Participate in CDS activities including data review and query management, assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
Ensure work carried out in accordance with applicable SOPs and working practices.
Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
Ensure operational excellence in collaboration with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities
Work Location Assignment: Hybrid