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For Companies At a Glance
- Tasks: Lead central monitoring activities for global clinical trials and analyse key performance data.
- Company: Join Parexel, a leader in clinical research with a focus on innovation.
- Benefits: Fully remote position with competitive salary and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and patient well-being.
- Why this job: Make a real impact in healthcare by supporting critical drug developments.
- Qualifications: 7+ years in biotech/pharma, with direct Central Monitoring experience and strong analytical 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 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
✨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 diving deep into the role. Understand the key responsibilities and think of examples from your past experience that showcase your skills in central monitoring and data analysis. We want to see how you can shine in this position!
✨Tip Number 3
Don’t just wait for job alerts! Actively search for roles on our website and apply directly. This shows initiative and can set you apart from other candidates who might be taking a more passive approach.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that keeps you fresh in the interviewer's mind and shows your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit!
We think you need these skills to ace Manager, Central Monitoring/Senior Central Monitoring Associate - FSP - Remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Manager, Central Monitoring. Highlight your relevant experience in the biotechnology/pharmaceutical industry and any direct Central Monitoring experience you have. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention your experience with CluePoints and your analytical skills – we love that stuff!
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and concise. Use straightforward language to convey your complex insights, just like you would when presenting to a clinical study team. We appreciate clarity!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. We can’t wait to hear from you!
How to prepare for a job interview at Parexel
✨Know Your Data
Make sure you brush up on your knowledge of Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs). Be prepared to discuss how you've used data analysis tools in previous roles, especially if you've worked with CluePoints. This will show that you understand the analytical side of the role.
✨Showcase Your Experience
With at least 7 years in the industry, you’ll want to highlight specific examples from your past roles that demonstrate your expertise in Central Monitoring. Think about challenges you've faced and how you overcame them, particularly in relation to risk assessment and management.
✨Communicate Clearly
Since excellent written communication skills are a must, practice explaining complex concepts in simple terms. You might be asked to present findings or recommendations, so being able to convey your insights clearly will set you apart from other candidates.
✨Be a Team Player
This role involves collaboration with various teams, so be ready to discuss how you’ve worked effectively with others in the past. Share examples of how you’ve facilitated decisions or supported team dynamics, especially in high-pressure situations.