Risk Surveillance Lead
Risk Surveillance Lead
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Job Description
Job Description Summary
More than 100000 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
Bachelors 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 peoples 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: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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: Desired
Budget Management Clinical Research Clinical Trial Protocol Clinical Trials Coaching Cross-Functional Teams Data Analysis Learning Design Lifesciences Risk Management Risk MonitoringEmployment Type
Full-Time
Key Skills
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