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For Companies At a Glance
- Tasks: Lead central monitoring for global trials and analyse key performance data.
- Company: Join Parexel, a leader in clinical studies with a focus on innovation.
- Benefits: Fully remote role with competitive salary and opportunities for professional growth.
- Other info: Be part of a dynamic team that supports top-selling drugs and niche developments.
- Why this job: Make a real impact in clinical development and support life-changing therapies.
- Qualifications: 7+ years in biotech/pharma, with strong data analysis and communication skills.
The predicted salary is between 60000 - 75000 £ per year.
Parexel are currently recruiting for an experienced Central Monitoring professional in either the UK or Ireland to join our FSP program as a Manager, Central Monitoring. In this role you will be accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies within a therapeutic area and program-level. This will be a fully remote home-based position.
Some Specifics About This Advertised Role
- Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
- Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
- Oversee Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
- Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring intervention.
- Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
- Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
- Act as Central Monitoring subject matter expert. Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on RBQM processes.
- Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.
What We Are Looking For In This Role
- At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience.
- Site monitoring or data management experience essential.
- Experience using CluePoints is essential.
- Excellent written communication skills, with the ability to convey complex technical and analytical insights in a clear and concise manner.
- Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs.
- Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures.
Manager, Central Monitoring/Senior Central Monitoring Associate - FSP - Remote in Uxbridge employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Central Monitoring/Senior Central Monitoring Associate - FSP - Remote in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Parexel or similar companies. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs). Be ready to discuss how you've used these in past roles, as this will show you're the right fit for the Central Monitoring position.
✨Tip Number 3
Don’t just wait for job alerts! Regularly check our website for new postings and apply directly. This shows your enthusiasm and commitment to joining the team at Parexel.
✨Tip Number 4
Follow up after interviews with a thank-you email. Mention something specific from your conversation to remind them of your fit for the role. It’s a small gesture that can make a big difference!
We think you need these skills to ace Manager, Central Monitoring/Senior Central Monitoring Associate - FSP - Remote in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your relevant experience in Central Monitoring and the biotech/pharmaceutical industry. Use keywords from the job description to show we’re on the same page!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share specific examples of your past work that align with the responsibilities listed in the job description. Let us see your personality and passion for the role.
Showcase Your Communication Skills: Since excellent written communication is key, ensure your application is clear and concise. Avoid jargon unless it’s necessary, and make sure your insights are easy to understand. We want to see how you convey complex ideas!
Apply Through Our Website: Don’t forget to apply 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 you’re keen on joining our team at Parexel!
How to prepare for a job interview at Parexel
✨Know Your Data Inside Out
Make sure you’re well-versed in the key risk indicators (KRIs) and key performance indicators (KPIs) relevant to the role. Brush up on how these metrics are used in central monitoring and be ready to discuss specific examples from your past experience.
✨Showcase Your Analytical Skills
Prepare to demonstrate your analytical prowess during the interview. Think of scenarios where you’ve successfully interpreted data trends or conducted root cause analyses. Be ready to explain your thought process and the impact of your findings on study outcomes.
✨Familiarise Yourself with RBQM Methodologies
Since this role involves Risk Based Quality Management, it’s crucial to understand its principles. Research how RBQM is applied in clinical trials and be prepared to discuss how you would implement these methodologies in your work.
✨Communicate Clearly and Confidently
Given the importance of presenting findings to clinical study teams, practice articulating complex information in a straightforward manner. Use examples from your experience to illustrate your communication skills and ensure you can convey technical insights effectively.