Site Specialist II role in Chennai. Lead site activation tasks: SSU, ICF customization, contract mgmt & EC submissions. 3+ yrs exp in clinical trial start-up required. Office-flex role.
Accelerate Clinical Trials: Be the Engine of Site Activation in Chennai
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.
We are seeking a skilled and process-driven Site Specialist II to join our high-performing Site Activation team in Chennai. This is a pivotal office-flex role where you will be the operational expert driving critical start-up, maintenance, and contract activities for clinical trial sites worldwide. Your expertise will ensure sites are activated faster, contracts are finalized efficiently, and all activities comply with global standards. If you thrive on managing details, navigating regulatory pathways, and collaborating across global teams, this is your opportunity to shape the future of clinical development from one of ICON’s key hubs.
Your Mission: Own the Operational Pathway to Site Activation
As a Site Specialist II, you will manage a portfolio of site-level activities from initial green light through to ongoing maintenance. You will be the go-to expert for document readiness, ethical submissions, and contract workflows, directly impacting our ability to initiate studies on time.
Key Responsibilities
1. Lead Study Start-Up (SSU) & Site Activation
- Support the green light process and manage site activation readiness by collecting, reviewing, and ensuring the completeness of essential documents.
- Customize site-specific Informed Consent Forms (ICFs), coordinate professional translations, and manage submissions to Ethics Committees (EC) / Institutional Review Boards (IRB).
- Ensure all documentation is accurately filed in the electronic Trial Master File (eTMF) in a timely and inspection-ready manner.
2. Contract Management & Negotiation Support
- Assist in the end-to-end site contract and budget workflow, from initial drafting through to negotiation and execution.
- Manage contract amendments and participate in negotiations with sites to reach timely agreement.
- Ensure finalization and proper archival of all fully executed agreements.
3. Cross-Functional Collaboration & Global Support
- Collaborate effectively with Clinical, Legal, Feasibility, and Regulatory teams to resolve site-level issues and meet activation timelines.
- Communicate clearly and confidently with internal teams and external sites/investigators across different regions.
- Work flexible hours/shifts as needed to align with global operational demands and support international colleagues.
Who You Are: The Ideal Candidate
You are a meticulous, proactive professional with a solid grounding in clinical trial operations. You excel in a fast-paced, detail-oriented environment and are passionate about building efficient processes to accelerate clinical research.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Business Administration, or a related field.
- Minimum of 3 years of direct, hands-on experience in clinical trial study start-up, site maintenance, and/or contract management within a CRO, pharmaceutical, or biotech company.
- Strong understanding of essential document requirements, ICF customization, EC/IRB submission processes, and contract workflows.
- Exceptional organizational skills with the ability to manage multiple priorities and maintain unwavering attention to detail.
- Excellent written and verbal communication skills in English, with the ability to liaise professionally across global teams.
- Willingness to work flexible shifts to support global time zones.
Highly Desirable:
- Direct experience using eTMF systems (e.g., Veeva Vault) and contract management platforms.
- Experience in budget negotiation and a clear understanding of clinical trial agreements (CTAs).
- Familiarity with ICH-GCP guidelines and local regulatory requirements.
Why Build Your Career as a Site Specialist at ICON in Chennai?
1. Central Role in Clinical Operations
- Be at the heart of the study activation process, a critical path function with high visibility and impact on trial timelines.
- Develop a specialized, highly valuable skill set in global site activation and contracts.
2. Career Growth in a Global Hub
- Clear progression pathway to Senior Site Specialist, Team Lead, or Study Start-Up Manager roles within our expanding Chennai operations hub.
- Gain exposure to a wide variety of therapeutic areas and complex global studies.
3. Office-Flex Model & Comprehensive Benefits
- Enjoy the collaboration of our Chennai office with a flexible hybrid working model.
- Competitive salary and performance-based bonus.
- Generous annual leave entitlements.
- Comprehensive health insurance and wellness programs.
- Global Employee Assistance Programme for 24/7 support.
Join a Culture that Values Operational Excellence
At ICON, we believe that diverse teams drive better outcomes. We are committed to creating an inclusive, accessible environment and encourage all qualified candidates to apply.
Ready to be the key that unlocks site activation for global clinical trials?
If you are an operational expert passionate about efficiency and quality, apply now to join our Chennai team.
