Experience

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  Huajin pharmaceutical company

  Jul 2011 - Aug 2012

  Technician

  In charge of analysing pre-production drugs with various methods and instruments.Strictly followed the pharmacopeia, GMP and company SOPs.

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  Sanofi

  Sept 2012 - Aug 2015

  Study data manager

  Take responsibility for or support data clean activities in many global studies of oncology, cardiovascular and diabetic diseases. The tasks included but were not limited to query management, edit check testing, SAE/PK/LAB/IWRS reconciliation, listing review, patient profile review, medical review, DVP updates.Provide training. Mentored new staff and performed quality control.

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  Otsuka beijing research institute

  May 2016 - Apr 2017

  Dm specialist

  Oversight outsourced DM tasks for all studies.Review and approve CRF and DM documents from study start-up to database lock. Coordinate team member’s review and UAT testing.Review and compare vendors’ quotations for the selection of EDC and CRO.Closely involved in the whole process from IND to NDA. Make contribution to review other functions’ documents such as Protocol, SAP, SAR, CSR, PD specs, MM plan, etc. Co-ordinate statistician’s work with CRO.Work in the whole process from self-inspection to CFDA inspection at many sites.Attended bid-defense meeting, kick-off meeting, INV meeting, data review meeting.Summarize Otsuka’s convention, requirements, templates and pass them to CRO. Ensure the quotations and scope or works are consistent with Otsuka’s requirements.Serve as the primary point of contact for many systems, tools and databases with headquarter. Coordinate the access applications and deliver the training.Maintain internal tracking systems and eTMF. Show less

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  Johnson & johnson

  Apr 2017 - Sept 2017

  Senior specialist, clinical data management

  Provide task-based support to oversight CRO DM’s work.Perform quality control on the data content, structure and mapping in the form of SDTM from trial conduct to database lock.Archive in and maintain the sharepoint and vTMF.

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  George clinical

  Sept 2017 - now

  Data manager ⅱ

  Full hands-on work of data management at studies’ start-up, conduct and close-out.In charge of or support DM activities for all commercial and academic studies in GC.Coordinate between lead PI, EDC vendor, sponsor (global PM and DM) to solve issues and come to decisions for matters in all aspects as lead DM in China. Oversight of vendor’s work including UAT testing and the mapping of two systems.Coding with MedDRA and WhoDD in different EDC systems, both on-line and off-line.