关于职位

基本信息

城市: 上海

工作时间: 全职

职能类别: 医疗健康

资历: 有经验的专业人士

管理经验:

招聘官: Craig LIN | Craig.LIN@danone.com

岗位职责和要求

岗位职责:

The Clinical & Digital Health Evidence Manager will work within the Clinical & Digital Health Evidence Team in China.

 The Clinical & Digital Health Evidence Manager is responsible for the operational management of (complex) clinical studies with nutrition in China in a Real World Evidence and Dencetralized Trial setting .  This includes preparation, initiation, conduct, progress reporting and closure of the studies according the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures. He or she will be responsible for the operational feasibility of the protocol and translate the clinical study protocol to the clinical study plan. He or she is like the spider in the web of a multi-disciplinary team, leading the clinical project  team and responsible for ensuring  the quality, timeline and budget of the clinical studies. In addition, he or she will be responsible for the selection and management of external vendors  for example suppliers, sites and CRO’s.

 

Responsibilities include:  

       Leading the conduct of clinical projects from the start to the end in accordance with protocol, Good Clinical Practice, SOPs and local regulation /legislation.

       Coordination in the preparation, execution and data management /analysis phase.

       To assess operational feasibility of the protocol

       Responsible for evaluation and selection of (potential) investigators

       Coordinate selection of third parties (CRO’s, warehouses, central labs, etc) involved in research projects.

       Manage the CROs and other vendors at research project study level and monitor quality of the vendors.

       Develop study documents (Protocol,  ICF, CRFs,  etc.)

       To conduct  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 and third party contracts and payments.

       Coordinate the process of data management and statistical analyses.

       Reviewing and further develop local operation procedures

The Clinical & Digital Health Evidence Manager is ultimately responsible for the quality of work as delivered by the entire multidisciplinary project team (including vendors) with regards to ICH/GCP, timelines and budget.

 

The Clinical & Digital Health Evidence Manager is expected to show  clear leadership, have  a pro-active approach, drive project progress and can clearly contributes to further development of the team and the ways of working.

       At least 5 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.

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

       Experienced in Project Management

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

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

      Openess for  trial designs adapted  for nutrition industry utilizing Digital Health technology

 

Preferences:

       Experience with Real World Evidence projects and/or fully digital or remote studies  

       Professional experience in the area of maternal & child healthcare nutrition

•     Experience in Health Economics