Clinical Study Administrator

As a Clinical Study Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Job Title: Clinical Study Associate
Working Location: Hong Kong Client Office based

What you will be doing:

• Assist CRAs to prepare, distribute, maintain and archive investigator site files in accordance with the standard operating procedures and the ICH-GCP guidelines
• Support TMF management at study and site level and optimize TMF management process
• Manage all payments related to clinical trial activities.
• Draft and prepare investigator site budgets and agreements as well as EC and RA submission documents under the guidance of CRA and CSM
• Responsible for study drug management, including import license applications, custom clearance and fulfil regulatory requirements (i.e. PLAMMS); lead cross function team to response customs issues; responsible for customs policies interpretation to SDT, Supply Chain, LST
• Support procurement processes, including but not limited to, vendor bidding, assessments, due diligence, setup PO/PR for CROs and other vendors, purchasing clinical supply and equipment, in collaboration with CSM and the Procurement team

You are:

• Bachelor degree or above in life science or healthcare-related field, or equivalent.
• At least 1-year experience as CTA/CTC/CRC or equivalent experience.
• Knowledge in clinical study process and understanding of the ICH/GCP guideline.
• Good interpersonal skills and ability to work in an international team environment.
• Good computer skills in Microsoft and other software.
• Proficient written and verbal communication skills, collaboration and interpersonal skills.
• Proven organizational and administrative skills.
• Good written and verbal communication skills in English and Cantonese

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.

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