Risk Surveillance Lead in London

The Risk-Based Quality Management (RBQM) Risk Surveillance Lead is responsible for driving the adoption of RBQM practice at trial level and overseeing the implementation and continuous improvement. The Risk Surveillance Lead works within a matrix environment and has overall accountability 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 is based in our offices in Westworks, London, UK, with an expectation of 12 days a month onsite.

Major Accountabilities:

• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated with 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).
• Partner with the RBJM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBJM system.
• Conduct periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBJM 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.
• Support and participate in internal and external audits and inspections.
• Collaborate with training departments to support training initiatives and aid in the adoption of the RBJM approach.
• Identify and share lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBJM processes.
• Act as a change agent, champion, subject matter expert and point of contact of RBJM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit.

Experience:

• 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 year 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 RBJM 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.
• Think creatively, challenge the status quo.

Languages: English: fluent written and spoken.

Benefits & Rewards:

Expected Annual Base Salary Range for role: £67,900.00 - £126,100.00 GBP Annual. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Commitment to Diversity and Inclusion / EEO:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.