Analyst II,Analytical Monitoring in High Wycombe

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.

We are searching for the best talent for Analyst II Analytical Monitors in our Integrated Data Analytics and Reporting (IDAR) business - individual contributors with 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, Buckinghamshire, 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 Analyst II Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This position receives ongoing direction from their functional manager and/or other experts to achieve objectives. 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.

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.
• Conducts 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 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).
• Approximately 4+ years experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• 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 & problem-solving skills, to drive solutions & helping to 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 ability to communicate effectively (written and verbal).
• Good written and verbal communications 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.
• Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas.
• Knowledge of 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.

Required Skills: Analytical Problem Solving, Clinical Trials Operations, Data Analysis

Preferred Skills: Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems Analysis