Site Specialist II
ICON plc · Kuala Lumpur
Site Specialist IIICON 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.
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