Job Description

Study Review Specialist - Candidates must have hands-on experience in reviewing study start-up documents as a primary requirement, along with secondary experience in Contract QC - Office-based in Chennai / Bangalore

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Study Review Specialist to join our dynamic team. As a Study Review Specialist, you will collaborate with cross-functional teams to ensure documentation accuracy, compliance, and consistency across studies. This position offers an excellent opportunity to build expertise in clinical document management and contribute to operational excellence within a global organization.

What You Will Be Doing:

• Review and approve Critical Document Packages (CDPs) prior to IP release, ensuring compliance with ICON and Sponsor SOPs, ICH/GCP principles, and applicable country regulations.

• Apply a thorough understanding of ICON SOPs/WPs, ICH/GCP, and regulatory guidelines in day-to-day activities.

• Maintain accurate documentation and timely data entry of all review and approval activities in relevant ICON tracking systems.

• Ensure CDP approval timelines are achieved and accurately reflected within ICON systems, escalating potential delays proactively.

• Conduct internal quality reviews of document packs (parallel reviews) or Trial Master File (TMF) records where assigned.

• Collaborate with internal stakeholders to optimize performance and ensure successful project outcomes.

• Act as a Subject Matter Expert (SME) for assigned processes, maintaining current knowledge of evolving regulatory and procedural requirements.

• Participate in study team meetings and support cross-functional communication.

• Mentor and coach new hires during onboarding, sharing best practices and procedural insights.

• Support key process improvement initiatives, technology adoption, and efficiency enhancements to meet KPIs and deliver high-quality outcomes.

• Perform other duties as assigned in accordance with corporate and departmental SOPs.

Your Profile:

• Bachelor’s degree in Life Sciences or a related field.

• 1–3 years of experience in clinical research with exposure to study start-up, regulatory, or document review functions.

• Strong understanding of clinical trial processes and document management workflows.

• High attention to detail with the ability to ensure documentation accuracy and compliance.

• Effective communication and stakeholder collaboration skills.

• Proficiency with documentation and tracking systems.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here

Are you a current ICON Employee? Please click here to apply