Senior Site Specialist

Senior Site Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Senior Site Specialist, you will serve as a key operational point of contact for investigator sites, supporting site start-up, maintenance, and close-out activities. You will take ownership of complex site tasks and help drive a positive, efficient site experience. Also, because the position is partially related to Regulatory Submissions, you will be responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics, ensuring compliance with ICH-GCP, relevant regulations, and sound scientific principles. You will also contribute to process improvement initiatives, mentor junior staff as needed, and provide strategic input into submissions planning.

What You Will Do:

Your experience in site management and operations will be key in delivering high-quality outcomes and mentoring colleagues.

Key responsibilities include:

• Managing advanced site-level activities, including essential document collection, review, and maintenance for assigned sites or studies.

• Acting as a primary liaison for site staff on operational questions, documentation requirements, and study processes.

• Ensuring accurate and timely updates of site status and information in clinical trial management systems and trackers.

• Supporting coordination of site visits, meetings, and communications in collaboration with CRAs and project teams.

• Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.

• Providing guidance and mentorship to junior team members on best practices and procedures.

• Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards.

• Apply advanced knowledge of ICON SOPs/WIs, ICH-GCP, and local regulatory requirements.

• Contribute to strategic planning of submissions to Regulatory Authorities (RA), Central Ethics Committees (CEC), and other applicable bodies.

• Prepare, adapt, coordinate, and collate submission documentation per study and country requirements.

• Manage internal and external reviews of regulatory documentation and ensure accuracy of data in systems such as CTMS and eTMF.

• Oversee translation management and submission lifecycle through approval.

• Maintain proactive communication with project teams to ensure timely updates on submission and approval status.

• Collaborate cross-functionally to ensure regulatory deliverables are met.

• Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional levels.

You Are:

• Educated to degree level in life sciences or related discipline.

• Strong experience in site support, clinical administration, or similar roles within CRO, pharma, or healthcare.

• Good understanding of clinical trial processes, GCP, and site documentation requirements.

• Experienced with regulatory affairs in clinical research.

• Fluent in English.

• Highly organized with excellent attention to detail and ability to manage multiple priorities.

• A strong communicator with the ability to engage internal teams and external stakeholders effectively.

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply