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Risk Management Lead

1 month ago

San Mateo, California, United States BeiGene Full time
Job Summary:

The Risk Based Quality Management Lead will be responsible for creating risk assessments for entities in clinical development, following up on quality signals, issues, and open actions, and contributing to the advancement of the RBQM program.

Key Responsibilities:

• Provide assigned teams with onboarding training and tools to aid in the adoption of RBQM

• Facilitate risk management with relevant stakeholders for identification of critical to quality factors, and identification, evaluation, control, communication, review, and reporting of risks

• Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, process owners, and others as needed to analyze risks and issues using quality performance data, to identify follow-up actions, and to oversee completion of identified actions

• Draft, maintain, and archive the documentation of risk management activities, e.g., risk/issue(s), controls, findings, escalations, tracking, and resolution, utilizing RBQM tools and following BeiGene SOPs

• Trend risks and issues across related entities

• Support the study team and other contributors to clinical development in optimization of controls applied based on risk evaluation, for example, optimizing the application of source data verification and source document review

• Support the study team in optimizing the RBQM model, including acting as a change champion and subject matter expert for a risk-based environment

• Develop and lead culture change and communication activities with stakeholders

• Conduct ad hoc risk assessments as needed to support clinical development

Requirements:

• 8+ years leading risk assessments in the pharmaceutical industry or equivalent

• Prior experience deploying risk-based quality management programs across clinical development preferred

• Ability to work independently to complete management and oversight activities

• Experience working and communicating within cross-functional teams

• Knowledge of overall clinical trial management process, understanding of the protocol, and other clinical trial-related plans and documents

• Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data

• Therapeutic area-specific experience and knowledge – Oncology/Hematology preferred

• Ability to use the relevant technology and risk-based tools/platforms effectively

• Proven track record in delivering agreed results against a plan and timeline

• Understanding of ICH and regulatory environment

• Problem-solving skills

• Self-management skills

• Ability to work in a global team environment

Education:

Bachelor's in Business or Science-related field

Masters in Business or Science-related field