Central Monitoring Expert

About the role

ICON Strategic Solutions is looking for an experienced Central Monitoring Expert to define, implement and deliver data review and reporting solutions across clinical trials for one of its largest FSP partners. Working across Central Monitoring, Clinical Data Management, Clinical Programming and wider Clinical Trial teams, the role translates protocol and data requirements into review methods, reporting specifications and visualisations. It is an experienced-level position requiring strong clinical data expertise and the confidence to work independently.

Key responsibilities

• Partner with Central Monitoring Managers to turn protocol de-risking outcomes into data review requirements and methods.
• Define and implement specifications for clinical data review, reporting and visualisation tools.
• Implement protocol-specific data review requirements according to agreed data review schedules.
• Work with data stakeholders to set the purpose and requirements of reporting tools, including definition, programming and visualisation of data streams.
• Review eDC configurations and Data Transfer Agreements (DTAs) so study requirements and reporting methods are properly documented.
• Collaborate with Clinical Programming on data outputs and report visualisations, and review test outputs for accuracy and consistency.
• Develop and manage change requests for new reporting specifications and review methods.
• Drive consistency in data deliverables, identify opportunities to standardise and reuse specifications, and share best practices.
• Capture lessons learned, contribute to process and system improvement, and provide training, troubleshooting and mentoring support.

Required profile

• Bachelor's degree or equivalent, preferably in Computer Science or a related discipline.
• Minimum of 5 years' experience managing data in support of clinical research.
• Strong experience in clinical trials and understanding of the clinical development environment.
• Experience with external clinical data such as Safety Lab, PK, biomarkers, ECG or comparable streams.
• Experience with complex data structures and reporting specifications, and in global, cross-functional, multi-regional teams.
• Working knowledge of Data Review Methods (DRM) and GCP and ICH guidelines.
• Demonstrated project management skills, independent judgement and excellent written and verbal English.
• Legal right to work in the country where the role is based.

Required skills

• Programming languages Python and R
• Data visualisation tools such as Spotfire and Power BI
• Desirable: experience with external data providers, DTAs, and improving or standardising clinical data review and reporting processes

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities