Site Specialist II
Company: ICON plc
Location: Bangalore / Chennai, India (Office with Flex)
Employment Type: Full-Time
Experience Required: 3+ Years
Salary Package
Expected CTC: ₹8 LPA – ₹14 LPA (Estimated market range based on experience, site activation expertise, and organization. Actual salary may vary.)
Job Summary
ICON is seeking a Site Specialist II to support global clinical trial site activation, maintenance, and contract management activities. The role focuses on ensuring timely site start-up, regulatory compliance, documentation management, and collaboration with investigators, ethics committees, and cross-functional teams to enable successful clinical trial execution.
Key Responsibilities
Support clinical study start-up activities, including review of essential documents and site activation readiness.
Manage the Green Light Process and ensure sites meet activation requirements.
Customize site-specific Informed Consent Forms (ICFs) and coordinate document translation activities.
Prepare and manage Local Ethics Committee (LEC), Ethics Committee (EC), and Institutional Review Board (IRB) submissions.
Maintain accurate documentation within electronic Trial Master File (eTMF) systems.
Support site contract management, including contract amendments, negotiation coordination, and execution tracking.
Coordinate with Principal Investigators (PIs), site staff, sponsors, and internal teams throughout the site activation process.
Manage India-specific site activation activities, including LEC submissions, ICF customization, Clinical Document Package (CDP) preparation, and site readiness.
Ensure study timelines are achieved while maintaining compliance with regulatory and company requirements.
Collaborate with Clinical Operations, Regulatory Affairs, Legal, Contracts, and other cross-functional teams.
Maintain high-quality documentation and support audit and inspection readiness.
Work flexible hours to support global clinical trial operations.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Business, or a related discipline.
3+ years of experience in Clinical Research with expertise in Study Start-Up, Site Activation, or Clinical Trial Operations.
Hands-on experience managing India site activation across multiple clinical studies.
Experience with Local Ethics Committee (LEC), Ethics Committee (EC), and IRB submission processes.
Required Skills
Strong knowledge of study start-up and site activation processes.
Experience with Informed Consent Form (ICF) customization and translation workflows.
Knowledge of eTMF systems and clinical trial documentation.
Understanding of EC/IRB/LEC submission requirements.
Experience with site contract management and contract amendments.
Strong organizational and project management skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities while meeting project timelines.
Strong stakeholder management and cross-functional collaboration skills.
Attention to detail with a focus on regulatory compliance.
Preferred Skills
Experience working with global clinical trials and multinational sponsors.
Familiarity with ICH-GCP, Indian clinical trial regulations, and global regulatory requirements.
Experience supporting contract negotiations and execution.
Knowledge of Clinical Document Package (CDP) preparation.
Experience using CTMS, eTMF platforms, and other clinical trial management systems.
Ability to work effectively with global teams across different time zones.
Employee Benefits
Competitive base salary with performance-based incentives.
Medical, dental, and vision insurance (where applicable).
Retirement and pension plans.
Life insurance and disability coverage.
Employee Assistance Program (EAP).
Health and wellbeing initiatives.
Structured learning and career development programs.
Flexible office-based work model.
Opportunities to work on global clinical trials within a leading Clinical Research Organization (CRO).
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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