1、Demonstrates the ability to manage or perform skills across the entire life cycle of clinical studies for medical devices and pharmaceuticals in China. Including but not limited to protocol development, site selection, IRB/EC approval, study initiation, monitoring, AE/MI reporting, clinical data management and  reporting/closure；
2、Management of study programs, individual study sites and/or CROs； 
3、Understands basic legal and regulatory obligations applicable in key countries across FMC AP operations to assist with the development and execution of regulatory studies；
4、Comprehensive understanding of the regulations for clinical research in China including a solid understanding of the SFDA requirements regarding clinical trials for product registration and PMS/Vigilance；
5、Management of the investigator initiated study (IIS) program in China and support of the regional program；
6、Assessment and critique of study proposals for company sponsored and investigator initiated studies；
7、Assists in the management of the approval process for IIS and participate in the clinical research review committee for FMC AP；
8、Monitors progress and deliverables of IISs , including the management of the FMC AP clinical trial database；
9、Maintains the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice；
10、Reports outcomes to the department head, management, investigators and other relevant bodies and assist with preparation of internal and external publications； 
11、Operating Policies and Procedures oversight；
12、Supports development, implementation and maintenance of relevant policy and procedure documents as needed；
13、Supports adaption of regional guidance to local country environment with focus on China；
14、Liaison to country Medical/Clinical functions for study related issues；
15、Liaison with FMC AP R&D department at the Jiangsu plant to support clinical research related to R&D projects。

1、University Graduate with a degree in medicine, pharmacology / pharmacy, biosciences or other health sciences. MD or PhD is a plus；                            
2、The position requires that the candidate should have at least 5 years work experience in clinical research / CRO (academia or industry), medical or scientific affairs or medical/clinical practice in a field closely related to dialysis/ nephrology. There should be a constant strive for continues learning and knowledge growth；
3、Interpersonal skills necessary to communicate with internal and external personnel, strong oral and written communication skills in English and Mandarin since the focus of this position will be on the China market and the greater China region；
4、He or she is willing to travel extensively in China and occasionally throughout Asia-Pacific。