TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Data Manager

Department :  CD&RA
Working place :  Suzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  3
Minimum academic :  Bachelor
Release time :  08 Jul, 2021
Job Responsibilities
  • • Communicate and coordinate with the study team and applicable external vendors

  • • Provide operational leadership of data management tasks for assigned studies from start-up to close-out (including but not limited to eCRF design & edit checks, UAT, data management plan, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock).

  • • Ensure adequate documentation and application of internal and industry standards/best practices across studies.

  • • Oversee CROs and vendors for all data management related activities, providing consistent team direction/guidance and monitoring quality of work through key performance metrics.

  • • Represent Data Management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.

  • • Participate in Data Management department infrastructure, by contributing to SOPs/work instructions development, CRF standards development and cross-functional process improvement initiatives.

  • • Support Study Management and Contracts on budget-related activities.

Job Requirements
  • • At least 3 years of experience in data management is required and a BA/BS degree is required.

  • • Extensive technical experience using EDC systems (ideally Medidata RAVE) and MS Office products.

  • • In-depth knowledge of DM industry standards, best practices and CDISC implementation (CDASH, ODM, SDTM).

  • • Ability to perform all job functions with minimal to no direct supervision and possess a full understanding of all aspects of data management.

  • • Excellent written, verbal and organizational skills.

  • • Good project management skills.

  • • Good team collaboration.