Senior Clinical System Designer

As a Senior Clinical System Designer at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

You will 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.

Responsibilities:

• Partner with Central Monitoring Managers to understand protocol de-risking activities and translate these into data review requirements and methods.
• Define and implement specifications for clinical data review, reporting, and visualisation tools.
• Implement protocol-specific data review requirements and methods in line with agreed data review schedules.
• Work with key data stakeholders to establish reporting tool requirements, definitions, programming, and visualisation of clinical data streams.
• Review trial-specific eDC configurations and Data Transfer Agreements (DTAs) to ensure study requirements and reporting methods are documented and reflected in reporting solutions.
• Collaborate with Clinical Programming to ensure alignment on data outputs and report visualisations.
• Review test outputs and visualisations for accuracy, consistency, and alignment with agreed reporting specifications.
• Develop and manage change requests for new or evolving reporting specifications and review methods.
• Take ownership of complex data streams and reporting specifications, working independently with minimal oversight.
• Drive consistency in data deliverables across programs and delivery units.
• Identify opportunities to standardise and reuse specifications and reporting requirements, improving efficiency and reducing duplication.
• Capture and communicate lessons learned and best practices to support ongoing process optimisation.
• Contribute to process and system improvement initiatives within the wider capability.
• Provide training, troubleshooting, and mentoring support to colleagues.

Requirements:

• 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 working within clinical trials and understanding of the clinical development environment.
• Experience with programming languages (Python and R), data visualisation tools (Spotfire and Power BI).
• Experience working with external clinical data (Safety Lab, PK, biomarkers, ECG).
• Experience working with complex data structures and reporting specifications.
• Working knowledge of Data Review Methods (DRM) and GCP and ICH guidelines.
• Demonstrated project management skills and ability to manage multiple stakeholders and deliverables.
• Excellent written and verbal communication skills in English.

Benefits:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programs, including medical, dental, and vision coverage.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Learning and development opportunities.