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- Tasks: Lead analytical monitoring strategies and ensure compliance across clinical development.
- Company: Join a leading pharma company focused on innovation and quality.
- Benefits: Competitive salary, career development opportunities, and a diverse team culture.
- Why this job: Make a real impact in clinical research while leading a dynamic team.
- Qualifications: Bachelor's degree in relevant field and 6+ years of experience required.
- Other info: Flexible work environment with opportunities for growth and travel.
The predicted salary is between 48000 - 72000 £ per year.
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.
Responsibilities
- Lead planning, execution, and delivery of analytical monitoring strategies, ensuring compliance, quality, and efficiency.
- Shape the function\’s growth, innovation, and capability development, while fostering a diverse and inclusive team culture.
- 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 & Travel
- Location: High Wycombe
- Travel: ~10% (Domestic/International)
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Manager, Analytical Monitoring employer: J&J Family of Companies
Contact Detail:
J&J Family of Companies Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Analytical Monitoring
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their analytical monitoring strategies and be ready to discuss how your experience aligns with their needs. We want you to shine, so practice common interview questions and have your own questions ready!
✨Tip Number 3
Showcase your leadership skills! During interviews, share examples of how you've led teams or projects successfully. We love hearing about your ability to mentor and develop others, especially in a diverse and inclusive environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are ready to drive innovation in analytical monitoring.
We think you need these skills to ace Manager, Analytical Monitoring
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your expertise in analytical monitoring, leadership, and stakeholder engagement to show us you’re the right fit for the role.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you’re passionate about this position. Share specific examples of how you've led teams or improved processes in previous roles, and don’t forget to mention your understanding of regulatory frameworks!
Showcase Your Leadership Skills: Since this role involves leading a team, make sure to emphasise your people management experience. Talk about how you’ve mentored others and fostered a culture of inclusion and innovation in your past positions.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at J&J Family of Companies
✨Know Your Stuff
Make sure you brush up on your knowledge of analytical monitoring, especially in relation to clinical development and innovation programmes. Familiarise yourself with key concepts like Site Monitoring, Central Monitoring, and Analytical Risk-Based Monitoring (ARBM) so you can speak confidently about them during the interview.
✨Showcase Your Leadership Skills
Since this role involves leading a team, be prepared to discuss your leadership style and experiences. Think of specific examples where you've successfully managed a team or project, highlighting how you fostered a culture of inclusion and accountability.
✨Engage with Stakeholders
Demonstrate your ability to engage with various stakeholders by preparing examples of how you've influenced strategic decisions in previous roles. Be ready to discuss how you’ve collaborated with cross-functional teams and managed relationships with vendors or CROs.
✨Be Ready for Problem-Solving
Expect questions around risk and issue management. Prepare to share instances where you've identified and mitigated risks in your projects. Highlight your approach to maintaining compliance and readiness for audits, as this will show your understanding of regulatory frameworks.
