At a Glance
- Tasks: Lead risk surveillance for clinical trials and drive quality management improvements.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Work in a dynamic environment with a focus on continuous improvement.
- Why this job: Make a real impact on clinical trial quality and patient outcomes.
- Qualifications: Bachelor's degree in life sciences and 4+ years in pharma or CRO.
The predicted salary is between 36000 - 60000 £ per year.
The Risk-Based Quality Management (RBQM) Risk Surveillance Lead is responsible for driving the adoption of RBQM practice at trial level and overseeing the implementation and continuous improvement. The Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance.
Summary
The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles. This role can be based in our offices in Dublin, Ireland, or Barcelona, Spain. On-site expectation of three days in the office.
About The Role
- Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory, etc.) associated with critical-to-quality (CtQ) data and processes.
- Responsible for drafting, maintaining, and archiving the study-specific documentation of risk management activities.
- Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system.
- Conduct periodic central surveillance of the aggregate data at the study and potentially program level.
- Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings.
- Support and participate in internal and external audits and inspections.
- Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
- Identify and share lessons learned, best practices, successes, case studies, failures, and process improvement opportunities.
- Act as a change agent, champion, subject matter expert, and point of contact of RBQM methodology.
Experience
- Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience.
- Minimum of 4 years of experience in the pharmaceutical or CRO industry.
- Preferred minimum of 1 year of experience in Risk-Based Quality Management.
- Robust understanding of the drug development process and clinical trial execution.
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP).
- Experience in risk management, sponsor audits, and health authority inspections.
- Knowledge of RBQM IT systems or other data analytic systems.
- Demonstrated ability to analyze data, identify patterns, and make recommendations for improvement.
- Demonstrated ability to effectively lead cross-functional team meetings.
- Experience forming cross-functional collaborations; strong interpersonal skills.
- Supports a culture of continual improvement and innovation; promotes knowledge sharing.
- Ability to influence without authority.
- Thinks creatively; challenges the status quo.
Languages
- English: fluent written and spoken.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.
Risk Surveillance Lead employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
StudySmarter Expert Advice🤫
We think this is how you could land Risk Surveillance Lead
✨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 help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching Novartis and understanding their values and culture. We recommend practising common interview questions and tailoring your responses to highlight your experience in risk management and clinical trials. Show them you’re the perfect fit!
✨Tip Number 3
Follow up after your interviews! A simple thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role and the company.
✨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 often have exclusive roles listed there that you won’t find anywhere else. Let’s get you that Risk Surveillance Lead position!
We think you need these skills to ace Risk Surveillance Lead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Risk Surveillance Lead role. Highlight your experience in risk management and clinical trials, and don’t forget to mention any relevant skills that match the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the role. Share specific examples of how you've influenced clinical trial quality and your understanding of RBQM practices.
Showcase Your Leadership Skills:Since this role involves leading cross-functional teams, make sure to highlight your leadership experiences. Talk about times when you’ve successfully led meetings or influenced others without authority.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get you on our radar!
How to prepare for a job interview at Novartis
✨Know Your RBQM Inside Out
Make sure you have a solid grasp of Risk-Based Quality Management principles. Familiarise yourself with the specific practices and methodologies that Novartis employs, as well as any recent developments in the field. This will not only show your expertise but also your genuine interest in the role.
✨Prepare for Cross-Functional Discussions
Since the role involves collaboration across various domains, think about how you can effectively communicate with different teams. Prepare examples from your past experiences where you successfully led cross-functional meetings or resolved conflicts. This will demonstrate your leadership skills and ability to influence without authority.
✨Showcase Your Analytical Skills
Be ready to discuss how you've used data analysis to identify risks and improve processes in previous roles. Bring specific examples of how your recommendations led to tangible improvements. This will highlight your capability to analyse data and make informed decisions, which is crucial for the Risk Surveillance Lead position.
✨Emphasise Continuous Improvement
Novartis values a culture of continual improvement, so be prepared to share your thoughts on how you’ve contributed to process enhancements in the past. Discuss any lessons learned or best practices you've implemented, and how they could apply to the role you're interviewing for.
