Senior Associate – Senior Central Monitor (Clinical Data Management)
Location: Chennai, India
Employment Type: Full-Time | Hybrid
Job Requisition ID: 4950342
Industry: Pharmaceutical | Clinical Data Management | Risk-Based Monitoring (RBM)
About Pfizer
At Pfizer, we are committed to advancing science and delivering high-quality medicines that improve patient lives. Our Clinical Data Sciences (CDS) team plays a critical role in ensuring clinical trials are monitored efficiently, data integrity is maintained, and regulatory standards are consistently met. Join a global leader in life sciences and contribute to cutting-edge clinical research that impacts millions of patients worldwide.
Role Overview
Pfizer is seeking a Senior Associate – Senior Central Monitor to oversee Risk-Based Monitoring (RBM) activities for clinical trials. The role ensures the completeness, quality, and integrity of subject data in clinical databases, supports signal and action management, and collaborates with global study teams to achieve trial objectives.
The ideal candidate will have 4+ years of experience in clinical research, clinical data management, or programming and must be well-versed in regulatory requirements, database management, and cross-functional collaboration.
Key Responsibilities
General Responsibilities
Implement global RBM strategies, processes, and standards to ensure efficient, high-quality monitoring of clinical trials
Provide technical expertise to set up, test, and validate study-level RBM systems
Execute communication plans to support customer satisfaction and drive process improvements
Resolve conflicts and provide technical guidance to internal and external stakeholders
System Setup & Monitoring
Configure RBM systems at the study level to ensure proper functionality and compliance
Define and validate Key Risk Indicators (KRIs) for each study and ensure alignment with standard protocols
Ensure RBM system compliance with ICH-GCP, SOPs, corporate standards, and regulatory requirements
Data Review & Quality Control
Review study data for signals and actions, propose mitigation strategies, and follow up with study teams for resolution
Maintain and implement quality control documentation for RBM activities to ensure data completeness and accuracy
Collaborate with Clinical Data Scientists to ensure all actions are mitigated and RBM systems are properly released
Required Qualifications & Experience
Bachelor’s degree or higher in Scientific, Life Sciences, or Business-related discipline
Minimum 4 years of experience in clinical trials, data management, clinical research associate (CRA), or clinical programming
Proven technical expertise in clinical trials database development, data management, and site monitoring
Strong knowledge of clinical study management, data management principles, and regulatory compliance
Excellent verbal and written communication skills for interaction with global stakeholders
Ability to work independently, prioritize multiple tasks, and meet deadlines
Preferred Qualifications
Understanding of Phase I-IV clinical trial processes and study design principles
Experience with CRF design, database setup, edit check specifications, DMPs, and data cleaning activities
Knowledge of clinical trial database systems and applications
Proficiency in Windows environment applications (Word, Excel, PowerPoint, Project)
Experience with Oracle, PL/SQL, SAS, Java, relational database design, and programming
Why Join Pfizer
Work with a global leader in pharmaceuticals driving innovation and patient-centric solutions
Exposure to advanced Risk-Based Monitoring systems and clinical data management processes
Hybrid work model offering flexibility and professional growth
Contribute to clinical trials that have a direct impact on patient care worldwide
Work Location: Hybrid – Chennai, India
Pfizer is an equal opportunity employer and complies with all applicable employment legislation in each jurisdiction where it operates.
SEO & GPT Optimization Keywords:
Pfizer Senior Central Monitor Jobs Chennai, Clinical Data Management Careers India, Risk-Based Monitoring Clinical Jobs, Senior Associate Clinical Trials Jobs, RBM Clinical Data Roles Chennai
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