Central Monitoring Reporting Expert - homebased (FSP)

IQVIA; Bellville; On-site; ZAR 500,000 - 900,000; Full time

Job summary

A leading global provider of clinical research services, IQVIA seeks a Central Monitoring Reporting Expert. This role is crucial for the implementation and management of data reporting tools in compliance with clinical trial protocols. The candidate will collaborate with diverse teams and require substantial experience in clinical data management and project execution.

Qualifications

• Minimum of 5 years’ experience managing data in support of clinical research.
• Experience working with complex data structures and reporting specifications.
• Experience working in highly diverse, cross-functional, global teams.

Responsibilities

• Responsible for setup and implementation of data reporting specifications and tools.
• Collaborate with monitoring managers to identify review requirements.
• Manage complex data streams and identify opportunities for efficiency.

Skills

Project Management

Data Management

Clinical Research

Communication

Problem Solving

Job description

Central Monitoring Reporting Expert

The Central Monitoring Reporting Expert is responsible for the comprehensive setup and implementation of data reporting specifications and tools aligned with clinical trial protocols. This role supports centralized monitoring by configuring data review platforms using a wide range of data sources, including electronic data capture (eDC), central labs, ECG, imaging, biomarkers, genomics, real-world data, electronic health records, ePROs, wearables, and other digital technologies. All activities are conducted in compliance with applicable standard operating procedures, regulatory requirements, and ICH-GCP guidelines.

Key responsibilities include collaborating with monitoring managers to identify review requirements and methods, executing data review specifications, and implementing review schedules. The expert works closely with stakeholders to define, program, and visualize data reporting tools using established standards and templates. They review eDC configurations and data transfer agreements (tsDTAs), ensure alignment with clinical programming, and validate test outputs for accuracy and consistency.

At a more advanced level, the expert manages complex data streams, ensures consistency across programs or delivery units, and identifies opportunities for efficiency through reuse of specifications. They contribute to process and system improvements, share best practices, and provide training, mentoring, and troubleshooting support to peers.

The role involves collaboration with central monitoring managers, clinical trial teams, data management teams, and various functional experts such as clinical programmers, data managers, biostatisticians, and study leaders. External interactions may include technology partners and vendors.

The role

• Liaison with Central Monitoring Managers for outcomes of protocol de-risking for identification of Review Requirements and Review Methods
• Execute deliverables including specifications for data review and reporting tools.
• Implementation of data review requirements and review methods per protocol-defined data review schedule.
• Liaise with key data stakeholders to establish the purpose of data reporting tools and requirements for the definition, programming, and visualization of data for each data stream utilizing available standards and templates.
• Create change requests for defining new reporting specifications or review methods.
• Review trial-specific eDC configurations and Data Transfer Agreements (tsDTA’s) for documentation of study requirements and reporting/visualization methods.
• Liaise with clinical programming to ensure alignment and agreement of data output and report visualization.
• Review test outputs and visualizations to ensure accuracy and consistency with specifications and setup requirements.
• Execute deliverables for more complex data streams and reporting specifications.
• Ensure consistency across deliverables within a program or delivery unit.
• Identify opportunities for efficiencies through reuse of specifications and reporting requirements.
• Work more independently with minimal oversight.
• Identify and communicate lessons learned and best practices to colleagues and CP team members to support process optimization.
• Participate in process and system improvement initiatives within the Capabilities Center.
• Provide training, troubleshooting, and mentoring support for peers.

Requirements

• Minimum of 5 years’ experience managing data in support of clinical research.
• Experience working with complex data structures and reporting specifications.
• Demonstrated project management skills.
• Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
• Experience working on clinical trials.
• Experience working in highly diverse, cross-functional, global teams within clinical research.
• Working knowledge of DRM.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication skills in English.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com