Central Monitoring Expert

Central Monitoring Expert

Location

Warsaw, Johannesburg

Reference: JR163461

About the role

Senior Clinical System Designer

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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 You will:

• 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.
• 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 the purpose and requirements of reporting tools, including the definition, programming and visualisation of different clinical data streams.
• 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.
• Collaborate closely with Clinical Programming to ensure alignment on data outputs and report visualisations.
• Review test outputs and visualisations to ensure 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 programmes 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.

What we’re looking for You’ll bring:

• A Bachelor’s degree or equivalent, preferably in Computer Science or a related discipline.
• A minimum of 5 years’ experience managing data in support of clinical research.
• Strong experience working within clinical trials and an understanding of the clinical development environment.
• Experience with programming languages (Python and R), alongside familiarity with data visualisation tools such as Spotfire and Power BI.
• Experience working with external clinical data, such as Safety Lab, PK, biomarkers, ECG or comparable data streams.
• Experience working with complex data structures and reporting specifications.
• Experience operating in global, cross-functional and multi-regional clinical research teams.
• Working knowledge of Data Review Methods (DRM).
• Working knowledge of GCP and ICH guidelines.
• Demonstrated project management skills and the ability to manage multiple stakeholders and deliverables.
• The ability to work independently, apply sound judgement and take ownership of complex deliverables.
• Excellent written and verbal communication skills in English.

Desirable experience It would be particularly valuable if you have:

• Demonstrated experience working with external data providers within a clinical study environment.
• Experience developing and working with Data Transfer Agreements (DTAs).
• Experience identifying and implementing opportunities to improve or standardise clinical data review and reporting processes.
• Experience sharing best practices, training or mentoring colleagues.

What ICON can offer you Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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Location

Warsaw, Johannesburg

Reference: JR163461

Categories Clinical Systems

Remote Working Remote

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