Overview
Senior Analytical Monitor x 3 / High Wycombe, UK. Hybrid (3 days onsite weekly), supporting our EMEA team. Located at Johnson & Johnson Innovative Medicine, with focus on site monitoring and Analytical Risk Based Monitoring (ARBM) practices.
Our Integrated Data Analytics and Reporting (IDAR) team seeks experienced individual contributors to join as Senior Analytical Monitors. You will work with Site Managers, other Data Management & Central Monitoring roles, and external service providers to achieve successful partnerships. This role involves executing processes for multiple clinical trials in compliance with applicable laws and policies.
Are you ready to join our team? Please read further.
You Will Be Responsible For
* Conducting activities in compliance with J&J and functional SOPs, processes and policies.
* Supporting innovation or process improvement projects which may include 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.
Analytical Monitor Role-Specific Responsibilities
* 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 to 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 prioritizing sites and guiding critical engagement.
Principal Relationships
* Functional contacts in J&J Innovative Medicine include Site Managers and Local Trial Managers.
* Functional contacts within IDAR include Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, and Clinical Programmers.
* External contacts include External Service Providers.
Qualifications/Requirements
* Bachelor’s degree (e.g., BS, BA) or equivalent professional experience; 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 in 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 critical thinking and problem-solving skills to drive solutions and lead teams to successful outcomes.
* Strong experience with technology platforms and systems used for data collection, analysis and reporting.
* Experience working in diverse, cross-functional, global or multiregional teams.
* Planning and coordination skills; ability to work with cross-functional stakeholders and lead teams in a matrix environment.
* Strong leadership and communication skills (written and verbal) with the ability to influence stakeholders.
* Excellent written and verbal English communication skills.
* Knowledge of clinical drug development processes.
Preferred Experience
* Experience with complex data structures and reporting specifications.
* Experience with external data (e.g., Safety Lab, PK, Biomarkers, ECG, or similar).
* Proficiency in statistical analysis, data modelling, and data visualization techniques.
* Knowledge of Monitoring and RBQM/RBM/QbD concepts.
Benefits
We offer a competitive salary and extensive benefits package. We value work-life balance and provide a flexible working environment along with career development opportunities.
Johnson & Johnson Family of Companies are equal opportunity employers. Qualified applicants will be considered without regard to protected characteristics. Reasonable accommodations are available for applicants with disabilities during the application or interview process. Please contact us to request accommodation.
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