Senior Risk Surveillance Lead
- 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 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/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 inspections
- 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
- May perform line management of other (junior) staff within RBQM Team
- Adoption rate of RBQM across trial portfolio
- Effectiveness in risk identification, assessment, and mitigation (number of risks identified, assessed, and successfully mitigated)
- Stakeholder satisfaction measured through structured feedback and surveys conducted periodically
- Insights generated from metrics leading to Process and Quality Risks improvements
- Minimum of 6 years of experience in the pharmaceutical or CRO industry
- Minimum of 2 years managerial and supervisory experience
- 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
Recommended Jobs
Contracts Manager
As a Contracts Manager, you will be responsible for overseeing multiple construction projects, ensuring they are delivered on time, within budget, and to the highest quality and safety standards. You…
Service Advisor
We are currently advertising on behalf of an Automotive well-established Car Dealership who are currently recruiting for a Service Advisor to assist in their busy Service Department in the Wimbledon a…
Electrician
1)To undertake planned preventative maintenance or emergency work as demanded by a Hospital of this type and use all skills, knowledge to ensure safe methods of working and to carry out maintenance ta…
Bank Catering Assistant
Bank Catering Assistant Haven Residential Care Home, 36-38 Wellington Road, Hatch End, Pinner, Middlesex, HA5 4NL £12.70 per hour Hours as and when required Why work for us? …
Bank Care Team Leader
Bank Care Team Leader Haven Residential Care Home, 36-38 Wellington Road, Hatch End, Pinner, Middlesex, HA5 4NL £15.18 per hour Hours as and when required Why work for us? We…
Chef Manager - Dagenham (school)
Chef Manager - Dagenham (school) We are looking for a Chef Manager to join our amazing catering division to lead a small team in a school in Dagenham to deliver a well-run, large-scale catering oper…
Mechanical Project Manager
Job Title: Mechanical Project Manager Location: Central London Employment Type: Permanent Salary: £80,000 – £85,000 + Travel Allowance + Bonus + Pension About the Role: We are currently…
Quantitative FIC Internship
Quantitative FIC Internship About the program: The Deutsche Bank Internship Program is designed to help you develop your skills through formal training and continuous support. You’ll quickly ga…
Social Media & Marketing Specialist
Social Media & Marketing Specialist Location: London Salary: Market Rate Salary band: Dependant upon experience Contract type: Permanent Date posted: 11th September 2025 Blue Legal are…
Senior Health & Safety Manager - RC Frames & Groundworks - London
Health & Safety Manager RC Frames & Groundworks £50,000 - £75,000 + Package About the Opportunity: We have been asked to source a Health & Safety Manager to work as part of the senior safet…