Risk Based Quality Management Lead - Associate Director

September 16

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501 - 1000

Description

• The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development • Follow up on quality signals, issues and open actions • Contribute to the advancement of the RBQM program • Provides assigned teams with onboarding training and tools to aid in the adoption of RBQM • Facilitates risk management with the relevant stakeholders for identification of critical to quality factors • Identify, evaluate, control, communicate, review and report risks • Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, process owners and others as needed to analyze risks and issues • Draft, maintain, and archive documentation of risk management activities • 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 • Develops and leads culture change and communication activities with stakeholders

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 global team environment

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness