长沙招聘

1、Acts as the China/Regional
  Lead for the designated global/regional studies and assists the Senior
  Manager/Manager, Clinical Operations in the daily operational matters related
  to the execution, management and monitoring of the trials, such as review of
  informed consent forms, participating in site PSSVs, co-monitoring visits,
  close-out visits, drafting of these visit reports, review of IMP packages,
  etc. so as to ensure that the defined timelines and milestones are being met
  in a timely and efficient manner.

2、Assists
  the global/regional project teams to provide technical and content expertise
  within China/Asia Pacific region during the course of the study, as well as identifying
  potential challenges and working with team to strategize possible solutions.

3、Assists the Senior Manager of Clinical
  Operations in CDD to enhance process, functional and operational efficiencies
  in the clinical development of their designated global/regional trials
  through sharing of information, best case examples etc. within JAC PCU and
  across the different PCUs

4、Provides general CRO/vendor oversight in
  the management and progress of their designated global/regional trials in
  China/Asia Pacific region

5、Participates in projects and initiatives
  relating to better understanding of patient reality and hhc within area of
  work

6、Assist in the improvement of EPCS
  committees and processes.

· Working knowledge of entire drug
  development process, including clinical plan development and execution of
  entire clinical study chain, specifically within China/Asia Pacific region

· Detailed knowledge of Code of Federal
  regulations (CFRs), ICH guidelines, clinical operations, project management,
  and corporate /regional SOPs

· Demonstrated ability to manage and coach
  reports who are CRO project managers and individual contributors

· Good organizational, time management and
  attention to detail skills

· Extremely proficient computer skills
  including MS Word, Excel, and PowerPoint

· Strong verbal, written and interpersonal
  communication skills, especially needed to work effectively in a
  cross-functional and cross-cultural team environment, managing that team as
  required

· 4-5 Years of pharmaceutical and/or CRO experience
  in the capacity of a Project Lead / Project Manager

· Experience in handling multiple tasks

· Strong personnel management experience is
  required

· Bachelor’s degree required in associated
  scientific discipline

· Master’s degree, PhD, or RN degree preferred