PHARMAFull time
Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences
By Admin · Clinical Data Management
CHENNAI (IN)HYBRIDPOSTED: 10/30/2026
PHARMAFull time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Pfizer is recruiting a Senior Associate, Central Monitor in Chennai to run risk-based monitoring of subject data in clinical trial databases. The job involves configuring and testing the RBM system at study level, defining key risk indicators and following up on signal and action resolution with global study teams.
ROLE DEFINITION & RESPONSIBILITIES
- •Set up and test the study-level Risk Based Monitoring system to confirm system quality.
- •Define key risk indicators in the study system and align them with standard-level definitions.
- •Configure the data quality assessment dictionary in the study system.
- •Review study-level system outputs and process them for signal and action management.
- •Work with the study team to agree issue resolution for findings reviewed as signals and actions, and follow up until actions are closed.
- •Review protocols to confirm that set-up, review and reporting requirements can be met and are standardised.
- •Implement quality oversight and control steps in central monitoring, and maintain related quality control documentation.
- •Document lessons learned and share them with other central monitors and study teams for cross-study learning.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Familiarity with supported systems such as the RBM system, with the ability to troubleshoot and respond rapidly to database issues.
- Knowledge of ICH GCP, applicable SOPs, corporate standards and regulatory requirements.
- Ability to implement global strategies, initiatives, processes and standards for consistent quality against timelines.
- Ability to provide technical oversight, guidance and coordination for central monitoring activities.
- Ability to plan and execute communication plans, resolve conflicts and influence stakeholders and customers.
- Ability to work with the global study team to meet study objectives.
REQUIRED VERIFIED SKILLS
Risk Based Monitoring (RBM) system set-up and testing
Key risk indicators (KRIs)
Data quality assessment (DQA) dictionary
Signal and action management
ICH GCP
SOP compliance
Protocol review
Quality control documentation
Stakeholder communication
Conflict resolution
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Pfizer is a pharmaceutical company; this position sits within its Clinical Data Sciences function.
TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
APPLICATION ADVISORY
Highlight hands-on work with risk-based monitoring systems, including study-level set-up, testing and key risk indicator configuration, since the role owns those tasks directly. Emphasise your grasp of ICH GCP and SOP-driven quality control documentation, plus examples of following signal and action findings through to closure with study teams and clinical data scientists. Mention any experience communicating with global stakeholders or acting in an oversight capacity, as the posting includes possible service as CM Program Oversight Lead.
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