Clinical Data Associate II
Core
Provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock.
Role type
Mid-level clinical data management associate
Builds
Clinical databases and data management documentation for assigned projects
Domain
Clinical research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Data entry, quality control, CRF specification development, database building, UAT, edit check specification, medical coding, SAE/AE reconciliation, vendor liaison, SAS programming assistance, protocol/SAP/CSR review
Preferred skills
Clinical, scientific, or healthcare discipline experience
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook), EDC systems, SAS
Responsibilities
Support Lead DM as backup/team member; perform data entry for paper-CRF studies; conduct quality control of data entry; develop CRF specifications; assist in building clinical databases; conduct database build UAT; specify requirements for edit checks; create and maintain data management documentation; train clinical research personnel; review and query clinical trial data; assist with line listing data review; run patient and study level status reporting; perform medical coding; assist with SAE/AE reconciliation; liaise with third-party vendors; assist with SAS programming QC; assist with protocol/SAP/CSR review; participate in SOP development; communicate with sponsors/vendors; present software demonstrations.
Seniority
Mid-level, hands-on IC