Description
SUMMARY:Designs, implements and maintains clinical trial database for new and ongoing clinical research studies. Manages clinical database activities including: archiving of clinical data and clinical study databases, security administration, electronic data received from clinical trial sites and vendors, and the development of technical study documents such as annotated case report forms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Provide a high level of expertise in data management to support clinical studies.
* Manage data transfers with CRO's, SAE/AE reconciliation and Med DRA coding semi-automated processes.
* Support IND Reporting and the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
* Prepare recommendations for new or improved processes for data management and data flow.