職位描述
CTACRCHGRCRA臨床數據分析藥品臨床研究新藥腫瘤研究
The Specialist, HGR Management is the entry level of HGR Management Team. He/She is responsible for supporting the related activities in HGR application submission, HGR process management and excellence, compliance oversight and inspection readiness.
· Support on HGR application
submission, including but not limited to on-line submission, site filing,
tracking and application form, format review based on study need in a timely
manner.
· Implement HGR strategy at operation level to keep low
rejection rate and good compliance in line with the regulation and internal
process.
· Support to oversee HGR compliance
during study execution, including but not limited in HGR
submission application, HGR quality issue, study remaining sample retention.
· Responsible for HGR
self-check, audit, inspections on study level and relative report format
management.
· Responsible for authority contact and consultation, conduct
the HGR regular refreshing training.
· Support the development and upgrade the internal used
HGR system.
· Support to the development and update of HGR SharePoint as end to end tools with process excellence mindset.
· Key person for HGR submission accounts maintenance, and other tasks assigned by line manager.
工作地點
北京朝陽區平安國際金融中心A座
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職位發布者
郭玉玲/人事經理
昨日活躍立即溝通
愛恩康臨床醫學研究(北京)有限公司At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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