Site Specialist II – Clinical Trial Site Activation
Company: ICON plc
Job Title: Site Specialist II
Job Requisition ID: JR155811
Job Type: Full-time
Locations: Bengaluru / Chennai, India
Work Model: Office With Flex (Hybrid Flexibility)
Experience Required
Minimum Experience: 3+ years
Relevant experience in:
Clinical Trial Site Start-Up
Site Activation
Clinical Operations
Regulatory Submissions
Contract Management
Educational Qualification
Candidates should possess:
Bachelor’s Degree in:
Life Sciences
Clinical Research
Pharmacy
Biotechnology
Healthcare
Business or related fields
Department
Clinical Operations – Site Activation & Study Start-Up
Job Summary
ICON is hiring a Site Specialist II to support clinical trial site activation, maintenance, and contract management activities. The role focuses on ensuring clinical trial sites are prepared, compliant, and activated within required timelines.
The selected candidate will work with Principal Investigators (PIs), clinical sites, regulatory teams, sponsors, and internal stakeholders to manage essential documents, ethics committee submissions, informed consent documentation, contracts, and site readiness activities.
Key Responsibilities
Study Start-Up Activities
Support clinical trial site initiation and activation processes.
Review and manage essential regulatory documents.
Coordinate site activation readiness and green-light processes.
Ensure all required documentation is complete before study initiation.
Manage India site start-up activities including:
Local Ethics Committee (LEC) submissions
Informed Consent Form (ICF) customization
Clinical Document Package (CDP) activities
Site activation readiness
Site Maintenance Activities
Manage ongoing site documentation requirements.
Coordinate site-specific ICF updates and translations.
Support IRB/EC submission processes.
Maintain accurate records in electronic Trial Master File (eTMF) systems.
Ensure compliance with clinical trial regulations and sponsor requirements.
Contract Management Activities
Understand clinical site contract workflows.
Support contract amendments and updates.
Participate in contract discussions and negotiations.
Track contract execution and completion.
Ensure agreements are finalized within timelines.
Stakeholder Management
Act as the site-facing contact for clinical trial activation.
Coordinate with:
Principal Investigators (PIs)
Site coordinators
Regulatory teams
Sponsors
Internal clinical operations teams
Maintain effective communication across global teams.
Resolve activation-related issues.
Required Skills
Clinical Trial Site Activation
Study Start-Up (SSU)
Clinical Operations
Regulatory Documentation
Ethics Committee (EC/IRB) Submissions
Informed Consent Form (ICF) Management
eTMF Documentation
Site Management
Contract Management
Clinical Trial Regulations
Stakeholder Communication
Project Coordination
Time Management
Attention to Detail
Preferred Skills
Hands-on experience with India clinical trial site activation.
Experience managing multiple clinical studies.
Knowledge of:
Local Ethics Committee submissions
Regulatory timelines
Site contracts
Translation workflows
Clinical trial documentation
Experience working with global clinical research teams.
Roles and Responsibilities
Manage multiple site activation activities simultaneously.
Ensure compliance with clinical research requirements.
Track timelines and deliverables.
Identify risks and coordinate corrective actions.
Maintain high-quality documentation standards.
Support global clinical operations teams.
Work flexible hours according to global project requirements.
Work Environment
Full-time employment.
Office with flexible work arrangement.
Collaboration with global clinical research teams.
Flexible working hours may be required to support international operations.
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization that supports pharmaceutical, biotechnology, and healthcare companies in developing new medicines and treatments. ICON provides clinical trial management, consulting, technology, and research services to accelerate healthcare innovation worldwide.
Estimated Salary Package
The official job posting does not disclose salary details. Based on market trends for Site Specialist / Clinical Trial Start-Up roles in India:
|
Experience |
Estimated Annual CTC |
|---|---|
|
3–4 years |
₹6 – ₹10 LPA |
|
4–6 years |
₹9 – ₹14 LPA |
Expected Average CTC: ₹8–12 LPA, depending on clinical trial experience, site activation expertise, location, and ICON’s compensation structure.
Who Should Apply
Candidates with:
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or related fields.
3+ years of clinical research experience.
Strong knowledge of site activation processes.
Experience with India-based clinical trial submissions.
Knowledge of EC/IRB submissions and ICF workflows.
Strong communication and organizational skills.
Ability to manage multiple priorities.
Locations
Bengaluru, Karnataka, India
Chennai, Tamil Nadu, India
Employment Type
Full-time
Office With Flex (Hybrid)
Key Highlights
Opportunity to work with a leading global Clinical Research Organization (CRO).
Direct involvement in global clinical trial start-up activities.
Exposure to regulatory submissions, site management, and contract processes.
Collaboration with international clinical operations teams.
Career growth opportunities in Clinical Operations and Study Start-Up.
Competitive benefits, training programs, and professional development opportunities.
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Remote, India | Siliguri |Illinois :
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Canada |Quebec :
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