a closely related function (e.g., clinical data management, RBQM).
- Strong practical understanding of ICH-GCP, RBQM/RBM methodologies, and clinical trial site operations.
- Hands-on experience with data visualization and BI tools (e.g., Spotfire, Power BI, Qlik).
- Excellent statistical thinking and the ability to identify patterns and risk signals in complex datasets.
- Outstanding communication, collaboration, and relationship-building skills.
What Sets You Apart (Preferred):
- Advanced statistical knowledge or formal training in analytics.
- Experience with AI or machine learning applications in clinical data review.
- Prior experience as a Clinical Research Associate (CRA) or Site Manager, providing ground-level understanding of site challenges.
- Ability to program or script (e.g., SQL, R, Python) for data extraction and analysis.
Why Pioneer Centralized Monitoring at ICON?
1. Lead the Digital Transformation of Monitoring
- Be a key player in shaping the future of clinical oversight, working with next-generation AI and analytics platforms.
- Move from a reactive to a proactive, intelligence-driven model of quality management.
2. Career Growth & Visibility
- High-visibility role interfacing with senior operations and data science leadership.
- Clear pathway to Manager, Director, or specialized Data Science roles within Clinical Operations.
- Develop a highly sought-after hybrid skill set at the intersection of data science and clinical research.
3. Remote-First Work & Comprehensive Benefits
- Fully remote position with a global scope.
- Competitive salary and performance-based bonus.
- Generous annual leave entitlements and flexible working arrangements.
- Comprehensive health, life, and disability insurance.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme and dedicated IT/home office support.
Join a Culture that Values Data-Driven Insight
At ICON, we believe that diverse perspectives fuel innovation. We are committed to creating an inclusive, accessible environment and encourage all qualified candidates to apply for this remote opportunity.
Ready to be the analytic powerhouse behind smarter, faster clinical trials?
Apply now to become ICON's Lead Analytical Monitor.
