Central Monitoring Reporting Expert - homebased (FSP)

• 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 the 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 the definition new reporting specifications or review methods
• Review trial specific eDC configuration and Data Transfer Agreements (tsDTAs) for documentation of study requirements and methods for reporting and visualization
• Liaise with clinical programming to ensure alignment and agreement of data output and report visualization.
• Review of test output and visualizations to ensure accuracy and consistency with data reporting specifications and/or set-up requirements.
• Executes deliverables for more complex data streams and reporting specifications
• Able to ensure consistency across deliverables for data within a program or delivery unit
• Identifies opportunities for efficiencies in re-use of similar specifications and reporting requirements
• Ability to work more independently with minimal oversight
• Ability to 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 peer colleagues

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 teams within clinical research; cross-functional global
• Working knowledge of DRM.
• Working knowledge of GCP/ICH guidelines
• Excellent written and verbal communication in English

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