Overview
Senior Analytical Monitor x 3 / High Wycombe, UK — hybrid (3 days onsite weekly) role in the Integrated Data Analytics and Reporting (IDAR) business for Johnson & Johnson Innovative Medicine. The head office is in High Wycombe, Buckinghamshire, UK.
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
We are seeking experienced individual contributors with strong knowledge of site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies. The head office location is in High Wycombe, UK, and these positions are hybrid (3 days onsite weekly), supporting our EMEA team.
Empowered by technology, optimized processes and targeted data analytics, Analytical Monitors will enable Site Managers to dedicate a greater proportion of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction.
The Senior Analytical Monitor is accountable for executing processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. They typically work with minimal direction from their functional manager. This position collaborates closely with Site Managers, other Data Management & Central Monitoring roles, and other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.
Are you ready to join our team? Then 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 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 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.
* 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.
* 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 making decisions on site prioritization and critical engagement.
Principal Relationships
* Functional contacts in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers.
* Functional contacts within IDAR include but are not limited to Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
* External contacts include but are not limited to 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 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 and familiarity with basic statistical concepts and hands-on experience using data visualization tools.
* Project, Issue, and risk management experience with strong ability to apply critical thinking and problem-solving skills, to drive solutions and help lead teams to successful outcomes.
* 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.
* Planning and coordination skills. Experience working with cross-functional stakeholders and leading teams in a matrix environment and partnering with/managing 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 e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
* Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas.
* Strong knowledge of Monitoring and Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts.
Benefits
We offer a competitive salary and an extensive benefits package. The health and well-being of our employees is a priority; we offer a flexible working environment with a focus on work-life balance. We also provide career development opportunities for those who want to grow and be part of our organisation.
Johnson & Johnson Family of Companies are equal opportunity employers, and 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, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Additional Details
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Other
* Industries: Pharmaceutical Manufacturing
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