武汉 [切换城市] 武汉招聘武汉生物/制药/医疗器械招聘武汉医药技术研发管理人员招聘

临床数据项目经理(DML)

PPC佳生

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-10-23
  • 工作地点:上海-黄浦区
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位月薪:1.5-2.5万/月
  • 职位类别:临床数据分析员  医药技术研发管理人员

职位描述


  

  1. Requirements

    Responsible for planning, execution, and delivery of Clinical Data Management projects on schedule and within budget, and within PPC and/or sponsor Standard Operating Procedures (SOPs).

  2. Responsibility

    1. Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.

    2. Develop and implement project plans for relevant Data Management projects.

    3. Serve as Data Management Lead on selected projects

    4. Create project specific Data Management Plans (DMPs)

    5. Preparations of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification under the support of CDAs.

    6. Assist with and/or oversee the creation of test data for entry screens and edit checks

    7. Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan

    8. Participate/attend Sponsor requested meetings as required

    9. Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections

    10. Perform other duties as required by the Department.

  3. qualifications and experience

    1. BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education

    2. 4-6 years of experience including proven ability to lead data management activities

    3. Effective communication skills

    4. Ability to drive and oversee a cross-functional team via effective delegation and team workload assignment

                                      


公司介绍

PPC佳生集团(PPC Group)是一家成立于1997年的临床CRO公司。总部设立于上海,并分别在台北,徐州,北京,南京,首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今,PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目,其中涉及24个主要研究领域。
     另外,PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年,PPC佳生在台北(MacKay Memorial Hospital)建立了***家专属I期临床研究中心;2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心;2018年,PPC佳生又分别与徐州市中心医院,湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前,PPC佳生已有5家自主运营的I期临床中心。

联系方式

  • Email:mavis.yao@ppccro.com
  • 公司地址:地址:span朝阳门外大街18号(丰联广场)