Job Description

Job Description

Job Description

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

• 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).

The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

Company Description

The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

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