Job Description

A recognized pharmaceutical company has a great Remote opportunity awaiting a new Clinical Data Manager. In this role, the Clinical Data Manager will be responsible for contributing Data Management Support for assigned programs. The contractor is a self-motivated, collaborative clinical data management professional who is a self-starter and thrives in a fast-paced environment.

Responsibilities:

• Work with the 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 the 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
• Draft eCRF design and edit check specifications; supports cross-functional review
• Perform cross-functional sponsor EDC user acceptance testing
• Interact with external data vendors and develop data transfer agreements
• Support the development and implementation of key data and metrics reports/listings
• Draft and review DM essential documents, including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans, and DB Go Live and Lock documentation

• 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
• Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Projec,t and Outlook)
• 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
  

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