Risk Surveillance Lead
About this role
Job Description Summary
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 our offices in London, UK, Dublin, Ireland or Barcelona, Madrid, Spain. Please apply to the relevant job advertisement for your location.
Please note that Novartis cannot sponsor visas for these locations. Relocation is not available for these locations.
Requirements
- 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
- Skills Desired
- Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Assessments, risk based quality management, Risk Management, Risk Mitigation Strategies, Risk Monitoring, Root Cause Identification