The Risk Surveillance Lead oversees the implementation and improvement of risk management practices in clinical trials, facilitating risk assessments, documentation, audits, and collaboration across teams.
Job Description Summary
More than 100,000 people across 140 countries are working for Novartis to discover, develop, and successfully market innovative products to prevent and cure diseases, ease suffering, and enhance the quality of life.The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall account-ability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. 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 London, Dublin or Barcelona. On site expectation of three days in the office.
Job Description
Major Accountabilities:
- Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
- Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
- Partners 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 of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues
- Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
- Supports and participates in internal and external audits and inspection
- Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
- Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
- Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
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 years 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, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
- 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? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk MonitoringTop Skills
Data Analytic Systems
Rbqm It Systems
Novartis Dublin, Dublin, IRL Office
203 Merrion Rd, Dublin, Ireland, D04 NN12
Similar Jobs
Biotech • Pharmaceutical
The Risk Surveillance Lead drives Risk-based Quality Management at trial level, overseeing risk assessment, mitigation strategies, and quality governance across clinical trials.
Top Skills:
Data Analytic SystemsRbqm Systems
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
The Workplace Services Site Lead coordinates day-to-day Facilities Management, manages vendors, engages stakeholders, oversees events, and ensures operational efficiency.
Top Skills:
CafmCmmsServicenow
.png)
Artificial Intelligence • Blockchain • Fintech • Financial Services • Cryptocurrency • NFT • Web3
As a TMS Compliance Analyst, you will investigate transaction alerts, draft SARs, analyze AML compliance policies, and maintain documentation for regulatory compliance.
Top Skills:
ChainalysisExcelGoogle DocsGoogle SheetsHummingbirdJIRASalesforce Service CloudWord
What you need to know about the Dublin Tech Scene
From Bono and Oscar Wilde to today's tech leaders, Dublin has always attracted trailblazers, with more than 70,000 people working in the city's expanding digital sector. Continuing its legacy of drawing pioneers, the city is advancing rapidly. Ireland is now ranked as one of the top tech clusters in the region and the number one destination for digital companies, with the highest hiring intention of any region across all sectors.
