Senior Analytical Monitor

Senior Analytical Monitor at Johnson & Johnson, located in High Wycombe, Buckinghamshire, UK. Hybrid position (3 days onsite per week). The role focuses on executing data‑analytics monitoring for clinical trials and supporting site managers to improve performance, data reliability, and site satisfaction.

Key Responsibilities

• Conduct monitoring activities in compliance with J&J SOPs, processes, and policies.
• Support innovation or process‑improvement projects, including requirements development, user acceptance testing, and identification of improvements to analytical tools.
• Facilitate smooth and effective communication, manage multiple communication streams, influence key cross‑functional stakeholders, and follow agreed escalation pathways.
• Perform analytical monitoring activities for multiple clinical trials, including execution and close‑out as outlined in the end‑to‑end process.
• Conduct regular, fit‑for‑purpose reviews at site and subject levels to detect early issues and prevent recurrence.
• Collaborate closely with Site Managers and Central Monitoring Managers to action trends and signals identified at the site and subject levels.
• Use various systems, databases, and reporting tools to identify potential risks related to site and subject‑level data quality, study participant safety, and compliance.
• Provide timely analytical data insights to support Site Managers in site prioritization and critical engagement decisions.

Principal Relationships

• Internal contacts: Site Managers, Local Trial Managers, Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• External contacts: External Service Providers.

Qualifications and Requirements

• Bachelor’s degree in Health Sciences or Data Sciences (or equivalent). Advanced degrees preferred.
• 8–12 years of experience in the Pharmaceutical, CRO, Biotech, or a related field.
• Must be able to work onsite 3 days per week in High Wycombe / Maidenhead.
• Knowledge of trial site operations and study execution.
• Strong knowledge of regulatory guidelines (e.g., ICH‑GCP).
• Strong data‑analysis skills, basic statistical concepts, and hands‑on experience with data‑visualisation tools.
• Project, issue, and risk‑management experience; strong critical thinking and problem‑solving skills.
• Experience with technology platforms and systems used for collection, analysis, and reporting of data.
• Experience working in diverse, global, cross‑functional clinical research teams.
• Planning and coordination skills; ability to lead teams in a matrix environment and partner with/manage stakeholders.
• Strong leadership and communication skills (written and verbal); ability to influence stakeholders.
• Excellent written and verbal communication skills in English.
• Strong knowledge of clinical drug‑development processes.

Preferred Experience

• Working with complex data structures and reporting specifications.
• Working with external data (Safety Lab, PK, Biomarkers, ECG, or similar).
• Proficiency in statistical analysis, data modelling, and data‑visualisation techniques.
• Strong knowledge of Monitoring and Risk‑Based Quality Management (RBQM), Risk‑Based Monitoring (RBM), and Quality by Design (QbD) concepts.

Benefits

• Competitive salary, extensive benefits package, flexible working environment, and career‑development opportunities.

EEO Statement

Johnson & Johnson Family of Companies are equal‑opportunity employers. All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will provide reasonable accommodation for applicants with disabilities.