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Risk Management Lead, Associate Director
2 meses atrás
About the Role:
BeiGene is seeking a highly motivated and experienced Risk Management Lead, Associate Director to join our team. As a key member of our quality management team, you will be responsible for providing onboarding training and tools to assigned teams, facilitating risk management with stakeholders, and collaborating with cross-functional teams to analyze risks and issues.
Key Responsibilities:
- Provides onboarding training and tools to assigned teams to aid in the adoption of risk-based quality management (RBQM) practices.
- Facilitates risk management with relevant stakeholders to identify critical to quality factors, and identify, evaluate, control, communicate, review, and report risks.
- Collaborates with clinical research associates (CRAs), central statistical monitors, data management, vendors, process owners, and others as needed to analyze risks and issues using quality performance data, identify follow-up actions, and oversee completion of identified actions.
- Drafts, maintains, and archives documentation of risk management activities, including risk/issue(s), controls, findings, escalations, tracking, and resolution using RBQM tools and following BeiGene standard operating procedures (SOPs).
- Trends risks and issues across related entities.
- Supports the study team and other contributors to clinical development in optimization of controls applied based on risk evaluation.
- Supports the study team in optimizing the RBQM model, including acting as a change champion and subject matter expert for a risk-based environment.
- Develops and leads culture change and communication activities with stakeholders.
- Conducts ad hoc risk assessments as needed to support clinical development.
- Continued support of business goals.
Requirements:
- 8+ years of experience 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 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.
About BeiGene:
BeiGene is a global biotechnology company that is committed to developing innovative medicines to improve the lives of patients with cancer and other serious diseases. We are proud to be an equal opportunity employer and value diversity.
