Purpose of the Job and Expected outcome
Configure the Laboratory Information Management System LIMS dbase throughout the duration of the study inline with the Clinical Protocol, performing appropriate QC controls according to global procedures and agreed specifications. Ensure that the electronic data generated is transferred to the customer as per the Data Specifications.
Key Accountabilities Data Configuration Specialist supports activities for studies during all stages in such a way that:
Tasks have been carried out independently, and the status or result is communicated back to all relevant parties.
Database to be set up as per client protocol.
Configure the study-specific requirements in the (LIMS) for central laboratory testing in clinical trials
(e.g. visit schedule, testing panels and flagging).
Collaborate with project management, laboratory, IT and clients.
Is aware of key study milestones and prioritizes study activities to achieve the timelines.
Format the Database as per desired type of data.
Ensure that LIMS and other systems are correctly configured in line with study Priming Document.
Maintain complete and current version controlled Data Study Files.