Analyst II, Analytical Monitor – Hyderabad / Mumbai / Bangalore (Hybrid)
Job ID: R-059656
Function: Data Analytics & Computational Sciences
Sub-Function: Clinical Data Management
Category: Experienced Analyst (P5)
Location: Hyderabad / Bangalore / Mumbai, India
Work Pattern: Hybrid
Company: Johnson & Johnson
About the Company
Johnson & Johnson is a global leader in healthcare innovation, committed to advancing patient outcomes through Innovative Medicine and MedTech solutions. Guided by a strong ethical foundation and a culture of inclusion, the organization focuses on delivering breakthrough therapies, smarter treatments, and data-driven healthcare solutions that impact lives worldwide.
Role Overview
The Analyst II, Analytical Monitor is an experienced individual contributor responsible for executing Analytical Risk-Based Monitoring (ARBM) activities across multiple clinical trials. This role leverages advanced data analytics, technology platforms, and centralized monitoring strategies to detect risks, enhance data integrity, and improve site performance.
The position works closely with Site Managers, Central Monitoring Managers, Clinical Data Management teams, and cross-functional stakeholders to ensure compliance with regulatory standards and internal SOPs while driving high-quality clinical trial execution.
Key Responsibilities
Clinical Trial Monitoring & Data Analytics
Perform analytical monitoring activities across assigned clinical studies in alignment with portfolio timelines.
Conduct structured site-level and subject-level reviews to identify trends, early warning signals, and data quality risks.
Support risk mitigation strategies to prevent recurrence of identified issues.
Provide actionable data insights to support site prioritization and engagement strategies.
Risk-Based Monitoring (RBM) Execution
Identify potential risks related to patient safety, protocol compliance, and data reliability through analysis of clinical systems and reporting tools.
Collaborate with Site Managers and Central Monitoring Managers to address detected trends and signals.
Support end-to-end monitoring processes, including study execution and close-out activities.
Process Compliance & Continuous Improvement
Ensure compliance with SOPs, regulatory requirements, and industry guidelines including ICH-GCP.
Contribute to process improvement initiatives, including requirements development and user acceptance testing for analytical tools.
Manage multiple communication streams and follow escalation pathways where required.
Education & Experience Required
Bachelor’s degree (BS/BA) in Health Sciences, Life Sciences, Data Sciences, or related field.
Advanced degree (Master’s/PhD) preferred.
Minimum 4+ years of experience in Pharmaceutical, CRO, or Biotech industry.
Strong knowledge of clinical trial site operations and study execution.
Working knowledge of ICH-GCP and global regulatory guidelines.
Demonstrated understanding of data analytics and basic statistical concepts.
Experience in project, issue, and risk management.
Experience working with clinical data platforms, reporting tools, and analytics systems.
Strong written and verbal communication skills in English.
Preferred Experience
Experience with complex data structures and reporting specifications.
Exposure to external datasets such as Safety Labs, Pharmacokinetics (PK), Biomarkers, ECG, etc.
Knowledge of Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), and Quality by Design (QbD).
Proficiency in statistical analysis, data modelling, and data visualization techniques.
Core Competencies
Clinical Data Management
Advanced Analytics & Biostatistics
Good Clinical Practice (GCP)
Cross-Functional Collaboration
Systems Analysis
Data Privacy Standards
Problem Solving & Critical Thinking
SOP Compliance & Report Writing
Why Apply?
This opportunity is ideal for clinical data professionals seeking to advance in Analytical Risk-Based Monitoring within a globally recognized healthcare organization. The role offers exposure to advanced analytics, centralized monitoring technologies, and cross-functional collaboration in complex, multi-regional clinical trials.
For more global pharmaceutical, biotech, CRO, and clinical research job opportunities, explore verified listings on ThePharmaDaily.com.
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