Role Description
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. We’re looking for an experienced Central Monitoring Expert to play a key role in the definition, implementation and delivery of data review and reporting solutions across clinical trials for one of our largest FSP partners.
Working across Central Monitoring, Clinical Data Management, Clinical Programming and wider Clinical Trial teams, you’ll help translate protocol and data requirements into effective review methods, reporting specifications and visualisations.
This is an experienced-level position requiring strong clinical data expertise and the confidence to work independently across complex data streams. You’ll also help drive consistency, identify opportunities for greater efficiency and share best practices across the wider team.
What you’ll be doing
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Partner with Central Monitoring Managers to understand the outcomes of protocol de-risking activities and translate these into appropriate data review requirements and review methods.
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Define and implement specifications for clinical data review, reporting and visualisation tools.
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Implement protocol-specific data review requirements and methods in line with agreed data review schedules.
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Work with key data stakeholders to establish the purpose and requirements of reporting tools, including the definition, programming and visualisation of different clinical data streams.
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Review trial-specific eDC configurations and Data Transfer Agreements (DTAs) to ensure study requirements and reporting methods are appropriately documented and reflected in reporting solutions.
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Collaborate closely with Clinical Programming to ensure alignment on data outputs and report visualisations.
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Review test outputs and visualisations to ensure accuracy, consistency and alignment with agreed reporting specifications.
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Develop and manage change requests for new or evolving reporting specifications and review methods.
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Take ownership of complex data streams and reporting specifications, working independently with minimal oversight.
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Drive consistency in data deliverables across programmes and delivery units.
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Identify opportunities to standardise and reuse specifications and reporting requirements, improving efficiency and reducing duplication.
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Capture and communicate lessons learned and best practices to support ongoing process optimisation.
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Contribute to process and system improvement initiatives within the wider capability.
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Provide training, troubleshooting and mentoring support to colleagues.
Qualifications
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A Bachelor’s degree or equivalent, preferably in Computer Science or a related discipline.
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A minimum of 5 years’ experience managing data in support of clinical research.
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Strong experience working within clinical trials and an understanding of the clinical development environment.
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Experience with programming languages (Python and R), alongside familiarity with data visualisation tools such as Spotfire and Power BI.
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Experience working with external clinical data, such as Safety Lab, PK, biomarkers, ECG or comparable data streams.
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Experience working with complex data structures and reporting specifications.
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Experience operating in global, cross-functional and multi-regional clinical research teams.
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Working knowledge of Data Review Methods (DRM).
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Working knowledge of GCP and ICH guidelines.
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Demonstrated project management skills and the ability to manage multiple stakeholders and deliverables.
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The ability to work independently, apply sound judgement and take ownership of complex deliverables.
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Excellent written and verbal communication skills in English.
Desirable experience
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Demonstrated experience working with external data providers within a clinical study environment.
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Experience developing and working with Data Transfer Agreements (DTAs).
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Experience identifying and implementing opportunities to improve or standardise clinical data review and reporting processes.
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Experience sharing best practices, training or mentoring colleagues.
Benefits
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Competitive base salary and performance related incentives.
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
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Retirement and pension plans.
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Life assurance and disability coverage.
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Employee assistance programmes and wellbeing resources.
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Learning and development opportunities through structured training and career pathways.
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Benefits may vary depending on role and location.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.