ICON Hiring Clinical Study Review Specialist
- ICON Hiring Study Review Specialist | Clinical Research Role for 1–3 Years Experience in Bangalore & Chennai
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Relevant Courses:
- Experience:
- Required Skills
- Location & Salary
- Application Process
- Why This Role Matters
- Frequently Asked Questions (FAQs)
- Who can apply for this role?
- Is study start-up experience required?
- What is TMF in clinical research?
- What is the work model?
- What career growth can I expect?
ICON Hiring Study Review Specialist | Clinical Research Role for 1–3 Years Experience in Bangalore & Chennai
ICON plc is hiring for the role of Study Review Specialist in the Study Start-Up and Clinical Operations department across Bangalore and Chennai locations. This opportunity is ideal for candidates with 1 to 3 years of experience in clinical research, especially those with exposure to study start-up documents, regulatory review, and Trial Master File (TMF) management.
This is a high-growth role for professionals aiming to build expertise in clinical trial documentation, regulatory compliance, and global CRO operations. If you are looking to advance your career in clinical research and work with a globally recognized organization, this role offers strong learning exposure and career progression.
Company Overview
ICON plc is a leading global clinical research organization (CRO) providing healthcare intelligence, clinical development, and regulatory support services to pharmaceutical, biotechnology, and medical device companies. With a strong global presence and a reputation for operational excellence, ICON plays a key role in accelerating clinical trials and bringing innovative therapies to market.
The company is known for its quality-driven processes, advanced clinical technologies, and collaborative work culture. Employees at ICON gain exposure to global clinical trials, regulatory frameworks, and high-impact healthcare projects.
Job Role & Responsibilities
As a Study Review Specialist, you will be responsible for reviewing and validating clinical trial documentation, ensuring compliance with global regulatory standards and internal SOPs.
Key Responsibilities:
Study Document Review & Compliance
- Review Critical Document Packages (CDPs) before Investigational Product (IP) release
- Ensure compliance with ICH-GCP guidelines, ICON SOPs, and sponsor requirements
- Perform quality checks on clinical documents and regulatory submissions
Clinical Trial Documentation & TMF Management
- Maintain accurate documentation in clinical trial systems and tracking tools
- Conduct internal quality reviews of Trial Master File (TMF) records
- Ensure timely approval and documentation of study-related activities
Cross-Functional Collaboration
- Work closely with clinical operations, regulatory teams, and study stakeholders
- Participate in study meetings and support project communication
- Escalate delays or issues related to document review timelines
Process Improvement & Mentorship
- Act as a Subject Matter Expert (SME) for assigned processes
- Support onboarding and training of new team members
- Contribute to process improvement initiatives and efficiency enhancements
Eligibility / Qualifications
Educational Qualification:
Bachelor’s degree in Life Sciences or related field
Relevant Courses:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research
Experience:
- 1 to 3 years of experience in clinical research, study start-up, or regulatory documentation
- Experience in document review or TMF management is preferred
Required Skills
- Strong understanding of clinical trial processes and ICH-GCP guidelines
- High attention to detail and documentation accuracy
- Good communication and stakeholder collaboration skills
- Familiarity with clinical document management systems
- Ability to manage timelines and multiple tasks effectively
Location & Salary
- Job Location: Bangalore & Chennai, India
- Work Model: Hybrid
- Salary: Competitive salary package based on experience in clinical research and CRO industry
Application Process
Interested candidates can apply directly through the official ICON careers portal:
Apply Here: https://careers.iconplc.com/job/study-review-specialist-in-india-chennai-jid-49714
Why This Role Matters
Study start-up and document review are critical steps in clinical trial execution. Ensuring accurate and compliant documentation helps maintain data integrity, regulatory approval, and patient safety. This role provides hands-on experience in global clinical trials, regulatory compliance, and CRO operations, making it a strong foundation for long-term growth in clinical research.
Frequently Asked Questions (FAQs)
Who can apply for this role?
Candidates with Life Sciences degrees and 1–3 years of clinical research experience can apply.
Is study start-up experience required?
Yes, experience in reviewing study start-up documents is a key requirement.
What is TMF in clinical research?
TMF (Trial Master File) is a collection of essential documents that demonstrate compliance with clinical trial regulations.
What is the work model?
The role follows a hybrid work model in Bangalore or Chennai.
What career growth can I expect?
You can progress to roles such as Clinical Trial Associate, Study Start-Up Specialist, or Clinical Project Manager.
| Category | Details |
|---|---|
| Company | ICON plc |
| Vacancies | Study Review Specialist |
| Required Education | Life Sciences |
| Experience | 1–3 Years |
To apply for this job please visit careers.iconplc.com.
