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As a (Senior) CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Job purpose
Prepare / submit clinical trial application dossier according to the given instruction from the responsible CSM / responsible CRAs while fully GCP, ICH, local regulations and Novartis SOP complaint and maintain in-house TMF submission documents properly.
Major Accountabilities
- Prepare the EC submission for new / ongoing clinical trials
- Translate the global English study documents/tools(e.g. Informed consent form/protocol synopsis/ patient diary, etc.) into Chinese and prepare the translation of validation form properly and timely according to Novartis local SOP.
- Follow up the EC review status of assigned projects
- Coordinate the response to EC queries and ensure the reply is timely submitted to EC
- Setup and maintain the submission dossiers
- Serve as CTA hub contact to upload local documents for HA submission to REDI_AA and submit the completed dossier to HA
- May serve as a backup for IMP CPO contact defined in local SOP in term of clinical trial supplies management according to the assignment
- Align with CRAs/CSMs to generate the start up plan milestone dates and ensure that study milestones are met as planned (i.e. submission & approval date, startup, recruitment, closeout, etc).
You are:
Bachelor Degree (or above) in science field, or relevant working experience in clinical research- Good English (oral and written)
- Ability to manage submission for EC/HA
- Familiar with GCP/ICH, EC/HA regulation and practice
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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