达能中国

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.