Office or Home Job ICON plc Hiring for Site Specialist II
Site Specialist II – ICON plc
Location: Bangalore / Chennai, India
Work Type: Office or Home (Flexible)
Employment Type: Full-Time
Job Requisition ID: JR133278
Posted On: Today
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization that helps pharmaceutical, biotechnology, and medical device companies bring life-saving products to market faster. The company is known for its innovation, scientific excellence, and commitment to improving patient outcomes through efficient clinical development. Office or Home Job ICON plc Hiring for Site Specialist II
ICON’s mission is to shape the future of clinical research by combining advanced technologies, data-driven insights, and global expertise. The company fosters an inclusive work culture that values teamwork, learning, and continuous improvement. Office or Home Job ICON plc Hiring for Site Specialist II
Job Overview
ICON plc is seeking a Site Specialist II to join its Clinical Operations team in India. This role offers the opportunity to contribute to site activation activities, vendor coordination, and documentation management for clinical studies. Office or Home Job ICON plc Hiring for Site Specialist II
As a Site Specialist II, you will play a vital role in ensuring that clinical sites are activated efficiently and in compliance with regulatory standards. You will work closely with internal and external stakeholders to facilitate smooth study start-up and ongoing operational excellence. Office or Home Job ICON plc Hiring for Site Specialist II
This position is ideal for professionals with foundational experience in clinical research or site operations who are looking to advance their career in a global organization.
Key Responsibilities
- Vendor Management: Coordinate with external vendors (eCRF, IVRS) and internal teams to manage vendor access and site activation activities.
- Documentation Handling: Prepare, review, and maintain Clinical Document Packages (CDP) and submission documentation, ensuring accuracy, consistency, and compliance.
- Tracking and Reporting: Maintain and update study trackers to capture all activities, deliverables, and milestones accurately within ICON’s systems.
- Cross-Functional Collaboration: Work closely with Site Partners, Clinical Research Associates (CRAs), In-House CRAs (IHCRAs), and Clinical Trial Assistants (CTAs) to ensure timely site activation and smooth study execution.
- Planning and Forecasting: Support the forecasting and tracking of site activation plans, ensuring deliverables are aligned with project timelines and client expectations.
- Meetings and Reviews: Participate in internal study review meetings to support risk identification, mitigation, and action planning for activation-related issues.
- TMF Quality Assurance: Ensure completeness and quality of the Trial Master File (TMF) through timely document submissions and quality control reviews.
- Compliance: Apply knowledge of ICH-GCP, ICON SOPs/WPs, and applicable country-specific regulatory guidelines to ensure that all activities meet global compliance standards.
- Other Duties: Perform additional responsibilities as assigned to support broader departmental or project objectives.
- Office or Home Job ICON plc Hiring for Site Specialist II
Candidate Profile
Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
Experience:
- Minimum of 3 years of experience in clinical research, site operations, or clinical documentation management.
- Experience working with vendor systems such as eCRF, IVRS, or similar tools is desirable.
Knowledge and Skills:
- Strong understanding of clinical trial processes and documentation workflows.
- Familiarity with global clinical research regulations and start-up activities.
- Excellent organizational and documentation skills with attention to detail.
- Strong interpersonal and communication skills for cross-functional collaboration.
- Ability to manage multiple priorities in a fast-paced, matrixed environment.
- Working knowledge of ICH-GCP guidelines, regulatory standards, and ICON SOPs/WPs.
- Office or Home Job ICON plc Hiring for Site Specialist II
What ICON Can Offer You
ICON recognizes that its success depends on the quality, dedication, and expertise of its people. The company offers a comprehensive benefits package designed to support employees and their families while promoting work-life balance and long-term career development. Office or Home Job ICON plc Hiring for Site Specialist II
Key Benefits Include:
- Competitive annual salary and performance-based rewards.
- Various annual leave entitlements.
- Health insurance plans designed to meet diverse family needs.
- Competitive retirement planning options to secure your future.
- Access to the Global Employee Assistance Programme (TELUS Health), providing 24-hour access to professional support for well-being and mental health.
- Life assurance and additional country-specific benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments.
Inclusion and Accessibility
At ICON, inclusion and belonging are fundamental values. The organization is committed to creating a work environment that is diverse, equitable, and free from discrimination and harassment. Office or Home Job ICON plc Hiring for Site Specialist II
All qualified applicants will receive consideration for employment regardless of race, religion, gender, sexual orientation, gender identity, disability, veteran status, or national origin.
If you require a reasonable accommodation during the recruitment process or while performing essential job functions due to a medical condition or disability, ICON encourages you to reach out for assistance. Office or Home Job ICON plc Hiring for Site Specialist II
Why Join ICON
- Work with a global leader in clinical research and healthcare intelligence.
- Collaborate with experienced professionals on meaningful, patient-focused studies.
- Develop your career through structured training and mentorship.
- Be part of a culture that rewards innovation, accountability, and teamwork.
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