Job Description

• 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.

• Minimum 3+ 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).

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