Central Monitor Assistant
Location: Bangalore
Employment Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: 262504
Job Summary
The Central Monitor Assistant supports centralized clinical trial monitoring and study operations by managing clinical trial systems, maintaining study databases, coordinating investigator payments, supporting data review activities, and ensuring accurate study documentation. The role works closely with Clinical Research Associates (CRAs), Clinical Trial Leads (CTLs), Project Managers (PMs), and study teams to ensure efficient study execution and compliance with ICH-GCP guidelines.
This position is ideal for professionals with experience in clinical operations, study coordination, clinical systems management, and trial administration.
Key Responsibilities
Clinical Systems Management
Manage user access and permissions across clinical trial systems.
Perform study setup activities for newly awarded studies.
Maintain and support:
Clinical Trial Management System (CTMS)
Interactive Web Response System (IWRS)
Electronic Data Capture (EDC)
Electronic Trial Master File (eTMF)
Monitor CTMS compliance and data quality.
Troubleshoot and escalate system-related issues when required.
Data Review & Central Monitoring Support
Support centralized monitoring and study management activities.
Follow up with CRAs regarding:
Outstanding action items
Query resolution
Data discrepancies
Assist Lead Monitors with study-specific data review tasks.
Support study teams in identifying and resolving operational issues.
Generate study-specific reports and performance metrics.
Study Support Activities
Generate and distribute study reports.
Support project communications and coordination activities.
Assist project teams with operational and administrative study tasks.
Track study deliverables and ensure timely completion of assigned activities.
Support implementation of revised study processes and procedures.
eTMF & Document Management
Assist with:
Document collection
Review and processing
Tracking and filing activities
eTMF maintenance
Ensure study documents remain complete, accurate, and inspection-ready.
Create and maintain document templates as required.
Follow up with study teams regarding missing or incomplete documentation.
Support document uploads and query resolution.
Site Start-Up Support
Assist study start-up teams with:
Site activation activities
Investigator documentation collection
Regulatory submission packages
Prepare and maintain investigator submission packages.
Create and manage Investigator Site Packs (iSite Packs).
Support site contract review and management according to established timelines.
Investigator Payment Processing
Review:
EDC data
Site contracts
Study milestones
Mark payment items as:
Ready to Pay
Screen Failure
Generate:
Cover Letters
Proforma Invoices
Payment Batches within CTMS
Perform:
Invoice Quality Control (QC)
Grant-In-Aid (GIA) Preparation
Payment Reconciliation
Process:
Out-of-Pocket Expenses
Pass-Through Expense Invoices
Coordinate approvals with:
Clinical Trial Leads (CTLs)
Project Managers (PMs)
Finance Teams
Compliance & Quality Assurance
Follow departmental:
Standard Operating Procedures (SOPs)
Work Instructions
Quality Standards
Complete required training programs within established timelines.
Perform quality checks on assigned work.
Ensure timely escalation and resolution of issues.
Track and report study metrics as required.
Maintain accurate project and technical documentation.
Administrative & Operational Support
Provide administrative and technical support to internal departments.
Manage assigned studies according to project objectives.
Support upload management and study documentation activities.
Assist with study closeout activities when required.
Perform additional duties assigned by management.
Required Qualifications
Educational Requirements
Bachelor's Degree in:
Life Sciences (Preferred)
Pharmacy
Biotechnology
Medical Sciences
Nursing
Allied Health Sciences
OR
Certification in an accredited allied health profession such as:
Nursing
Medical Technology
Laboratory Technology
Equivalent relevant experience may be considered in lieu of educational qualifications.
Required Experience
Experience Level
2–3 years of experience in:
Clinical Research
Clinical Operations
Clinical Trial Administration
Study Coordination
Site Management
Central Monitoring Support
Industry Knowledge
Strong understanding of:
ICH-GCP Guidelines
Clinical Trial Processes
Clinical Study Documentation
Site Start-Up Activities
Investigator Payments
Regulatory Compliance Requirements
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Japan | Saitama |Tokyo :
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