Overview
Analyst II Analytical Monitor x 2 / High Wycombe, UK. Hybrid (3 days on-site weekly) for our EMEA team. Join our Integrated Data Analytics and Reporting (IDAR) business to support site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies.
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 the 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.
Learn more at https://www.jnj.com/innovative-medicine
You Will Be Responsible For
* Conducting activities in compliance with J&J 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. Follows 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.
* Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will 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.
* Accesses various systems, databases and reporting tools to identify potential risks related to the 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 prioritization and 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, Clinical Programmers.
* External contacts include External Service Providers.
Qualifications / Requirements
* Bachelor's 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 4-8 years’ experience in Pharmaceutical, CRO or Biotech industry or related field.
* Knowledge of trial site operations and study execution.
* Working knowledge of regulatory guidelines (e.g., ICH-GCP).
* Demonstrated understanding of data analysis and familiarity with basic statistical concepts.
* Project, Issue, and risk management experience with ability to apply critical thinking and problem-solving skills, to drive solutions and help lead teams to successful outcomes.
* Experience working with technology platforms and systems used for the collection, analysis and reporting of data.
* Ability to effectively collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.
* Strong written and verbal communication skills in English.
* Knowledge of clinical drug development processes.
Preferred Experience
* Working with complex data structures and reporting specifications.
* Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
* Proficiency in statistical analysis, data modelling, and data visualization techniques, or strong knowledge in these areas.
* Knowledge of RBQM/RBM/QbD concepts.
Benefits
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, with a flexible working environment and strong emphasis on work-life balance. We provide career development opportunities for those who want to grow and be part of our organization.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any characteristic protected by law. We provide reasonable accommodations to assist applicants with disabilities during the job application or interview process, to perform crucial job functions, and to receive other benefits of employment. Please contact us to request accommodation.
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