Contract Clinical Data Manager

Contract Clinical Data Manager

Contract through end of year then can renew

Position Summary:

The CDM contract position is an individual contributor role that provides Data Management support. The contractor is a self-motivated, collaborative clinical data management professional who is a self-starter that thrives in a fast-paced environment.

Responsibilities (including but not limited to):

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

•     Monitoring data management vendor quality of work through key performance metrics.

•     Maintain program level DM deliverable timelines in accordance with program development strategy. Escalates timeline issues, as needed.

•     Supports 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.

•     Interacts with external data vendors, develops data transfer agreements.

·        Supports 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.

Requirements:

·        Minimum 8+ years of clinical trial data management experience in the pharma/biotech industry.

·        Extensive technical experience using electronic data capture systems. Demonstrated experience with Medidata Rave.

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

·        Ability to adapt and manage competing and rapidly changing priorities.

·        Effective in proactively identifying issues and supporting teams in the development of creative solutions and compliant decisions.

·        Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment.

·        Ability to work independently and dependably meet project timelines.

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