Senior Analytical Monitor – Integrated Data Analytics and Reporting (IDAR)
Location: HighWycombe,Buckinghamshire (hybrid; 3 days onsite weekly, will relocate office to Maidenhead in October2026).
Responsibilities
* Conduct activities in compliance with J&J and functional 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, and influence key cross‑functional stakeholders.
* Follow agreed escalation pathways where needed.
* Perform analytical monitoring activities for clinical trials within assigned scope, supporting execution and close‑out as outlined in the end‑to‑end process for multiple trials.
* Conduct regular (fit‑for‑purpose) reviews at site and subject level to detect issues early and prevent recurrence.
* Collaborate closely with Site Managers and Central Monitoring Managers to act on trends and signals detected.
* Use systems, databases, and reporting tools to identify potential risks related to site and subject data quality, study participant safety, and compliance.
* Provide timely analytical data insights to support Site Managers in site prioritization and critical engagement decisions.
Qualifications
* Bachelor's degree in Health Sciences, Data Sciences, or equivalent professional experience (advanced degrees preferred).
* 8–12 years of experience in the pharmaceutical, CRO, or biotech industry or related field.
* Ability to work onsite 3 days per week in HighWycombe/Maidenhead.
* Knowledge of trial site operations and study execution.
* Strong knowledge of regulatory guidelines (e.g., ICH‑GCP).
* Demonstrated understanding of data analysis and basic statistical concepts.
* Hands‑on experience using data visualization tools, statistical analysis, data modelling, and data visualization techniques.
* Project, issue, and risk management experience with critical thinking and problem‑solving skills.
* Experience with technology platforms and systems used for data collection, analysis, and reporting.
* Experience working in highly diverse, cross‑functional, global, multi‑regional teams.
* Strong leadership, written and verbal communication skills, and ability to influence stakeholders.
* Knowledge of clinical drug development processes and monitoring and risk‑based quality management concepts (RBQM/RBM/QbD).
Preferred Experience
* Working with complex data structures and reporting specifications.
* Working with external data (Safety Lab, PK, Simple Biomarkers, ECG, or similar).
* Proficiency in statistical analysis, data modelling, and data visualization techniques.
* Knowledge of RBQM / RBM / QbD concepts.
Benefits
* Competitive salary and extensive benefits package.
* Flexible working environment that supports work‑life balance.
* Career development opportunities.
Johnson & Johnson is an equal‑opportunity employer. All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process and to perform crucial job functions.
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