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.
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
Qualification
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)
职能类别: 生物工程/生物制药
联系方式
上班地址:静安嘉里中心
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