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. oversee the implementation, and continuous improvement of RBQM”
Industry & Context.
root cause identification; mitigation strategies; root cause analyses; analyzing data; identifying patterns; making 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
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
oversee the implementation
and continuous improvement of RBQM
surveillance of the quality risks across the assigned trials and program
Facilitate trial protocol risk assessment across multiple cross-functional domains
definition of quality tolerance limits (QTLs)
evaluation of risks based on likelihood
ensures mitigation strategy / plans are defined
and archiving the study specific documentation of risk management activities
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
identify emerging risks and/or issues
Facilitate risk review meetings and discussions with study and potentially program team members
communicate and discuss the findings
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
and process improvement opportunities
promote continuous improvement and consistency with RBQM processes
leading study teams to understand and follow the best practices to achieve maximum benefit
How You'll Work.
Team & Collaboration
works within a matrix environment; Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc. ); Partners with the RBQM system configuration team; Facilitate risk review meetings and discussions with study and potentially program team members; Collaborate with training departments; experience forming cross-functional interpersonal skills
Communication Scope
effectively communicate and discuss the findings
Process & Methodology
risk management, Integrated Quality Risk Management Plan (IQRMP)
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
Applying for this Risk Surveillance Lead role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.