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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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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.
Responsibilities:
Requirements:
Clinical Data Manager
Remote, MA US
Posted: 05/14/2025
2025-05-14
2025-06-14
Employment Type:
Contract
Job Category: Data Management
Job Number: 4434
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.
Responsibilities:
- 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).