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招聘应聘:
招1人;当前0人应聘
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月薪水平:
面议
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职位类别:
其它
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工作地点:
太仓城厢
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工作性质:
全职
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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