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(Lead) Clinical Data Manager (Remote)

Remote, MA Remote

Posted: 01/24/2023 Employment Type: Contract Job Category: Data Sciences Job Number: 539000 Is job remote?: Yes Country: United States

Job Description


Remote Anywhere in the US is fine for location.

•     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:
  • Approximately 10 years of clinical trial data management experience in the pharma/biotech industry.
  • Extensive technical experience using electronic data capture systems. Demonstrated experience with Oracle InForm.
  • 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).
Pay $95-105/hr based on experience
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