1、To prepare the new drug development budget and resource for clinical study execution.
2、In terms of DD annual goal of development, participate in Clinical annual development plan and resource budget for responsible study.
3、To be responsible of individual study quality control and management, ensure clinical study execution strictly following with study protocol, relevant SOPs and China regulation, oversight clinical study initiation, execution and completion, coordinate the efficient communication within internal and external team member.
4、Work with team member to complete study protocol, IB, ICF, and relevant study report, etc.
5、To be involving in external collaborator selection by request, and deliver the training and oversight CRO/SMO performance;
6、To keep the efficient communication and setup the good relationship with study investigators.
7、To coordinate with relevant function and make its supporting and collaborating work.
8、To take on other works assigned by line-managers.
9、Experienced manager provide coaching and mentorship to junior manager/execution as needed, take oversight of their clinical trials’ execution.
1、Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field
2、At least 4 years’experience in clinical research in pharmaceutical industry or CRO, with at least 1 years’ experience in project management for manager level candidate ; and at least 3 years’ project management experience for senior manager level candidate; pharmaceutical experience is preferable
3、Fluent English listening, speaking, reading and writing skills
4、Leadership: strong communication and presentation skill; Ability to organize and coordinate the teamwork
5、Be proficient in Word /Excel/Power Point applying in project management