Manager, Analytical Monitoring

Johnson & Johnson; High Wycombe; On-site; GBP 60,000 - 85,000; Full time

Job summary

A global healthcare leader is seeking a Manager, Analytical Monitoring Leader in High Wycombe to oversee analytical monitoring activities. The successful candidate will require a Bachelor’s degree and at least 6 years of experience in pharma or biotech, demonstrating strong leadership and project management skills. This role involves strategic leadership, stakeholder engagement, and ensuring compliance with regulatory standards. The position offers a unique opportunity to drive innovation and foster a diverse team culture.

Qualifications

• 6+ years in pharma, CRO, or biotech with proven people and project management experience.
• Solid understanding of data/site/central monitoring practices and ARBM.
• Excellent leadership, communication, and decision-making skills.

Responsibilities

• Lead analytical monitoring strategy and execution across assigned programs.
• Ensure timely delivery of monitoring activities aligned with regulatory and quality standards.
• Promote a culture of inclusion, innovation, and accountability.

Skills

Leadership

Stakeholder engagement

Analytical Risk-Based Monitoring

Project management

Communication

Decision-making

Education

Bachelor’s degree in Clinical Data Management, Health Sciences, or related field

Master’s/PhD

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 https://www.jnj.com

Data Analytics & Computational Sciences

Clinical Data Management

People Leader

High Wycombe, Buckinghamshire, United Kingdom

Role Overview

The Manager, Analytical Monitoring Leader is a strategic and operational leader responsible for driving analytical monitoring activities across clinical development and innovation programs. This role requires deep expertise in Site Monitoring, Central Monitoring, Data Management, and Analytical Risk-Based Monitoring (ARBM), along with strong leadership, stakeholder engagement, and people management capabilities!

You will lead the planning, execution, and delivery of analytical monitoring strategies, ensuring compliance, quality, and efficiency. You’ll also play a key role in shaping the function’s growth, innovation, and capability development, while fostering a diverse and inclusive team culture.

Key Responsibilities

Strategic & Operational Leadership

• Lead analytical monitoring strategy and execution across assigned programs.
• Ensure timely delivery of monitoring activities aligned with regulatory and quality standards.
• Drive continuous improvement in processes, tools, and methodologies.

Stakeholder Engagement

• Represent Analytical Monitoring in cross-functional forums (GCO, IDAR, GD, JJIM). Influence strategic decisions and collaborate with internal and external stakeholders.
• Serve as primary point of contact for regional/TA/program-level monitoring activities.

Risk & Issue Management

• Proactively identify, assess, and mitigate risks impacting delivery.
• Manage escalations and ensure resolution through appropriate channels and maintain inspection readiness and support audits and CAPA processes.

People & Team Leadership

• Lead, mentor, and develop a team of Analytical Monitors while overseeing recruitment, onboarding, performance management, and career development.
• Promote a culture of inclusion, innovation, and accountability.

Process & Compliance

• Ensure adherence to SOPs, policies, and regulatory guidelines (e.g., ICH-GCP).
• Contribute to development of departmental standards, training, and documentation. Collaborate with vendors and CROs to ensure delivery within scope and budget.

Qualifications

Required

• Bachelor’s degree in Clinical Data Management, Health Sciences, Computer Sciences, or related field (Master’s/PhD preferred).
• 6+ years in pharma, CRO, or biotech with proven people and project management experience.
• Solid understanding of data/site/central monitoring practices and ARBM.
• Deep understanding of regulatory frameworks (e.g., ICH-GCP).
• Experience in matrix environments and partner/vendor management.
• Excellent leadership, communication, and decision-making skills.

Preferred

• Experience with clinical and operational data from diverse sources.
• Proven ability to lead change and drive innovation.
• Strong organizational and negotiation skills.

Location

High Wycombe

Travel

~10% (Domestic/International)