Manager – Central Monitor, Data Surveillance (Clinical Data Sciences)
Location: Chennai, Tamil Nadu, India
Employment Type: Full Time
Work Mode: Hybrid
Job Requisition ID: 4950343
Industry: Clinical Research | Clinical Data Sciences | Risk-Based Monitoring
Pfizer is seeking a Manager, Central Monitor, Data Surveillance to join its Clinical Data Sciences (CDS) group, a core delivery function within Clinical Development & Operations (CD&O). This role is responsible for delivering high-quality, timely risk-based monitoring (RBM) analytics across Pfizer’s global clinical trial portfolio.
The position supports a modern clinical monitoring model that leverages centralized data, site-level insights, and advanced analytics to focus monitoring efforts on risks with the highest potential impact on patient safety, data integrity, and regulatory compliance.
Implement global RBM strategies, standards, and processes to ensure consistent, efficient, and high-quality study delivery
Provide subject matter expertise for study-level setup, testing, and execution of RBM systems
Review RBM system outputs to identify signals and support structured signal and action management
Develop and execute communication plans to ensure stakeholder alignment and continuous study-level improvements
Resolve conflicts and influence cross-functional stakeholders through effective communication and collaboration
Configure and validate study-level RBM systems to ensure system quality and regulatory compliance
Define and maintain Key Risk Indicators (KRIs), ensuring alignment between study-level and enterprise standards
Ensure RBM systems align with clinical protocols, ICH-GCP guidelines, SOPs, corporate standards, and regulatory requirements
Perform centralized data surveillance activities, including review of RBM outputs and risk signals
Collaborate with study teams to define issue resolution pathways for identified signals and actions
Develop and maintain quality control documentation to ensure data completeness, accuracy, and audit readiness
Partner with Clinical Data Scientists to ensure signals are mitigated, actions are completed, and RBM systems are appropriately released
Work closely with Clinical Data Scientists (CDS) at the study level to deliver RBM outputs
Collaborate with cross-functional study team members to support monitoring, risk mitigation, and study execution
Bachelor’s degree or higher in a scientific, clinical, or business-related discipline
8–12 years of relevant experience supporting clinical trials in areas such as clinical data management, centralized monitoring, site monitoring, or clinical operations
Strong understanding of clinical study management, data management, and regulatory operations
Demonstrated experience supporting or implementing risk-based monitoring (RBM) frameworks
Proven project management skills with the ability to manage multiple priorities independently
Excellent verbal and written communication skills with the ability to influence internal and external stakeholders globally
Working knowledge of clinical development across Phase I–IV and principles of study design
Prior experience in clinical data management, including CRF design, database setup, edit check specifications, DMPs, and data cleaning
Experience with clinical trial databases and centralized monitoring platforms
Technical exposure to Oracle, PL/SQL, SAS, Java, and relational database design
Understanding of basic statistical concepts and data analytics principles
Proficiency in Windows-based applications including Word, Excel, PowerPoint, and Project
Pfizer offers the opportunity to work at the forefront of clinical research, supporting global programs that directly impact patient safety and data quality. Employees benefit from a collaborative, science-driven culture, exposure to innovative clinical technologies, and structured career growth within a globally recognized biopharmaceutical organization.
Gujarat :
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