Senior Clinical System Lead

ICON

Location
Johannesburg, Gauteng
Minimum qualification
Bachelor's degree
Closing date

First listed . Last checked at source .

In brief

**Overview** This Senior Clinical System Lead role at ICON is critical for the successful delivery of clinical trial systems that support global clinical research programmes. The individual will act as the lead systems expert across one or more studies, overseeing the planning, implementation, maintenance, and optimisation of clinical systems to ensure high-quality, compliant solutions that enable efficient study execution and data collection. The role involves working closely with sponsors, study teams, and technology partners to provide technical and operational leadership throughout the clinical trial lifecycle, while driving continuous improvement and best practices across Clinical Systems. **What you will do** * Leading the planning, setup, maintenance, and oversight of clinical systems used within global clinical trials. * Acting as the clinical systems lead for assigned studies, partnering with internal teams, sponsors, and external vendors to ensure successful delivery. * Translating protocol and study requirements into effective clinical system solutions that support data collection, review, and reporting activities. * Providing oversight of system integrations, data flows, and vendor-managed technologies to ensure data quality and operational efficiency. * Identifying risks, managing issues, and communicating project status to key stakeholders throughout the study lifecycle. * Supporting study start-up activities, project meetings, system reviews, and customer interactions. * Reviewing technical documentation, system specifications, and study deliverables to ensure quality and regulatory compliance. * Leading user acceptance testing and quality review activities for system enhancements and implementations. * Mentoring junior team members and contributing to process improvement, innovation, and best practice initiatives. * Supporting business development activities by providing subject matter expertise during proposals and bid defence meetings. **Requirements (from the original advert)** * Bachelor's degree in Computer Science, Information Technology, Life Sciences, Health Informatics, Data Science, or a related discipline. * Significant experience within Clinical Data Science, Clinical Systems, Clinical Data Management, or Electronic Data Capture EDC environments. * Strong understanding of clinical trial processes, GCP, and regulatory requirements within regulated clinical research environments. * Experience leading the implementation, management, and optimisation of clinical systems across multiple studies or programmes. * Knowledge of clinical data platforms, data flows, integrations, and system validation principles. * Demonstrated project leadership skills with experience managing multiple priorities and stakeholders. **Who should apply** Candidates for the Senior Clinical System Lead position should possess a Bachelor's degree in Computer Science, Information Technology, Life Sciences, Health Informatics, Data Science, or a related discipline. Applicants must have significant experience within Clinical Data Science, Clinical Systems, Clinical Data Management, or Electronic Data Capture (EDC) environments. A strong understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements in regulated clinical research environments is essential. The role requires experience leading the implementation, management, and optimisation of clinical systems across multiple studies or programmes, along with knowledge of clinical data platforms, data flows, integrations, and system validation principles. Demonstrated project leadership skills, including the ability to manage multiple priorities and stakeholders, are also required for this position, which involves acting as a lead systems expert and providing technical and operational leadership. **Deadline** Not specified **Reference** Original posting: https://www.myjobmag.co.za/job/senior-clinical-system-lead-icon-plc-1 Source: myjobmag

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At a glance

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    Job description

    * As a Senior Clinical System Lead at ICON, you will play a critical role in the successful delivery of clinical trial systems that support global clinical research programmes. Acting as the lead systems expert across one or more studies, you will oversee the planning, implementation, maitenance, and optimisation of clinical systems, ensuring high-quality, compliant solutions that enable efficient study execution and data collection. * Working closely with sponsors, study teams, and technology partners, you will provide technical and operational leadership throughout the clinical trial lifecycle while driving continuous improvement and best practices across Clinical Systems. What You Will Be Doing * Leading the planning, setup, maintenance, and oversight of clinical systems used within global clinical trials. * Acting as the clinical systems lead for assigned studies, partnering with internal teams, sponsors, and external vendors to ensure successful delivery. * Translating protocol and study requirements into effective clinical system solutions that support data collection, review, and reporting activities. * Providing oversight of system integrations, data flows, and vendor-managed technologies to ensure data quality and operational efficiency. * Identifying risks, managing issues, and communicating project status to key stakeholders throughout the study lifecycle. * Supporting study start-up activities, project meetings, system reviews, and customer interactions. * Reviewing technical documentation, system specifications, and study deliverables to ensure quality and regulatory compliance. * Leading user acceptance testing and quality review activities for system enhancements and implementations. * Mentoring junior team members and contributing to process improvement, innovation, and best practice initiatives. * Supporting business development activities by providing subject matter expertise during proposals and bid defence meetings. You Will Have * Bachelor's degree in Computer Science, Information Technology, Life Sciences, Health Informatics, Data Science, or a related discipline. * Significant experience within Clinical Data Science, Clinical Systems, Clinical Data Management, or Electronic Data Capture EDC environments. * Strong understanding of clinical trial processes, GCP, and regulatory requirements within regulated clinical research environments. * Experience leading the implementation, management, and optimisation of clinical systems across multiple studies or programmes. * Knowledge of clinical data platforms, data flows, integrations, and system validation principles. * Demonstrated project leadership skills with experience managing multiple priorities and stakeholders.

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