At a Glance
- Tasks: Oversee clinical trials, ensuring data quality and identifying potential risks through data analytics.
- Company: Join Novartis, a leader in the pharmaceutical industry with a commitment to innovation.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team dedicated to improving global health outcomes.
- Why this job: Make a real impact on patient safety and data integrity in clinical research.
- Qualifications: 5+ years in pharma, strong analytical skills, and experience in clinical trial management.
The predicted salary is between 60000 - 80000 £ per year.
LOCATION: London, Dublin, Barcelona
ROLE TYPE: Hybrid Working, #LI-Hybrid
The Central Monitor (CM) plays a key role for Data Surveillance by overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk-based monitoring strategies. The CM collaborates with cross-functional teams to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CM will play a vital role in the study Risk-Based Quality Management process.
Job Responsibilities:
- Central Monitoring Execution: Implement and execute centralized monitoring strategies to support clinical trial oversight. Conduct ongoing central monitoring analysis of clinical trial data to detect trends and signals. Work with Data Analysts team in reviewing CM technology outputs and performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with study teams. Ensure adherence to risk-based monitoring plans, SOPs, and industry best practices.
- Risk Identification and Management: Perform data surveillance via the CM platform, identifying potential sites or trial risks in alignment with the IQRMP. Collaborate with Lead CM and study teams to refine and implement risk-based monitoring plans. Provide insights and recommendations to enhance trial efficiency and mitigate risks. Support root cause analysis for identified issues and suggest corrective actions.
- Data Review and Reporting: Generate and summarize findings within the CM platform and lead the communication of results to study teams and RSL. Contribute to GCO understanding of impact of findings to data quality. Support DQT in assessing the criticality and potential root causes of the findings and in defining appropriate follow-up actions. Document findings, elevate critical risks, and support follow-up actions. Ensure timely documentation of monitoring activities and findings.
- Data integrity and quality through Collaboration: Collaborate with cross-functional study teams, including RSLs, Study Leaders, Data Managers, and Clinical Scientific Leaders, to ensure robust risk mitigation plans are in place and effectively executed. Act as a single point of contact for CM activities for relevant stakeholders for allocated studies and ensure timely communication and coordination.
- Protocol and Study Design Support: Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of Central Monitoring efforts.
- Continuous Improvement and Compliance: Support the continuous improvement of centralized monitoring methodologies. Ensure adherence to regulatory requirements, SOPs, and GCP guidelines. Contribute to training and knowledge-sharing initiatives within the Central Monitoring team.
Job Requirements:
- University degree in life science, business or operations.
- ≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs.
- Strong clinical experience with excellent understanding of clinical trial development and risk management processes.
- Specific central monitoring / monitoring experience are strongly preferred.
- Knowledge of Risk-Based Quality Management (RBQM) and adaptive monitoring principles.
- Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.
- Strong analytical and critical thinking skills with the ability to interpret complex clinical and operational data.
- Excellent communication and coordination skills.
- Strong project management skill with demonstrated ability to meet timelines.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Central Monitoring Specialist - Data Surveillance & RBQM employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic hybrid working environment in vibrant cities like London, Dublin, and Barcelona. Our commitment to employee growth is reflected in our robust training programmes and collaborative culture, where diverse teams work together to drive innovation in clinical trials. Join us to make a meaningful impact on patient safety and data quality while enjoying the unique advantages of working in a global pharmaceutical leader dedicated to inclusivity and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Central Monitoring Specialist - Data Surveillance & RBQM
✨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. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values, recent projects, and how they align with your skills. This will help you tailor your responses and show that you're genuinely interested in the position.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience with data surveillance and risk management clearly, as these are key aspects of the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re proactive and serious about joining our team. Good luck!
We think you need these skills to ace Central Monitoring Specialist - Data Surveillance & RBQM
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Central Monitoring Specialist role. Highlight your relevant experience in clinical trials, data surveillance, and risk management. 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 any specific experiences that relate to the job description.
Showcase Your Analytical Skills:Since this role involves a lot of data analysis, make sure to showcase your analytical skills in your application. Provide examples of how you've used data to identify risks or improve processes in previous roles. We love seeing those numbers!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we can’t wait to see what you bring to the table!
How to prepare for a job interview at Novartis
✨Know Your Data
As a Central Monitoring Specialist, you'll be dealing with data surveillance and risk management. Brush up on your knowledge of clinical trial data analytics and risk-based monitoring strategies. Be prepared to discuss how you've used data to identify trends and signals in past roles.
✨Understand the Role
Make sure you fully grasp the responsibilities outlined in the job description. Familiarise yourself with concepts like Key Risk Indicators (KRIs) and Good Clinical Practice (GCP). This will help you articulate how your experience aligns with the role during the interview.
✨Showcase Collaboration Skills
This role requires working closely with cross-functional teams. Prepare examples of how you've successfully collaborated with different stakeholders in previous positions. Highlight your communication skills and ability to coordinate effectively across teams.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think of specific instances where you've identified risks or issues in clinical trials and how you addressed them. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
