Cta

7 months ago

Kuala Lumpur, Malaysia ICON plc Full time

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

You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration, and performance.

**What you will be doing**:

- Set up and maintain applicable TMF (both electronic and hard copy versions). Alert management where status of data quality or performance is at risk to noncompliance. from local area about site/investigator selection in collaboration with the trial team
- Prepare site specific ICF and any other relevant forms according to Novartis local SOP.
- Prepare and compile dossier for initial HA and IRB submission or amendment and oversee associated activities, responses, and communications with obtaining approvals for the assigned country(ies).
- Achieves successful delivery of site start-up, in-house site management and closeout activities meeting internal and external client requirements.
- Ensure the successful negotiation and ongoing management of clinical trial agreements with investigative sites and vendor agreements and associated budget management.

**You are**:

- Minimum of 2 years’ experience in Global Clinical
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and
- regulations, assigned protocols and associated protocol specific procedures including monitoring.
- Strong IT skills in appropriate software and company systems. Willingness to travel with
- occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English.
- Good written and oral communication skills.

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

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.

At 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.

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.

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