Manager – Central Monitor, Data Surveillance, Clinical Data Sciences
Location: Chennai, India
Employment Type: Full-Time | Hybrid
Job Requisition ID: 4950343
Industry: Pharmaceutical | Clinical Data Management | Risk-Based Monitoring (RBM)
About Pfizer
Pfizer is a global leader in pharmaceuticals dedicated to improving patient health through innovative therapies. The Clinical Data Sciences (CDS) team, within Clinical Development & Operations (CD&O), ensures clinical trial data integrity, patient safety, and compliance through advanced risk-based monitoring (RBM) approaches. Join Pfizer and contribute to clinical trials that make a global impact on healthcare.
Role Summary
The Manager – Central Monitor, Data Surveillance will lead the execution of risk-based monitoring analytics for Pfizer’s clinical trial portfolio. This role ensures that data collected across multiple studies is complete, accurate, and monitored for patient safety and study quality. The Manager will leverage site-level and trial-level data to determine monitoring strategies—on-site, remote, or centralized—and focus resources on the areas of highest risk.
Experience Required: Minimum 6–8 years in clinical research, data management, clinical trial monitoring, or related roles, including experience with RBM systems and team coordination.
Key Responsibilities
General Responsibilities
Implement global RBM strategies, processes, and standards to ensure high-quality, consistent clinical monitoring
Set up and validate study-level RBM systems
Review system outputs to identify signals and drive action management
Plan and execute communication strategies to ensure study team alignment and customer satisfaction
Resolve conflicts and collaborate cross-functionally with global stakeholders
System Setup & Configuration
Configure RBM systems at the study level, ensuring system quality and compliance
Define Key Risk Indicators (KRIs) and maintain alignment between standard and study-specific requirements
Ensure compliance with ICH-GCP, SOPs, corporate standards, and regulatory requirements
Data Review & Central Monitoring
Support issue resolution by analyzing findings as signals and actions
Develop and maintain Quality Control documentation for RBM activities to ensure data completeness and accuracy
Perform central monitoring activities, propose corrective actions, and follow up with study teams
Collaborate with Clinical Data Scientists to ensure all signals and actions are properly mitigated and RBM systems are released on schedule
Organizational Interaction
Serve as the primary interface with Clinical Data Scientists and other study team members for deliverables
Provide leadership and guidance to study teams on RBM processes and data monitoring
Required Qualifications
Bachelor’s degree or higher in a scientific or business-related discipline
Strong technical expertise in clinical trials, database development, site monitoring, and data management
Comprehensive understanding of clinical study management, regulatory operations, and RBM principles
Demonstrated project management skills and ability to manage multiple priorities in a fast-paced environment
Excellent verbal and written communication skills for global stakeholder interactions
Proven ability to work independently and make decisions in complex situations
Preferred Qualifications
Knowledge of clinical development processes, including Phase I–IV studies and study design principles
Experience in data management tasks, including CRF design, database setup, edit check specifications, DMPs, and data cleaning
Proficiency in clinical trial databases and related software
Technical experience in Oracle, PL/SQL, SAS, Java, relational database design, and database programming
Familiarity with Windows applications (Word, Excel, PowerPoint, Project)
Understanding of basic statistical principles
Why Join Pfizer
Lead risk-based monitoring initiatives for global clinical trials
Work in a hybrid environment with exposure to cutting-edge clinical data systems
Collaborate with a global clinical development team impacting patient care worldwide
Competitive compensation and opportunities for professional growth in a world-class organization
Work Location: Hybrid – Chennai, India
Pfizer is an equal opportunity employer, committed to diversity, equity, and inclusion, and complies with all applicable employment legislation in every jurisdiction.
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