Location - Must be based in the UK, Spain or Ireland (remote)

Sponsor dedicated 

As a Clinical Risk Surveillance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Working fully embedded within a growing, global program, you will be responsible for 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 accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance.

What you will be doing:
 

• 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), evalua-tion 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
• Partners with the RBQM system configuration team to ensure risk indicators, quality tol-erance limits and other analytics/visualizations are programmed and functioning per op-erational 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 emerg-ing 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 inspection
• Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.

You are:

• Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience

• Minimum of 6 years of experience in the pharmaceutical or CRO industry

• Minimum of 2 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