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Looking to advance your career in clinical research document review and study start-up operations? ICON plc is actively hiring a Study Review Specialist in Chennai and Bangalore. This opportunity is ideal for candidates with hands-on experience in reviewing study start-up documents and exposure to contract QC and TMF processes.
With increasing demand for clinical document management professionals, this role offers strong career growth in ICH-GCP compliance, regulatory documentation, and trial master file (TMF) review.
๐ Key Responsibilities โ Study Review Specialist
As a Study Review Specialist at ICON, you will:
- Review and approve Critical Document Packages (CDPs) before IP release
- Ensure compliance with ICH-GCP guidelines, sponsor SOPs, and regulatory standards
- Maintain accurate records in clinical tracking systems
- Monitor and meet CDP approval timelines, escalating delays proactively
- Conduct internal quality checks of document packs and TMF records
- Collaborate with cross-functional teams for efficient study execution
- Act as a Subject Matter Expert (SME) for assigned processes
- Participate in study meetings and support communication workflows
- Mentor junior team members and support onboarding
- Contribute to process improvement initiatives and KPI delivery
๐ Eligibility Criteria & Qualifications
To apply for this clinical research job in India, candidates must have:
- Bachelorโs degree in Life Sciences / Pharmacy / related field
- 1โ3 years of experience in clinical research
- Hands-on experience in study start-up document review (mandatory)
- Exposure to TMF, regulatory documentation, or contract QC
- Strong knowledge of clinical trial workflows and documentation systems
- Excellent attention to detail and compliance mindset
- Effective communication and stakeholder collaboration skills
๐ผ Salary & Benefits
- ๐ฐ Salary Range: โน4,00,000 โ โน7,00,000 per annum (estimated for 1โ3 years experience)
- ๐ฅ Health insurance coverage
- ๐ด Paid annual leave & work-life balance policies
- ๐ผ Retirement and savings plans
- ๐ Employee Assistance Programme (24/7 support)
- ๐ง Wellness programs and optional benefits (gym, travel, childcare, etc.)
๐ Job Location
- Chennai, Tamil Nadu
- Bangalore, Karnataka
- Work Mode: Office with Flexibility
๐ Why Choose This Study Review Specialist Role?
- High-demand domain: clinical trial documentation & compliance
- Exposure to global clinical research operations
- Opportunity to develop expertise in ICH-GCP, TMF, CDP review
- Career progression into Regulatory Affairs, Clinical Operations, or Quality Assurance
๐ฉ How to Apply
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