职位详情

Clinical Protocol Manager Country Lead - 中国区临床方案负责人- 上海

面议

上海静安区 5-10年 本科
中美上海施贵宝制药有限公司

医药企业 其他 规模不详

职位描述
Experiences Desired
 Demonstrate******** of the operational process for the development ofPhase IV, BMS Sponsore********, Investigator Sponsore********an********-Marketing Surveillance Research
 Responsible for oversight an******** of budgets for all researchoperationalize******** OCPO within China
 Demonstrate******** in budget management
 Oversees the OCPO research processes to ensure study timelinesan******** are met appropriately.
 Manages all aspects of research assigne******** start to finish
 Demonstration of strong Project an******** management skills
 Demonstrate******** an******** able to manage studies acrossorganization ( i.e. multiple TAs an******** portfolio of research)
 Ensures global standardize******** are followe******** the managementof OCPO manage********
 Provide country feedback on OCPO study operating model
 Ensures country diversity an******** needs (regulat******** languages,tools are considere******** all aspects of research operations as wellas policies an********
 Reviews an******** important study documents such as CRFs, monitoringplans, training ******** etc.
 Coordinates or contributes to key clinical documents (e.g. Protocols,Protocol Template********).
 Works with outsourcing group to formalize vendor Request for Proposals(RFPs) to ensure accuracy of operational details
 Manages Contract Research Organizations (CROs) or external vendorrelationships
 Ensures OCPO Global an******** team maintain strong transparentrelationship with global procurement
 Ability to identify potential barriers to study completion an********effective strategies that facilitate study conduct.
 Demonstrate******** to manage Sponsor-Investigator research, monitorstudy progre******** enrollment an******** establishe******** t********demonstrating strong capabilities in appropriate proactive interventionwhen necessary.
 Participates in interactions among many different groups includingFiel******** Sc******** Medical Strategy, , Biomarker Team, GPV&E,Regulatory, labs, principal scientists an********
 Enhances transparency an******** sharing between OCPO Globalan********
 Demonstrate******** an******** to change.
 Computer literate an******** to operate independently within anenvironment that relies heavily on technology for information an********tool.
 Experience working within the pharmaceutical industry.
 Demonstrate******** to multi-task an******** high performance demands.
 Fluency in both English an******** languages written an********.

Knowledge Desired
 Minimum education BA/BS.
 Prefer individual with strong science background, Nurse, PA, NP, PharmD, PhD
 Knowledge of general clinical research including its processes,procedures an********.
 Knowledge of the pharmaceutical industry an******** stu******** PhaseIV, BMS Sponsore******** an******** components.
 Knowledge of goo******** practices (GCP) an******** Guidelines.
 Knowledge of an******** experience with CFDA woul******** a distinctadvantage.
职位要求
  • 专业要求: 不限
  • 最低学历: 本科
  • 工作年限: 5-10年
工作地点
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