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 individual contributor clinical data manager
Builds
Clinical databases and data management documentation
Domain
Clinical research / Healthcare
Required skills
Data entry, Quality control, Database development, CRF specification, Edit check creation, Medical coding, SAS programming assistance, Vendor liaison, Protocol/SAP/CSR review, SOP development
Preferred skills
Clinical/scientific/healthcare discipline experience
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook), EDC systems, SAS
Responsibilities
Support Lead DM as backup, 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 in 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, troubleshoot operational problems, review protocols/SAP/CSRs, participate in SOP development, communicate with sponsors/vendors, present software demonstrations.
Seniority
Mid-level, hands-on IC
