Site Specialist II

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.

Role Summary

As a Site Specialist II at ICON, you will independently manage site start-up, regulatory, ethics, contract, and site support activities, acting as a key operational contact for sites and contributing to efficient study activation and maintenance in accordance with ICH/GCP, applicable regulations, and ICON procedures.

What You Will Do

• Coordinate site-level document collection, review, maintenance, and tracking, ensuring accuracy and compliance for assigned sites and studies.
• Support and manage regulatory start-up and maintenance submissions to Central EC/IRB, Local EC/IRB, Competent Authorities, and other local regulatory authorities as required.
• Collect, review, organize, and assemble Critical Document Packages (CDP), ensuring Sponsor and Investigator obligations are met and maintained in compliance with ICH/GCP and local regulations.
• Act as an operational liaison for site staff regarding documentation, systems, regulatory processes, and site activation requirements.
• Support contract negotiation activities, regulatory/ethics submissions, and CDP collection where applicable within the Malaysian operating model.
• Maintain accurate site status, metrics, forecasts, milestones, and progress data within clinical trial management systems and tracking tools.
• Coordinate translations required for start-up documentation and ensure timely completion of activation deliverables.
• Participate in study review meetings, identify study and site risks, support mitigation planning, and contribute to successful site activation outcomes.
• Ensure Trial Master File (TMF) documents are complete, accurate, quality checked, and transferred appropriately for filing.
• Support planning and logistics for investigator meetings, monitoring visits, and other study activities.
• Identify opportunities to streamline workflows, improve quality, and enhance operational efficiency.
• Provide guidance and support to Site Specialist I colleagues and share best practices.
  
  

Your Profile

• Bachelor's degree in Life Sciences, Healthcare, Business, or a related field, or equivalent clinical research experience.
• 3 to 6 years of experience in clinical research, site start-up, regulatory affairs, site support, or related CRO, pharmaceutical, or healthcare environments.
• Good understanding of clinical trial processes, ICH/GCP, ethics and regulatory submissions, site activation activities, and clinical documentation requirements.
• Strong organizational skills with the ability to prioritize competing activities and manage multiple sites simultaneously.
• Proficiency with Microsoft Office applications and clinical trial systems.
• Ability to work independently, identify risks, document issues appropriately, and collaborate effectively with cross-functional stakeholders.
• Excellent communication, problem-solving, and stakeholder management skills.
  
  

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