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Job Function:
Data Analytics & Computational SciencesJob Sub Function:
Clinical Data ManagementJob Category:
People LeaderAll Job Posting Locations:
High Wycombe, Buckinghamshire, United KingdomJob 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:
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)
Required Skills:
Preferred Skills:
