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职位关键词(点击搜索): 临床项目经理; 临床; 经理; 项目; 

临床项目经理 (651861)

招聘单位:苏州康乃德生物医药有限公司 [2022-04-06]  阅读:

职位信息
职位名称: 临床项目经理 职位类别: 其它
工作性质: 全职 应聘/招聘人数: 0/1
工作地区: 太仓城厢 作息制度:
住房食宿: 月薪水平: 面议或未公开
工作描述: 职位编号Job Code: CNCD01
职位 Position: Clinical Project Manager
部门 Department: Clinical Development
汇报关系 Reports to: Associate Director of Clinical Operation
办公地点 Location: Flexible

职位目标 Purpose or Objective of Position:
The Clinical Project Manager is responsible for managing the clinical study in accordance with ICH-GCP, applicable legal/regulatory requirements and Connect’s policies and SOPs, and ensure clinical trials conducted within defined budget and timeline.

主要职责 Key Responsibilities:
 Plans and executes study operation activities to ensure the effective delivery of clinical studies by collaborating with cross-functional teams, vendors and study sites.
 Proactively plan and implement actions to improve study performance and quality.
 Manage suitable third parties for out-sourced services (such as clinical research organization, central laboratories, data management, statistical analysis) necessary for the preparation, initiation, operation and closure of clinical trial to ensure timely deliverables.
 Ensure clinical trials in compliance with Good Clinical Practice (cGCP) and ICH-GCP, Connect’s SOPs and other relevant clinical research guidelines by implementing quality control activities.
 Ensure the study cost within budget and in a reasonable way.
 Develop trial mitigation plans as necessary
 Anticipates, manages, and escalates issues as appropriate.

关键绩效指标KPI’s
 Delivery of clinical studies as planned timeline and milestone.
 Quality and compliance management.
 Budget management and budget control with ±5%.
客户Customers:
Regulatory affairs, pharmacovigilance, business development, finance.

支持部门Support Areas:
Medical science, biostatistics, data management, PV, RA
Discovery
Biologics & CMC
Finance
HR & Admin


职位要求Job Requirements:
Education:
 Bachelor or master degree in medicine, pharmacy or other life sciences.
 MD/Ph.D. is a plus.
 English CET 4 or equivalent, CET 6 is preferred.



Experience:
 At least 5-year in clinical operation.
 At least 2-year experience in clinical project management.
 Goold English skills in writing, reading and speaking.
 Good communication and interpersonal skills.
 Proficiency in computer skills.
 Availability to travel according project requirement.

直接下属Direct Reports:
NA
应聘要求
学历要求: 本科 专业类别: 不限
专业名称: 不限 户籍要求: 不限
适宜性别: 不限
年龄要求: 不限 工作经验: 5 年
外语能力: 英语 熟练 计算机能力: 不限
技能资质: 不限
其它要求: 不限
职位首次录入: 2018-11-26 15:01:48
职位二维码:
临床项目经理-苏州康乃德生物医药有限公司
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