临床项目经理 (651861)
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: |
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住房食宿: |
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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
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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 |
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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: |
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