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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
We are currently seeking a Study Review Specialist to join our dynamic team. As a Study Review Specialist, you will collaborate with cross-functional teams to ensure documentation accuracy, compliance, and consistency across studies. This position offers an excellent opportunity to build expertise in clinical document management and contribute to operational excellence within a global organization.
Review and approve Critical Document Packages (CDPs) prior to IP release, ensuring compliance with ICON and Sponsor SOPs, ICH/GCP principles, and applicable country regulations.
Apply a thorough understanding of ICON SOPs/WPs, ICH/GCP, and regulatory guidelines in day-to-day activities.
Maintain accurate documentation and timely data entry of all review and approval activities in relevant ICON tracking systems.
Ensure CDP approval timelines are achieved and accurately reflected within ICON systems, escalating potential delays proactively.
Conduct internal quality reviews of document packs (parallel reviews) or Trial Master File (TMF) records where assigned.
Collaborate with internal stakeholders to optimize performance and ensure successful project outcomes.
Act as a Subject Matter Expert (SME) for assigned processes, maintaining current knowledge of evolving regulatory and procedural requirements.
Participate in study team meetings and support cross-functional communication.
Mentor and coach new hires during onboarding, sharing best practices and procedural insights.
Support key process improvement initiatives, technology adoption, and efficiency enhancements to meet KPIs and deliver high-quality outcomes.
Perform other duties as assigned in accordance with corporate and departmental SOPs.
Bachelor's degree in Life Sciences or a related field.
1-3 years of experience in clinical research with exposure to study start-up, regulatory, or document review functions.
Strong understanding of clinical trial processes and document management workflows.
High attention to detail with the ability to ensure documentation accuracy and compliance.
Effective communication and stakeholder collaboration skills.
Proficiency with documentation and tracking systems.
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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our 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.
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 to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.We offer a full range of consulting, development and commercialisation services from a global network of offices in 37 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Job ID: 145546883
