Senior Associate – Senior Central Monitor
Location: Chennai, Tamil Nadu, India
Category: Medical / Clinical Operations
Job Type: Full Time
Job ID: 4950342
Company Overview
Pfizer is a global leader in biopharmaceuticals, advancing innovations to improve patient lives worldwide. Our Clinical R&D teams leverage cutting-edge technology and processes to ensure high-quality, compliant, and efficient clinical trials. At Pfizer, you will be part of a collaborative, inclusive environment where expertise and innovation are valued to drive healthcare forward.
Role Summary
The Senior Central Monitor is responsible for ensuring the completeness, quality, and integrity of clinical trial data within Risk-Based Monitoring (RBM) systems. The role focuses on implementing, managing, and reviewing RBM activities to identify key risk indicators (KRIs), monitor signals, and ensure timely issue resolution. The Senior Central Monitor collaborates with global study teams, providing technical expertise to support study objectives and regulatory compliance.
Key Responsibilities
General Responsibilities:
Implement global RBM strategies, standards, and processes to ensure data quality, regulatory compliance, and study timelines.
Provide technical expertise to configure and test study-level RBM systems.
Review system outputs to monitor signals and manage follow-up actions.
Execute communication plans to ensure stakeholder satisfaction and implement improvements during study execution.
Resolve system conflicts and provide guidance to internal and external stakeholders.
System Setup Functions:
Configure and validate RBM systems at study level to ensure data integrity and compliance.
Define and implement key risk indicators (KRIs) aligned with study protocols, SOPs, ICH-GCP, and corporate standards.
Ensure consistency between standard-level and study-level RBM configurations.
Data Review Functions:
Support the resolution of data review findings and signal/action management.
Maintain RBM quality control documentation to ensure completeness and accuracy.
Conduct central monitoring activities, review system outputs, and collaborate with study teams to resolve actions.
Coordinate with Clinical Data Scientists to validate proper mitigation of signals and release of RBM systems.
Minimum Qualifications:
Bachelor’s degree or higher in a scientific or business-related discipline.
At least 4 years of clinical trial experience (CRA, Data Management, Programmer, or related roles).
Technical expertise in clinical trial database development, data management, and site monitoring.
Understanding of clinical study processes, data management, and regulatory operations.
Strong verbal and written communication skills for global collaboration.
Ability to work independently, manage multiple tasks, and organize priorities efficiently.
Preferred Qualifications:
Knowledge of clinical development processes, Phase I-IV studies, and study design principles.
Previous experience in data management, including CRF design, database setup, edit checks, DMPs, and data cleaning activities.
Experience with clinical trial databases and applications.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project) and familiarity with Windows environment.
Skills in Oracle, PL/SQL, SAS, Java, relational database design, and programming.
Work Model: Hybrid (Chennai, Tamil Nadu, India)
Experience Required: Minimum 4+ years in clinical operations, data management, or related roles within pharmaceutical/biotech industry.
About Pfizer
Pfizer is committed to innovation and excellence in healthcare. Our global teams collaborate to ensure compliance, high-quality data, and effective delivery of clinical trial programs. Join Pfizer to advance your career in a dynamic, inclusive, and impactful environment.
Equal Opportunity Employer: Pfizer provides equal employment opportunities and complies with all applicable legislation in every jurisdiction in which it operates.
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