Senior Site Specialist

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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