MAJOR RESPONSIBILITIES, AND DUTIES
* Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study.
* Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time.
* Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.
* Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trail end.
* Ensuring EDC/CTMS system is updated in a timely and accurate manner in accordance with requirements.
* Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP.
* Update investigator file and trial master file.
* Build and maintain positive relationships with the site and investigators.
* Ensure site visit reports and correspondence is completed in time.
QUALIFICATIONS
* Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse, BPharm)
* At least 3-10 years clinical operation monitor experience for senior position.
* Fluent English
* Good communication and organization skillsPositive and proactive working attitude
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