Senior Analytical Monitor

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function: Data Analytics & Computational Sciences

Job Sub Function: Clinical Data Management

Job Category: Professional

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description: Senior Analytical Monitor x 3 / High Wycombe, UK

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

We are searching for the best talent for Senior Analytical Monitors x 3 in our Integrated Data Analytics and Reporting (IDAR) business - experienced individual contributors with strong knowledge of site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies. The head office location is in High Wycombe, Buckinghamshire, UK, and these positions are hybrid (3 days onsite weekly), supporting our EMEA team.

Empowered by technology, optimized processes and targeted data analytics, Analytical Monitors will enable Site Managers to dedicate a greater proportion of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction.

The Senior Analytical Monitor is accountable for executing processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. They typically work with minimal direction from their functional manager. This position 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.

Are you ready to join our team? Then please read further!

• Conducting activities in compliance with J&J and functional SOPs, processes and policies.
• Supporting innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
• Facilitating smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders. Following agreed escalation pathways where needed.

• 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 for multiple trials, often of higher complexity.
• 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.
• Uses various systems, databases and reporting tools to identify potential risks related to 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.

• Functional contacts in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers.
• Functional contacts within IDAR include but are not limited to…