Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Tempo Maidenhead, Berkshire, United Kingdom

Job Description:

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 searching for the best talent for a Senior Analytical Monitor in our Integrated Data Analytics and Reporting (IDAR) business - 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 our Maidenhead, Tempo office, UK, and this position is 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, & 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:

• Contributes to the ongoing development of the clinical trial ARBM model and related processes.
• Conducts activities in compliance with J&J and Central Monitoring & SOPs, processes and policies.
• May support 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.
• Facilitates smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders. Follows agreed escalation pathways where needed.

Senior Analytical Monitor 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.
• Senior 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 within IDAR include but are not limited to Functional Leadership, Data Management Leaders, Global and Clinical Data Managers, Data Acquisition Experts, Clinical and Statistical Programmers and Regulatory Medical Writers.
• Functional contacts in J&J Innovative Medicine include but are not limited to Clinical Teams, Trial Delivery Leaders, Trial Delivery Managers, Local Trial Managers, Site Managers, Clinical Risk Managers, and Biostatisticians.
• External contacts include but are not limited to External Service Providers.

Education & Experience 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).
• Approximately 4 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 and risk management experience, helping to 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 Central Monitoring and Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer 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.

#LI-Hybrid

Required Skills:

Preferred Skills:

Advanced Analytics, Clinical Data Management, Clinical Operations, Collaboration, Communication, Database Management, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Interdisciplinary Work, Problem Solving, Process Improvements, Research Ethics, Resource Allocation, Training People