ICON, one of the world’s leading clinical research organizations (CROs), is hiring Study Review Specialists for its offices in Chennai and Bangalore. This opportunity is ideal for professionals with 1โ3 years of clinical research experience, particularly those with hands-on study start-up document review and contract quality control (QC) experience.
If you have experience reviewing Critical Document Packages (CDPs), Trial Master File (TMF) documentation, regulatory documents, and clinical study start-up activities, this role offers an excellent opportunity to grow your career with a globally recognized CRO.
Job Overview
| Details | Information |
|---|---|
| Company | ICON |
| Role | Study Review Specialist |
| Job Type | Full-Time |
| Work Mode | Office With Flex |
| Locations | Chennai, Bangalore |
| Experience | 1โ3 Years |
| Qualification | Bachelor’s Degree in Life Sciences or Related Field |
| Department | Clinical Research |
| Application Deadline | July 31, 2026 |
Key Responsibilities
As a Study Review Specialist, you will:
- Review and approve Critical Document Packages (CDPs) before Investigational Product (IP) release.
- Ensure compliance with ICON SOPs, Sponsor SOPs, ICH-GCP guidelines, and country-specific regulations.
- Maintain accurate review records in ICON tracking systems.
- Monitor documentation timelines and proactively escalate delays.
- Conduct internal quality reviews of Trial Master File (TMF) records.
- Collaborate with cross-functional clinical teams.
- Participate in study meetings and support operational excellence.
- Act as a Subject Matter Expert (SME) for assigned processes.
- Mentor new team members during onboarding.
- Support continuous process improvement initiatives and technology adoption.
- Perform additional documentation and compliance-related responsibilities.
Required Qualifications
Applicants should have:
- Bachelor’s degree in Life Sciences or a related discipline.
- 1โ3 years of clinical research experience.
- Mandatory hands-on experience reviewing Study Start-Up documents.
- Secondary experience in Contract Quality Control (QC).
- Strong understanding of:
- Clinical Trial documentation
- Study Start-Up processes
- Trial Master File (TMF)
- Critical Document Packages (CDPs)
- ICH-GCP Guidelines
- Regulatory compliance
- Excellent documentation, communication, and collaboration skills.
- Experience using documentation tracking systems.
Preferred Skills
- Study Start-Up Documentation Review
- Clinical Document Management
- Trial Master File (TMF)
- Regulatory Documentation
- Contract QC
- ICH-GCP Compliance
- SOP Compliance
- Clinical Operations
- Stakeholder Management
- Quality Review
Benefits
ICON offers an attractive employee benefits package including:
- Competitive salary with performance incentives
- Medical and health insurance
- Dental and vision benefits (where applicable)
- Retirement and pension plans
- Life insurance coverage
- Employee Assistance Programs
- Learning & Development opportunities
- Career growth within a global CRO
- Flexible office work model
Why Join ICON?
ICON is a globally recognized Clinical Research Organization dedicated to accelerating the development of innovative medicines. Employees work alongside global clinical teams while maintaining high standards of regulatory compliance, documentation quality, and operational excellence.
The Study Review Specialist role provides valuable exposure to:
- Clinical Trial Start-Up
- Regulatory Documentation
- Global Clinical Operations
- Trial Master File Management
- Quality Assurance
- Cross-functional Collaboration
How to Apply
