CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier ChinesePharmaceutical company listed in Hong Kong Stock Exchange withoncology-dominated innovative product portfolio and international growthstrategy. CSPC is looking for a full time Global Clinical Study Manager(GCMS) to manage ongoing and future clinical studies to be conducted inUS.
Working with the Clinical Project Managers (CPM) in US, theGCMSisresponsible for the execution of clinical trialsto be conducted in US,EU and Japanwith focus on the following responsibilities:
Responsibilities: • Review clinical data on a routine basis to ensure the quality ofclinical studies • Provide medical assessments on safety events and trial related data • Generate and/or review all the documentsnecessary for studyinitiation, such as but not limited to, protocol, CRF, IB, etc. • Review all the documents related to study result publication, such asbut not limited to, TFLs, CSR, manuscripts, etc. • Contribute to NDA preparationand submission in US, EU and Japan, byworking with global regulatory team and local medical group • Maintain routineand efficient communication with global team forongoing studies • Ensure compliance with international GCP guidelines/regulationsandcompany SOPs • Participate in quality assurance activities and coordinate resolutionof audit findings • Ensure audit-ready condition of clinical trial documentationsincluding TMF • When needed, contribute to other company related business, such as butnot limited to, in-licensing candidate evaluation, KOL management, etc.
Requirements: • Medical degreeis required • Minimum of 8 years ofclinical research experience • Hands-on experience with NDA preparation in US, EU and Japan • Knowledge of GCP, ICH guidelines and regulatory requirements forclinical research • Excellent English communication skills (both verbal and writing) • Strong organizational skills with problem solving and team buildingskills • Ability to handle a high volume of tasks within a given timeline • Ability to build relationships within and between the organizations
Location: Beijing, China Report to: Head of Global Clinical Development and Regulatory Affairs Working time: 40 hours per week. Pay and Benefits: Attractive salary with comprehensive benefit package
If you are interested, please send your CV to email@example.com