HGRAC Specialist I

As a HGRAC Specialist, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Support on HGR application submission, including but not limited to on-line submission, site filing, tracking and application form, format review based on study need in a timely manner.
• Implement HGR strategy at operation level to keep low rejection rate and good compliance in line with the regulation and internal process.
• Support to oversee HGR compliance during study execution, including but not limited in HGR submission application, HGR quality issue, study remaining sample retention.
• Responsible for HGR self-check, audit, inspections on study level and relative report format management.
• Responsible for authority contact and consultation, conduct the HGR regular refreshing training.
• Support the development and upgrade the internal used HGR system.
• Support to the development and update of HGR SharePoint as end to end tools with process excellence mindset.
• Key person for HGR submission accounts maintenance, and other tasks assigned by line manager.

You are:

• Bachelor or above in medical, pharmaceutical, and biological science and equivalent.
• At least 2 years’ experience in clinical operations or other related fields, including 1 years’ experience in HGR management.
• Have knowledge of drug development and local regulations.
• Good communication and collaborative skills.
• Fluent in both oral and written English.

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 maximise 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 careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.