Senior Analytical Monitor

Job Description

Senior Analytical Monitorx 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 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.

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 a head office location in High Wycombe, Buckinghamshire UK. These positions are hybrid (3 days onsite weekly) supporting our EMEA team.

Empowered by technology‑optimised 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 with all relevant laws, regulations, guidelines, policies and procedures. They typically work with minimal direction from their functional position, collaborating closely with Site Managers, other Data Management & Central Monitoring roles, and 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.
• Conducts regular (fit for purpose) reviews at site and subject level that 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 prioritisation and critical engagement.

• Functional contacts in J&J Innovative Medicine:
  Site Managers and Local Trial Managers.
• Functional contacts within IDAR:
  Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• External contacts:
  External Service Providers.

• Bachelors degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD).
• Minimum 8‑12 years of experience in Pharmaceutical CRO or Biotech industry or related field.
• Must be able to work onsite 3 days per week / High Wycombe.
• Knowledge of trial site operations and study execution.
• Strong knowledge of regulatory guidelines (e.g., ICH‑GCP).
• Demonstrated strong understanding of data analysis and familiarity with basic statistical concepts and hands‑on experience using data visualization tools.
• Project, issue and risk management experience with strong ability to apply critical thinking &…