# Senior Clinical System Designer

**Company**: ICON Strategic Solutions
**Location**: Johannesburg, South Africa
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/South-Africa-Johannesburg/Senior-Clinical-System-Designer_JR163461?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/senior-clinical-system-designer-36178524-439/

## Description

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.

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## Skills

### Required
- Python
- R
- Spotfire
- Power BI
- Data Review Methods (DRM)
- GCP
- ICH guidelines
- Project management

### Nice to have
- Experience working with external data providers
- Data Transfer Agreements (DTAs)
- Identifying and implementing opportunities to improve clinical data review and reporting processes
- Sharing best practices, training, or mentoring colleagues

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