Manager, Analytical Monitoring

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Job Description:

Are you ready to make a difference

At Johnson & Johnson we are committed to addressing and solving some of the most meaningful unmet medical needs through creating an environment where our employees feel valued and can reach their potential. This commitment is embedded in our Credo!

Role Overview:

TheManager Analytical Monitoring Leaderis a strategic and operational leader responsible for driving analytical monitoring activities across clinical development and innovation programs. This role requires deep expertise inSite Monitoring Central Monitoring Data Management andAnalytical 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. Youll also play a key role in shaping the functions 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:

• Bachelors degree in Clinical Data Management Health Sciences Computer Sciences or related field (Masters/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)

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