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Data Compliance Specialist

Job Details

Location
Singapore
Salary
Competitive package with comprehensive benefits
Job Type
Permanent
Ref
BH-159284
Contact
Joanne Koo
Posted
about 1 year ago
Data Compliance Officer
  • Single contributor
  • State-of-art research facilities
  • Based in Singapore
Our client is a leading player in the development and scientific assessment of reduced-risk products (RRPs).
 

PURPOSE

The Data Compliance Specialist will be tasked to plan and execute data management workflow for pre-clinical studies and ensure that all necessary data quality control measures are in place. He/She will coordinate with all laboratories, study and senior management to support regulatory submissions by using FDA-compliant systems.
 
JOB RESPONSIBILITIES
  • Coordinate and check the electronic data for non-clinical studies which may be used for regulatory submissions whilst ensuring compliance with relevant regulations
  • Review and develop documents for assigned studies, such as Study Plan, Study Endpoint Inventory List, Validation Specification, Data reviewers Guide and others as applicable or assigned
  • Manage the Non-Clinical Data Management databases to generate datasets and review for errors & warnings
  • Support the internal data clarification process which includes data validation checks & maintaining the data clarification log after receipt of the data from internal and external sources
  • Continuous improvement on documentations, such as data management plans, data validation plans, standard operating procedures, work instructions, and any others as required or requested in coordination with all applicable personnel
  • Implement and enforce regulatory requirements for the internal Standard Exchange Nonclinical Data (SEND) library so that data developed for regulatory submissions are compliant and correspond with the controlled terminology in the SEND Library. This includes acting as the subject matter expert to expand and maintain the SEND Library
  • Coordinate with study directors, study personnel, database programmers, regulatory and project management staff, and other relevant personnel to assure that the data management system and processes meet user and study requirements
  • Coordinate and document the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from external laboratories or Contract Research Organisations) including a seamless process to encompass this data for regulatory submissions according to the relevant external and internal guidelines

REQUIREMENTS
  • Bachelor Degree in Engineering or Science
  • Minimum 2 years of related experience in a regulated environment, preferably in life sciences
  • Strong initiative and organizational and communication skills with demonstrated capability of working on multiple projects at one time
  • Ability to complete deliverables on time and adjust priorities in a fast-paced environment, and able to work independently as well as collaboratively in a team environment
  • Excellent verbal and written communications skills
  • Experience working with MS Office Suite (Excel, Word and PowerPoint) and possess familiarity with MS Project
  • Experience working with Provantis and/or PathData is desirable and a plus
 
 
Reg No. R1109555
BeathChapman Pte Ltd
Licence no. 16S8112