Company
RiskSurveillanceLead
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Risk Surveillance Lead. Skills: Risk Surveillance, Risk-Based Quality Management (RBQM), Cross-functional Coordination, Vendor/Stakeholder Management, Operational Metrics, Resource Planning, Continuous Improvement. Driving the adoption of RBQM practice at trial level. Overseeing the implementation and continuous improvement of RBQM”
What You'll Achieve.
Driving the adoption of RBQM practice at trial level; Oversee the implementation, and continuous improvement; Enable a comprehensive clinical quality (GCP) risk governance; Achieve maximum benefit from RBQM methodology
Industry & Context.
Root cause identification; Mitigation strategies; Analyze data, identify patterns and make recommendations for improvement
On site expectation of 12 days per month/ave. 3 days per week in the office.
What They're Looking For.
Must Have
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, 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, 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 interpersonal skills, Supports a culture of continual improvement and promotes knowledge sharing, Ability to influence without authority, Thinks challenges the status quo, English: fluent written and spoken
Nice to Have
Preferred minimum of 1 years of experience in Risk Based Quality Management, Knowledge of RBQM IT systems or other data analytic systems
What You'll Do.
Driving the adoption of RBQM practice at trial level
Overseeing the implementation and continuous improvement of RBQM
Surveillance of quality risks across assigned trials and programs
Facilitating trial protocol risk assessment across multiple cross-functional domains
Defining quality tolerance limits (QTLs)
Evaluating risks based on likelihood
Ensuring mitigation strategies/plans are defined
and archiving study-specific documentation of risk management activities
Partnering with the RBQM system configuration team
Conducting periodic central surveillance of aggregate data
Identifying emerging risks and/or issues
Facilitating risk review meetings and discussions
Supporting and participating in internal and external audits and inspections
Collaborating with training departments to support training initiatives
Identifying and sharing lessons learned
and process improvement opportunities
Acting as a change agent
subject matter expert and point of contact of RBQM methodology
How You'll Work.
Team & Collaboration
Works within a matrix environment; Partners with the RBQM system configuration team; Facilitates risk review meetings and discussions with study and potentially program team members; Collaborates with training departments; Leads study teams to understand and follow best practices
Communication Scope
Fluent written and spoken English; Effectively communicate and discuss findings; Support training initiatives
Process & Methodology
Risk Management, Integrated Quality Risk Management Plan (IQRMP) Drafting
Full Job Description
**Band** Level 5 **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. #LI-Hybrid On site expectation of 12 days per month/ave. 3 days per week 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 av
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