Data Analyst (Clinical) - $5.5K to $6K
Recruit Express Pte Ltd| Date Posted: 21-Jul-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
Bachelor's / Honours
- Plan and execute data management workflow for pre-clinical studies and ensure that all necessary data quality control measures are in place. Coordinate with all laboratories, study and senior management to support regulatory submissions by using FDA-compliant systems
- 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.
- Min Bachelor's degree in Engineering or Science with at least 2 years’ of related experience in a regulated environment, preferably in life sciences.
- Experience in data analysis
Interested candidates, please forward your resume to [Click Here to Email Your Resume]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
Recruit Express Pte Ltd