Senior Analytical Monitor

Johnson & Johnson; High Wycombe; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A global healthcare company is seeking a Senior Analytical Monitor in High Wycombe. This role involves executing monitoring processes for clinical trials, adhering to regulations, and collaborating with site managers to ensure data quality. Ideal candidates will have substantial experience in the pharmaceutical industry, strong analytical skills, and the ability to work in a hybrid environment, ensuring effective communication and project management. This position offers competitive salary and benefits, fostering growth within the organization.

Benefits

Competitive salary

Flexible working environment

Career development opportunities

Qualifications

• Minimum 8-12 years of experience in Pharmaceutical CRO or Biotech industry.
• Knowledge of trial site operations and study execution is essential.
• Strong knowledge of regulatory guidelines (e.g., ICH-GCP).
• Experience working in diverse clinical research teams with cross-functional setups.

Responsibilities

• Conduct activities in compliance with J&J and functional SOPs.
• Perform analytical monitoring activities for multiple clinical trials.
• Provide timely analytical data insights to support decision-making.

Skills

Gas Chromatography

Laboratory Experience

Analytical Chemistry

FDA Regulations

High‑Performance Liquid Chromatography

Spectroscopy

Research & Development

Teradata

GLP

Alteryx

cGMP

Analytics

Education

Bachelor's degree in Health Sciences or Data Sciences

Advanced degrees (Masters, PhD)

Tools

Data visualization tools

Job description

Job Description

Senior Analytical Monitorx 3 / High Wycombe 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 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.

We are searching for the best talent for Senior Analytical Monitors x 3 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 a head office location in High Wycombe, Buckinghamshire UK. These positions are hybrid (3 days onsite weekly) supporting our EMEA team.

Empowered by technology‑optimised 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 with all relevant laws, regulations, guidelines, policies and procedures. They typically work with minimal direction from their functional position, collaborating closely with Site Managers, other Data Management & Central Monitoring roles, and 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.
• Conducts regular (fit for purpose) reviews at site and subject level that 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 prioritisation and critical engagement.

Principal Relationships

• Functional contacts in J&J Innovative Medicine: Site Managers and Local Trial Managers.
• Functional contacts within IDAR: Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• External contacts: External Service Providers.

Qualifications / Requirements

• Bachelors 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.
• Must be able to work onsite 3 days per week / High Wycombe.
• 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 & problem‑solving skills to drive solutions & 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).
• Proficiency in statistical analysis, data modelling and data visualization techniques.
• Strong knowledge of Monitoring and Risk‑based Quality Management (RBQM) / Risk‑Based Monitoring (RBM) / Quality by Design (QbD) concepts.

Key Skills

• Gas Chromatography
• Laboratory Experience
• Analytical Chemistry
• FDA Regulations
• High‑Performance Liquid Chromatography
• Spectroscopy
• Research & Development
• Teradata
• GLP
• Alteryx
• cGMP
• Analytics

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.

Employment Details

Employment Type: Full‑Time

Experience: years

Vacancy: 1