職位描述
職位描述：
1.Actsas the China/Regional Lead for the designated global/regional studies andassists the Senior Manager/Manager, Clinical Operations in the dailyoperational matters related to the execution, management and monitoring of thetrials, such as review of informed consent forms, participating in site PSSVs,co-monitoring visits, close-out visits, drafting of these visit reports, reviewof IMP packages, etc. so as to ensure that the defined timelines and milestonesare being met in a timely and efficient manner.
2.Assiststhe global/regional project teams to provide technical and content expertisewithin China/Asia Pacific region during the course of the study, as well as identifyingpotential challenges and working with team to strategize possible solutions.
3.Assists the Senior Manager/Managerof Clinical Operations in CDD to enhance process, functional and operationalefficiencies in the clinical development of their designated global/regionaltrials through sharing of information, best case examples etc. within CDD andacross the different PCUs
4.Provides general CRO/vendoroversight in the management and progress of their designated global/regionaltrials in China/Asia Pacific region
5.Participates in projectsand initiatives relating to better understanding of patient reality and hhcwithin area of work
6.Assist in the improvementof EPCS committees and processes, wherever possible.
Qualificationsand Expertise
· Working knowledge of entire drug developmentprocess, including clinical plan development and execution of entire clinicalstudy chain, specifically within the China/Asia Pacific region
· Detailed knowledge of Code of Federalregulations (CFRs), ICH guidelines, clinical operations, project management,and corporate /regional SOPs · Demonstrated ability to manage and coachreports who are CRO project managers and individual contributors · Good organizational, time management andattention to detail skills · Extremely proficient computer skillsincluding MS Word, Excel, and PowerPoint Strong verbal,written and interpersonal communication skills, especially needed to workeffectively in a cross-functional and cross-cultural team environment, managingthat team as required
