Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia (Hybrid/remote)

Job Description

This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with a leading CRO or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

Responsibilities

(a) Site management

• Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
• Prepa...