Site Specialist II – Clinical Study Start-Up
Location: Bangalore, Chennai, Bengaluru (India)
Job ID: JR137225
Work Model: Office with Flex | Full Time
Experience Required: 3–6 Years
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a skilled Site Specialist II to support study start-up, site maintenance and contract management activities. This role is part of the high-performing Site Activation team and is ideal for professionals with strong knowledge of site-level clinical operations and regulatory processes.
The position focuses on timely, compliant, and efficient activation and maintenance of clinical trial sites across global studies.
Key Responsibilities
Study Start-Up
Support site activation activities, including review of essential documents and coordination of the green-light process.
Ensure all required documentation is complete, accurate, and compliant with regulatory standards.
Facilitate site activation readiness in alignment with study timelines.
Site Maintenance
Manage customization of site-specific Informed Consent Forms (ICFs).
Coordinate translation requirements and handle IRB/EC submissions.
Maintain documentation and updates in eTMF systems throughout the study lifecycle.
Contract Management
Assist in contract workflow processes, including budget understanding and review of contract amendments.
Participate in contract negotiations and ensure timely execution of final agreements.
Coordinate communication with internal teams and external sites to maintain clarity and compliance.
Collaboration & Communication
Work closely with cross-functional teams to achieve project milestones.
Maintain clear, professional communication with global stakeholders.
Adapt to flexible work hours to support international teams.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Business, or related field.
3–6 years of relevant experience in clinical study start-up, site maintenance, and contract management.
Solid understanding of ICF customization, regulatory submission workflows, IRB/EC interactions, and contract processes.
Strong organizational and multitasking skills with demonstrated attention to detail.
Excellent written and verbal communication skills.
Ability to work flexible shifts based on global study needs.
What ICON Offers
ICON provides a competitive salary package and a range of comprehensive benefits tailored to support employee well-being and long-term growth. Benefits may include:
Generous annual leave entitlements
Health insurance options for employees and families
Retirement planning and savings programs
Global Employee Assistance Programme (LifeWorks)
Life assurance coverage
Country-specific optional benefits such as childcare vouchers, cycle-to-work schemes, discounted gym memberships, travel subsidies, and more
Visit ICON’s careers page for full benefits information.
Commitment to Inclusion
ICON is committed to fostering an inclusive, accessible and discrimination-free workplace. All qualified applicants will receive equal consideration without regard to race, gender, nationality, disability, or protected veteran status.
Candidates requiring reasonable accommodations during the application or hiring process may submit a request through ICON’s accessibility support channels.
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