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Overview:

The Analytical Monitor is responsible for a range of tasks that spans the areas of targeted data analytics, risk identification & mitigation at site & subject level.

The Analytical Monitor is an individual contributor role that supports the execution of analytical monitoring activities that will enable Site Managers to perform guided issue/ risk management.

The Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. 

The Analytical Monitor collaborates closely with Site Managers, other Data Management & Central Monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.

Responsibilities:

• Conducts activities in compliance with sponsor functional SOPs, processes and policies. 
• Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed. 
• May support innovation or process improvement projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools & processes. 
• Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process. 
• Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence 
• Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level. 
• Accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals 
• Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.
• May perform analytical monitoring activities on mid to high complexity clinical trials
• May support innovation or process improvement projects of mid to high complexity
• May support training/ mentoring of Base Analytical Monitors associates

Requirements/Qualifications:

• Advanced degrees preferred (e.g., Masters,)  

• Approximately 6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry

• Knowledge of trial site operations and study execution 

• Demonstrated understanding of data analysis and familiarity with basic statistical concepts. 

• Project, Issue, and risk management experience with ability to apply critical thinking & problem-solving skills, to drive solutions & helping to lead teams to successful outcomes. 

Preferred Experience:

• Working with complex data structures and reporting specifications 
• Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar. 
• Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas. 
• Strong Knowledge of Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts

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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