关于职位

基本信息

城市: 上海

团队: 纽迪希亚生命早期营养品管理(上海)有限公司

工作时间: 全职

职能类别: HCN

资历: 有经验的专业人士

管理经验:

招聘官: Lucy FU | lucy.fu@Danone.com

岗位职责和要求

岗位职责:

  • Leading the conduct of clinical trials including the design, initiation, overall progress and reporting of these  trials in accordance with protocol, Good Clinical Practice, SOPs and local regulation and legislation.
  • Coordination of  the preparation, execution and data management /analysis phase.
  • To assess operational feasibility of the protocol
  • Evaluation and selection of (potential) investigators
  • Selection of third parties (CRO’s, warehouses, central labs, etc).
  • Management of  CRO/other vendors at research project study level and monitor quality of the CRO/other vendor.
  • Development of study documents (Protocol, Informed consent, CRFs,  etc).
  • Perform selection visits and co-visits with the CRO for initiation, monitoring  and close-out of sites
  • Arrange for regulatory and Ethics submission and approval.
  • Manage the project budget and site/third party contracts and payments.
  • Coordinate the process of data management and statistical analyses.

岗位要求:

         At least 4 years of experience in clinical research, primarily compromising of clinical project management, in China but under a regional or global R&D environment in the (bio-) pharmaceutical or medical devices or nutrition industry.

         Knowledge of conducting clinical studies according to ICH-GCP guidelines and local regulation and legislation.

         Excellent communication skills and responsiveness to interact with a multidisciplinary project team at Danone and with all other external parties involved.

         Experienced in Project Management

         Excellent networking skills in both the academic as well as the local and international biz environment

         Bachelor, Master, MD or PhD degree in a life science, nutrition or related scientific discipline. Clinical medicine background preferred.

         Fluent in English

         Preferably an affinity with Real World Evidence,  innovative designs and digital tools in Clinical studies  

         To be able to work independently and  effectively in a multidisciplinary environment with competing priorities.

         Preferably professional experience in the area of maternal & child healthcare nutrition.