• Implement global Risk-Based Monitoring (RBM) strategies, processes, and quality standards across clinical trials
• Ensure full compliance with ICH-GCP guidelines, internal SOPs, and regulatory requirements
• Collaborate with global study teams and stakeholders to meet study timelines and objectives
• Provide technical expertise and clear, customer-focused communication within cross-functional teams
• Configure, test, and maintain study-level RBM systems
• Define, monitor, and manage Key Risk Indicators (KRIs)
• Ensure RBM system alignment with study protocols and regulatory expectations
• Perform centralized monitoring to assess data quality, completeness, and accuracy
• Review RBM system outputs for signal detection and action management
• Support issue resolution and follow up with clinical and data management teams
• Maintain quality control documentation related to RBM activities
• Partner with Clinical Data Scientists to mitigate risks and support RBM system releases
• Bachelor’s degree or higher in Life Sciences, Pharmacy, Clinical Research, or a related discipline
• Minimum of 4 years of experience in clinical trials, such as CRA, Clinical Data Management, Programming, or Central Monitoring roles
• Strong understanding of clinical trial monitoring, RBM frameworks, and regulatory processes
• Knowledge of Phase I–IV clinical development and study design principles
• Experience with clinical trial data review, CRF design, database setup, and data cleaning
• Familiarity with RBM tools and clinical trial databases
• Technical exposure to Oracle, PL/SQL, SAS, Java, or relational databases
• Proficiency in MS Office tools including Excel, Word, PowerPoint, and Project
• Strong communication, analytical, and problem-solving skills
• Ability to work independently and manage multiple priorities
Pfizer is a global biopharmaceutical leader dedicated to discovering, developing, and delivering innovative medicines and vaccines that improve health worldwide. With a strong commitment to scientific excellence, patient safety, and regulatory compliance, Pfizer operates across the full spectrum of clinical development, offering professionals meaningful career growth and exposure to global clinical research programs.
Unlock refined AI insights.