TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company
Transcenta, biologics, antibody
• 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.
• 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.