Clinical Data Manager

A pharmaceutical company in Massachusetts is currently seeking a new Clinical Data Manager to provide Data Management support for assigned programs.

Responsibilities:

• Work with Clinical Data Management (CDM) Lead to support operational activities for one or more programs


• Monitor data management vendor quality of work through key performance metrics


• Maintain program level DM deliverable timelines in accordance with program development strategy


• Support data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks


• Drafts eCRF design and edit check specifications; supports cross-functional review


• Perform cross-functional sponsor EDC user acceptance testing


• Support development and implementation of key data and metrics reports/listings


• Drafts and performs review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans and DB Go Live and Lock documentation

Qualifications:

• 8+ years of Clinical Trial Data Management experience in the Pharma / biotech industry


• Extensive technical experience using electronic data capture systems


• Demonstrated experience with Oracle Inform


• In-depth knowledge of DM industry standards, best practices and CDISC/CDASH implementation


• Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook).


• Demonstrated excellent verbal/written and interpersonal skills


• Ability to work independently and dependably meet project timelines