Medical Operation Leader
主要工作職責(基本概況,主要功能,權限等)
General Summary(基本概況)
The overall purpose of the position is to
Provide support to post market studies, includes overall study management, vendor management and administrative activities in compliance with applicable legislation, company policy and SOP.
If applicable, manage and develop direct reporters, provide coaching, training, and guidance as needed.
Responsibility(工作職責)
? PMS Project Management:
1) Set up and lead the project team to ensure the PMS project is implemented according to company policy, SOP and relative regulations, ensure the project is conducted on time and within budget.
2) Lead the project team to accomplish the proposed timeline and on budget
3) Communicate with internal and external customers in terms of project progress and outstanding issues
4) Work closely with Medical Affairs partner on the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents development
5) Actively guide and coach study team members and perform co-visits as needed.
6) Coordinate with data manager, statistician and medical writer to generate the statistical report and study report, if applicable
Other responsibilities defined in written procedures.
流程中規定的其它職責。
Principle Relations ( inside &outside company) 主要工作關系(公司內部和外部)
– Medical affairs team in China, regional, and source companies
– IIS team, regional and source company
– Finance business partners
– HCC business partners, DD team partners
– Procurement business partners
– Business team, incl. marketing and leadership team
– Clinical research team in China, regional and source companies
– Clinical Quality Control/Assurance team in China, regional and source companies
– Key opinion leaders and investigators