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- Tasks: Lead central monitoring activities for global clinical trials and analyse key performance data.
- Company: Join a leading biotechnology company committed to innovation and excellence.
- Benefits: Enjoy competitive salary, health benefits, and flexible work options.
- Why this job: Make a real impact in clinical development while working with cutting-edge technology.
- Qualifications: Bachelor's degree and 8 years of experience in the biotech/pharma industry required.
- Other info: Inclusive culture with excellent career growth opportunities and comprehensive benefits.
The predicted salary is between 100000 - 160000 £ per year.
The Senior Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or complex trials or program level 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 Senior Manager, Central Monitoring will be responsible for supporting a number of studies within a therapy area and program-level. They will work closely with other Central Monitors to ensure effective identification, conduct and reporting of central monitoring activities in support of sponsor oversight obligations. The role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities.
A typical day in this role looks like:
- Central Monitoring Reviews
- Responsible for development and authoring activities of the Central Monitoring Plan
- Participate in the Quality Risk and Control Tracker (QRACT) development
- Present at the CRO kick-off meeting
- Work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies.
- Conduct & Communicate Study-level and Program-Level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools
- Interpret the relationships between each Key Performance Indicator/metric and any supporting data to critically assess trends within a site/study
- Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralized monitoring activities and/or investigator sites potentially requiring sponsor intervention
- Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions
- Document the output from the Central Monitoring Review meetings and track decisions/actions to closure
- Access, review and complete applicable tracking and reporting tools when necessary eg. CTMS/ODR/etc.
- Define strategies, interpret data, and provide insights for Central Monitoring under the Risk-Based Quality Management (RBQM) operating model at functional and partnership levels.
- Present at periodic study and program-level Quality Risk Review meetings with the study team
- Act as a subject matter expert for the implementation and execution of Central Monitoring within the study teams
- Represent Central Monitoring with audit and inspection preparation and conduct if applicable
- Partner with outsourcing management and counterparts at CROs to align on monitoring and central monitoring strategy, standards, risk based monitoring strategy, and input into the central monitoring documents
- Provide oversight of CRO partner central monitoring activities ensuring the CRO is executing per the Partnership Operations Manual
- Critically evaluate the availability, quality and output of integrated data, metrics and reports to ensure they continue to meet the needs in support of the Central Monitoring review processes
- Represent Central Monitoring in process improvement initiatives, and participate in functional strategic planning
- Assess and evaluate the Central Monitoring Process including sensitivity of detection methods, availability of new technologies, required enhancements to process to further refine where necessary
- Assign and delegate appropriate tasks to Central Monitoring Associate Manager & Central Monitoring Managers
- Tasks include and are not limited to: raising/setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports.
This role may require 25% travel.
This role may be for you if you have:
- Proficiency and experience with CluePoint or similar RQBM system for Central Monitoring
- Problem solving abilities, troubleshooting and resourcefulness
- Analytical problem-solving experience
- Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations
- Effective communication and interpersonal skills; ability to build relationships internally and externally
- Understands current and possible future business trends and information
- Demonstrates writing skills to deliver messages effectively so messages are clearly understood
- Proficiency in Microsoft Office applications
In order to be considered qualified for this role, a minimum of a Bachelor’s degree is required and at least 8 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct Central Monitoring experience. Site monitoring or data management experience is a plus.
Senior Manager Central Monitoring employer: Regeneron Pharmaceuticals, Inc.
Contact Detail:
Regeneron Pharmaceuticals, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Central Monitoring
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Manager role.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your experience in central monitoring. We want you to show them that you’re not just a fit for the role, but for the team too!
✨Tip Number 3
Practice your storytelling skills! Be ready to share specific examples of your past experiences, especially those that highlight your analytical problem-solving abilities and leadership in central monitoring. We want you to shine and make a memorable impression!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us. Let’s get you on board!
We think you need these skills to ace Senior Manager Central Monitoring
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Manager, Central Monitoring role. Highlight your experience with Key Risk Indicators and any relevant analytical tools you've used. We want to see how your skills align with what we're looking for!
Showcase Your Experience: Don’t just list your previous jobs; tell us about your achievements! Focus on your direct Central Monitoring experience and how you've contributed to process improvements in past roles. We love seeing real examples of your impact.
Be Clear and Concise: When writing your application, clarity is key. Use straightforward language and avoid jargon unless it’s relevant to the role. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Regeneron Pharmaceuticals, Inc.
✨Know Your Data
As a Senior Manager in Central Monitoring, you'll be dealing with Key Risk Indicators and Key Performance Indicators. Brush up on your data analysis skills and be prepared to discuss how you interpret these metrics. Familiarise yourself with CluePoint or similar systems, as this will show your technical proficiency.
✨Showcase Your Problem-Solving Skills
This role requires strong analytical problem-solving abilities. Think of specific examples from your past experience where you've successfully identified issues and implemented solutions. Be ready to share these stories during the interview to demonstrate your resourcefulness.
✨Communicate Effectively
Effective communication is key in this position. Practice articulating complex ideas clearly and concisely. You might even want to prepare a brief presentation on a relevant topic to showcase your ability to convey information effectively, just like you would in a Quality Risk Review meeting.
✨Understand the Bigger Picture
Familiarise yourself with the clinical drug development process and current industry trends. Being able to discuss how central monitoring fits into the overall strategy of clinical studies will impress your interviewers and show that you're not just focused on the details but also understand the broader context.
