Senior Analytical Monitor

Johnson & Johnson Johnson & Johnson · Pharma · High Wycombe, Buckinghamshire, United Kingdom

Senior Analytical Monitor role at Johnson & Johnson focused on clinical data management and analytical risk-based monitoring (ARBM) for clinical trials. The role involves executing processes, analyzing data to detect issues, and collaborating with various stakeholders to ensure data quality, participant safety, and compliance with regulatory guidelines.

What you'd actually do

  1. 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.
  2. Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence
  3. Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level.
  4. 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.
  5. Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.

Skills

Required

  • Bachelor's degree (e.g., BS, BA) or equivalent professional experience
  • Minimum 8-12 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry
  • Knowledge of trial site operations and study execution
  • Strong knowledge of regulatory guidelines (e.g., ICH-GCP)
  • Demonstrated strong understanding of data analysis
  • Familiarity with basic statistical concepts
  • Hands-on experience using data visualization tools
  • Project, Issue, and risk management experience
  • Strong ability to apply critical thinking & problem-solving skills
  • Strong experience working with technology platforms and systems used for the collection, analysis and reporting of data
  • Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional

Nice to have

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

What the JD emphasized

  • strong knowledge of site monitoring
  • Analytical Risk Based Monitoring (ARBM) practices
  • data analytics
  • methods, processes, and technologies
  • strong knowledge of regulatory guidelines (e.g., ICH-GCP)
  • strong understanding of data analysis
  • familiarity with basic statistical concepts
  • hands-on experience using data visualization tools
  • strong ability to apply critical thinking & problem-solving skills
  • strong experience working with technology platforms and systems used for the collection, analysis and reporting of data