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 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
- 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
Recommended Jobs
Corporate Account Executive
Corporate Account Executive Occupation Code 3552 Location London Roles & Responsibilities Enhance the profile of the client brand across the UK. Research new distribution opportunities…
Risk Analyst Higher Apprenticeship Programme 2026 London
Risk Analyst Higher Apprenticeship Programme 2026 London Apprenticeships at Barclays As an apprentice, you’ll join us in real, permanent, well-paid jobs – doing real, challenging work from the …
German speaking Media Sales Consultant - Travel Media
We have a brand-new opportunity to work with a well-known travel media international company, operating all over the world. They are looking for a Bilingual Digital Sales Representative to join their…
Senior Quantity Surveyor / Associate
A global real estate consultancy with over 50,000 employees worldwide is expanding their London cost management team. Known for delivering complex, high-profile commercial, leisure and accommodation s…
Learning Support Assistant
Learning Support Assistant - Chiswick - Full Time - Temp to Perm - MLD - September Start This is a specialist autism school providing education for pupils with Autism and Moderate Learning Difficult…
Business Development Manager
Description Business Development Manager We are looking for a Business Development Manager in our Broker Team. The Business Development Manager role is part of the award winning Introducer Channe…
Corporate & Treasury Operations Officer (CTO)- 6 month FTC
THE COMPANY: Our client is an international banking group based in the City that specialises in project and acquisition finance. THE RESPONSIBILITIES: Setting up Credit Agreements and Fa…
Senior Manager, Finance Transformation - Finance Consulting (Value & Performance Management) UKI
At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and…
Duty Shift Manager - EC3M, London - England
Duty Shift Manager - EC3M, London - England Do you have previous security experience and excellent communication skills? Do you provide exceptional customer service and maintain a professional de…
Senior Prudential and Financial Risk Management Auditor - London
Hello, we’re Starling. We built a new kind of bank because we knew technology had the power to help people save, spend and manage their money in a new and transformative way. We’re a fully licensed U…