At a Glance
- Tasks: Oversee clinical trials, ensuring data quality and identifying risks through central monitoring.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for personal growth.
- Other info: Be part of a diverse team dedicated to transforming lives through science.
- Why this job: Make a real impact on patient safety and data integrity in clinical research.
- Qualifications: 5+ years in pharma with strong clinical trial and risk management experience.
The predicted salary is between 42000 - 84000 £ per year.
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, escalate 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. Participate in study team meetings as CTT member and provide data-driven recommendations. 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.
Education: University degree in life science, business or operations.
Experience: ≥ 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 and the management of clinical trials. Specific central monitoring / monitoring experience are strongly preferred. ≥ 3 years comprehensive experience in monitoring (central, site), additional experience in clinical data analytics, data management activities or equivalent is preferable. 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, recognize patterns, and identify potential risk signals or issues.
Commitment To Diversity And Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Central Monitor 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 be part of a mission that not only values your contributions but also empowers you to make a meaningful impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Central Monitor
✨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 land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their values. We recommend practising common interview questions and tailoring your answers to highlight your experience in clinical trials and risk management. Show them you’re the perfect fit!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to remind them why you’re the right choice for the Central Monitor role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Central Monitor
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Central Monitor role. Highlight your experience in clinical trials, risk management, and data analytics. 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 the role involves a lot of data surveillance and risk identification, make sure to showcase your analytical skills. Provide examples of how you've used data to drive decisions or improve processes in your previous roles.
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 love seeing applications come directly from our site!
How to prepare for a job interview at Novartis
✨Know Your Data
As a Central Monitor, you'll be dealing with data surveillance and risk management. Brush up on your understanding of clinical trial data, key risk indicators (KRIs), and how to interpret complex data patterns. Be ready to discuss specific examples from your experience where you identified risks or trends.
✨Showcase Your Collaboration Skills
This role requires working closely with cross-functional teams. Prepare to share instances where you've successfully collaborated with different stakeholders, like Data Analysts or Clinical Trial Teams. Highlight how your communication skills helped in achieving common goals.
✨Understand Regulatory Requirements
Familiarise yourself with Good Clinical Practice (GCP) guidelines and other regulatory requirements relevant to clinical trials. Be prepared to discuss how you ensure compliance in your previous roles and how you would apply that knowledge in this position.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in monitoring activities and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
