Manager – Central Monitor, Data Surveillance, Clinical Data Sciences
Location: Chennai, India
Employment Type: Full-Time
Posted: 21 Days Ago
Job Requisition ID: 4950343
Role Summary:
Pfizer’s Clinical Data Sciences (CDS) group, a key unit within Clinical Development & Operations (CD&O), is seeking a Manager, Central Monitor – Data Surveillance to lead risk-based monitoring (RBM) analytics across its clinical trial portfolio. This role focuses on leveraging site-level and clinical data to guide on-site, remote, and centralized monitoring activities, prioritizing risks that most impact patient safety and data quality.
Key Responsibilities:
Global Strategy & Operations
Implement and standardize global RBM strategies, initiatives, and processes to ensure efficiency, consistency, and high-quality deliverables.
Provide technical expertise to set up and validate study-level RBM systems.
Review system outputs and manage signal identification and action plans.
Develop and execute communication plans to enhance stakeholder satisfaction and implement improvements during studies.
Resolve conflicts, influence cross-functional teams, and communicate effectively with key stakeholders globally.
System Setup & Configuration
Configure and test RBM systems at the study level to maintain system quality and reliability.
Define Key Risk Indicators (KRIs) and ensure alignment between global standards and study-specific requirements.
Ensure system compliance with protocols, ICH GCP, SOPs, corporate standards, and regulatory requirements.
Data Review & Quality Oversight
Collaborate with study teams to resolve issues identified as signals or actions.
Develop and maintain quality control documentation for RBM activities to ensure data completeness and accuracy.
Conduct central monitoring activities, review outputs, propose action plans, and follow up with study teams for resolution.
Partner with Clinical Data Scientists to ensure proper mitigation of risks and successful system releases.
Stakeholder Engagement
Coordinate with Clinical Data Scientists and study team members to deliver timely, accurate outputs.
Maintain effective communication with internal and external stakeholders across global sites.
Required Qualifications
Bachelor’s degree or higher in a scientific or business-related discipline.
Technical expertise and hands-on experience supporting clinical trials, database development, data management, and site monitoring.
Strong understanding of clinical study management, data management, and regulatory operations.
Project management experience with the ability to prioritize multiple tasks and work independently.
Excellent verbal and written communication skills for global collaboration.
Preferred Qualifications
Knowledge of clinical development processes, Phase I-IV studies, and study design principles.
Experience in data management, including CRF design, database setup, edit check specification, DMPs, and data cleaning.
Familiarity with clinical trial databases and applications.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project) and database programming (Oracle, PL/SQL, SAS, Java).
Basic understanding of statistical principles.
Experience Required
Minimum 5–7 years of experience in clinical trials, data management, or central monitoring roles.
Hands-on experience with risk-based monitoring (RBM) systems, clinical trial databases, and site monitoring operations.
Proven ability to lead cross-functional teams, coordinate with stakeholders, and deliver high-quality clinical data outputs.
Work Arrangement
Hybrid model with flexibility for on-site and remote collaboration.
Why Pfizer
Pfizer is an equal opportunity employer, committed to diversity and inclusion worldwide. Join our team to advance clinical research while ensuring patient safety, high-quality data, and operational excellence.
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