Major Responsibilities

Assists Clinical Operations Manager to manage clinical studies or leads clinical studies independently, if required

• Assists Clinical Operations Manager (COM) or leads independently (COM II) to plan, organize, and manage all aspects of assigned clinical trial(s)
• Assists COM or leads independently to manage the efforts of all key functional departments to perform all project-related activities according to project milestones/timelines or leads (ACOM II) these activities, if required.
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Performs Quality Oversight Visit (QOV)

• Prepares QOV by being familiar with study protocol, plans, previous monitoring reports, follow-up letters, etc.
• Conducts on-site QOV
• Completes QOV reports
• Follows-up with CROs and relevant parties for actions/ resolutions for issues identified through the QoVs
• Prepares “lessons learnt” document and shares with the clinical operations team after the QoVs

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
• 4 years or more years of clinical research experience in the Pharmaceutical, CRO or relevant filed
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking)

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