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

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 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

Job Tags

For contractors, Remote job,

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