A Full TimePosition forGlobal Clinical Study Manager

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier ChinesePharmaceutical company liste******** Hong Kong Stock Exchange withoncology-dominate******** product portfolio an******** growth strategy.CSPC is looking for a full time Global Clinical Study Manager (GCMS) tomanage ongoing an******** clinical studies to be conducte******** US.

Working with the Clinical Project Managers (CPM) in US, theGCMSisresponsible for the execution of clinical trialsto be conducte********US, EU an******** focus on the following responsibilitie********

Responsibilitie********

Responsibilitie********
• Review clinical data on a routine basis to ensure the quality ofclinical studies
• Provide medical assessments on safety events an******** relate********
• Generate and/or review all the documentsnecessary for study ********such as but not limite********, protocol, CRF, IB, etc.
• Review all the documents relate******** study result publ******** suchas but not limite********, TFLs, CSR, manuscr******** etc.
• Contribute to NDA preparationan******** in US, EU an********, byworking with global regulatory team an******** medical group
• Maintain routinean******** communication with global team for ongoingstudies
• Ensure compliance with international GCP guideline******** companySOPs
• Participate in quality assurance activities an******** resolution ofaudit findings
• Ensure audit-ready condition of clinical trial documentationsincluding TMF
• When nee******** contribute to other company relate********, such asbut not limite********, in-licensing candidate evaluat******** KOLmanagement, etc.

Requiremen********
• Medical degreeis required
• Minimum of 8 years ofclinical research experience
• Hands-on experience with NDA preparation in US, EU an********
• Knowledge of GCP, ICH guidelines an******** requirements for clinicalresearch
• Excellent English communication skills (both verbal an********)
• Strong organizational skills with problem solving an******** buildingskills
• Ability to handle a high volume of tasks within a given timeline
• Ability to buil******** within an******** the organizations

Location: Be******** China
Report to: Hea******** Global Clinical Development an******** Affairs
Working time: 40 hours per week.
Pay an**************** Attractive salary with comprehensive benefitpackage

If you are ******** please sen******** CV to ********