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
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).
Responsibility
Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.
Develop and implement project plans for relevant Data Management projects.
Serve as Data Management Lead on selected projects
Create project specific Data Management Plans (DMPs)
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.
Assist with and/or oversee the creation of test data for entry screens and edit checks
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
Participate/attend Sponsor requested meetings as required
Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
Perform other duties as required by the Department.
qualifications and experience
BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education
4-6 years of experience including proven ability to lead data management activities
Effective communication skills
Ability to drive and oversee a cross-functional team via effective delegation and team workload assignment
公司介绍
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)