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Analyst II Analytical Monitor - Job Opportunity at Johnson & Johnson

High Wycombe, United Kingdom
Full-time
Mid-level
Posted: June 23, 2025
Hybrid
£45,000 - £65,000 per year based on mid-level pharmaceutical analytics roles in High Wycombe area, with Johnson & Johnson typically offering competitive packages 10-15% above market average for similar positions

Benefits

Competitive salary package positioned to attract top talent in pharmaceutical analytics
Comprehensive health and wellness programs reflecting company's healthcare leadership
Flexible hybrid working environment with 3 days onsite weekly, supporting work-life integration
Professional development opportunities within a global pharmaceutical leader
Career advancement pathways in innovative medicine and data analytics
Equal opportunity employment with disability accommodation support

Key Responsibilities

Execute analytical monitoring activities across multiple clinical trials ensuring regulatory compliance and data integrity for drug development programs
Drive innovation in risk-based monitoring through requirements development, user acceptance testing, and analytical tool optimization
Provide strategic data insights to Site Managers for critical decision-making on site prioritization and resource allocation
Conduct comprehensive site and subject-level reviews to enable early risk detection and prevent data quality issues
Collaborate with cross-functional teams including Site Managers and Central Monitoring to action trend analysis and implement corrective measures
Access and analyze complex databases to identify potential risks affecting participant safety and regulatory compliance
Facilitate effective communication across multiple stakeholder groups while managing escalation pathways

Requirements

Education

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).

Experience

Minimum 4-8 years' experience in Pharmaceutical, CRO or Biotech industry or related field or industry

Required Skills

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 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 Strong ability to communicate effectively (written and verbal) Good written and verbal communications skills (in English) Knowledge of clinical drug development processes Working with complex data structures and reporting specifications Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG Proficiency in statistical analysis, data modelling, and data visualization techniques Knowledge of Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts
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Industry Trends

The pharmaceutical industry is experiencing a significant shift toward Risk-Based Quality Management (RBQM) and analytical monitoring approaches, driven by regulatory guidance from FDA and EMA emphasizing quality by design principles. This transformation is fundamentally changing how clinical trials are monitored, moving from traditional 100% source data verification to targeted, risk-based approaches that leverage real-time data analytics. Digital transformation in clinical trials has accelerated post-COVID, with companies investing heavily in integrated data analytics platforms and remote monitoring capabilities. The integration of artificial intelligence and machine learning in clinical data monitoring is becoming standard practice, requiring professionals who can bridge statistical analysis with regulatory compliance. The European Medicines Agency's focus on decentralized clinical trials and real-world evidence is creating new opportunities for analytical monitors who can work with diverse data sources including wearables, electronic health records, and patient-reported outcomes. This trend is particularly strong in the UK and EU markets where regulatory frameworks are evolving to support innovative trial designs.

Role Significance

Typically works within teams of 8-12 professionals including Site Managers, Central Monitoring specialists, and Data Management experts, often supporting 3-5 concurrent clinical trials
This mid-level individual contributor role represents a critical function in clinical trial execution with direct impact on drug development timelines and regulatory submissions. The position requires independent decision-making on data quality issues while collaborating with senior stakeholders across multiple therapeutic areas.

Key Projects

Implementation of risk-based monitoring strategies for Phase II and III clinical trials Development and validation of analytical dashboards for real-time site performance monitoring Cross-functional collaboration on regulatory inspection readiness and data integrity audits Integration of external data sources including central laboratories and imaging centers into monitoring workflows

Success Factors

Deep understanding of regulatory requirements combined with practical application of statistical concepts is essential for identifying meaningful signals in complex clinical datasets while maintaining compliance with ICH-GCP guidelines. Strong collaborative skills are critical as the role requires building relationships with Site Managers, investigators, and external service providers while managing competing priorities across multiple trials and therapeutic areas. Adaptability to evolving technology platforms and analytical tools is crucial as the pharmaceutical industry rapidly adopts new digital solutions for clinical trial monitoring and data visualization. Proactive communication and escalation management skills are vital for preventing data quality issues from impacting trial timelines and regulatory submissions.

Market Demand

High demand driven by industry-wide adoption of risk-based monitoring and increased regulatory focus on data quality and patient safety in clinical trials

Important Skills

Critical Skills

Statistical analysis and data visualization skills are fundamental as the role requires interpreting complex clinical datasets to identify trends and potential risks that could impact patient safety or data integrity. Proficiency in these areas directly correlates with ability to provide actionable insights to Site Managers and regulatory teams. Regulatory knowledge, particularly ICH-GCP guidelines, is essential for ensuring all monitoring activities meet global standards for clinical trial conduct. This expertise is critical for supporting regulatory inspections and maintaining Johnson & Johnson's reputation for clinical excellence. Cross-functional collaboration abilities are vital given the role's requirement to work effectively with Site Managers, Data Management teams, and external service providers while managing multiple communication streams and competing priorities.

Beneficial Skills

Experience with artificial intelligence and machine learning applications in clinical data analysis would provide significant advantages as the industry moves toward predictive analytics and automated signal detection Knowledge of decentralized clinical trial technologies and remote monitoring tools would be valuable as Johnson & Johnson continues to innovate in digital health and patient-centric trial designs Understanding of real-world evidence and health economics would enhance career prospects as pharmaceutical companies increasingly focus on demonstrating value beyond traditional clinical endpoints

Unique Aspects

Opportunity to work on cutting-edge analytical monitoring technologies within the world's largest pharmaceutical company, providing exposure to diverse therapeutic areas and innovative trial designs
Direct involvement in developing next-generation risk-based monitoring approaches that are setting industry standards for clinical trial quality and efficiency
Access to Johnson & Johnson's extensive internal training programs and career development resources, including potential for international assignments and cross-functional rotations
Contribution to life-saving medicines across multiple therapeutic areas with direct impact on patient outcomes and regulatory approvals

Career Growth

Typical progression to senior roles within 2-3 years with demonstrated expertise in risk-based monitoring and successful trial execution

Potential Next Roles

Senior Analytical Monitor with expanded therapeutic area responsibility and mentoring duties Central Monitoring Manager overseeing analytical monitoring strategies across multiple programs Clinical Data Science Lead focusing on advanced analytics and machine learning applications Regulatory Affairs Associate specializing in data integrity and inspection readiness

Company Overview

Johnson & Johnson

Johnson & Johnson is the world's largest healthcare company with over $95 billion in annual revenue, operating across pharmaceuticals, medical devices, and consumer products. The company's Innovative Medicine division focuses on breakthrough treatments in oncology, immunology, neuroscience, and infectious diseases, with a pipeline of over 60 potential blockbuster drugs.

Global industry leader with strongest market position in pharmaceutical innovation, consistently ranking in top 3 for R&D investment and new drug approvals. The company's integrated approach across the healthcare spectrum provides unique competitive advantages in clinical development.
Johnson & Johnson's EMEA headquarters serves as a critical hub for European clinical development activities, with High Wycombe location supporting regulatory submissions to EMA and national health authorities across 40+ countries in the region.
Known for strong emphasis on scientific excellence, patient-centric approach, and collaborative culture that encourages innovation. The company's credo-based values system creates an environment focused on responsibility to patients, employees, and communities.
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