About this role
About the Role As a Central Monitor, you will help ensure data quality, patient safety, and study integrity across the clinical development lifecycle. You’ll work cross-functionally to identify, assess, and mitigate risks using advanced data analytics and central monitoring tools.
What You'll Do
- Facilitate risk assessment throughout the study lifecycle, ensuring proactive identification and management of study risks
- Develop and maintain Central Monitoring Plans in collaboration with study teams
- Support study start-up, conduct, and close-out activities, including KRI (Key Risk Indicator) and QTL (Quality Tolerance Limit) definition
- Act as the primary point of contact for central monitoring tools and systems
- Review and interpret KRI/QTL outputs across sites, countries, and regions
- Lead and contribute to risk mitigation discussions with cross-functional stakeholders
- Oversee outsourced central monitoring deliverables, ensuring quality and timeliness
- Collaborate closely with Study Management on identified issues and trends
- Ensure completeness, accuracy, and compliance of Trial Master File (TMF) documentation
- Support continuous improvement initiatives and process enhancements within Central Monitoring
- Participate in vendor selection, evaluation, and oversight activities
What We're Looking For
- BS/BA degree in biological sciences, statistics, health-related, or computer science field (advanced degree preferred)
- Minimum 6+ years of relevant experience, including at least 4 years in central monitoring, study management, data management, or biostatistics
- Demonstrated expertise in data analytics and/or monitoring across the clinical development lifecycle
- Experience working across multiple therapeutic areas is highly desirable
- Regulatory submission and audit experience
- Proven leadership and process improvement experience
- Vendor oversight and management experience
- Strong cross-functional knowledge of study management, data management, programming, and biostatistics
- Proficiency in MS Office and clinical data systems/tools
- Excellent communication, stakeholder management, and critical thinking skills
- Preferred: Professional certification in a Clinical Development discipline
Nice to Have
- Professional certification in a Clinical Development discipline
Compensation & Benefits
- Competitive salary and benefits; annual leave entitlements; health insurance offerings; retirement planning; Global Employee Assistance Programme LifeWorks; life assurance
- Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
- ICON’s inclusion & belonging culture with a focus on well-being and work-life balance
- Information on benefits available on ICON careers site