Clinical Data Manager I

4 weeks ago


Cambridge, Massachusetts, United States Prometrika LLC Full time
Job Overview

Prometrika LLC is seeking a highly skilled Clinical Data Manager I to join our team. As a key member of our clinical operations department, you will be responsible for managing data for assigned studies, ensuring data integrity and quality.

Key Responsibilities:

  • Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, and CRF Completion Guidelines.
  • Work with DB programmers to design and edit checks in EDC systems.
  • Develop test scripts and test data for User Acceptance Testing (UAT).
  • Perform and document database and report UAT.
  • Receive, integrate, and reconcile electronic data.
  • Perform data review via listings and EDC systems, issue and resolve queries.
  • Manage queries to ensure data completeness and integrity.
  • Review medical coding listings.
  • Assist with data listing design for data review.
  • Perform SAE reconciliation.
  • Prepare training materials and user guides for EDC data collection tools.
  • Participate in client and team meetings as required.
  • Design, generate, and review status metric reports as needed.
  • Perform archiving of study databases and related documents.
  • Provide input to timelines to ensure timely completion of assigned tasks.
  • Provide regular status updates, keep the team and management informed of any changes.
  • Organize and file study documentation.
  • Work with management and senior DM personnel to implement technical solutions and resolve issues.

Requirements:

  • Minimum BS in a scientific or health-related field or equivalent.
  • Minimum 2 years of experience in Clinical Data Management.
  • Expertise with EDC systems, such as Medidata Rave, InForm, Medrio.
  • Excellent communication and time management skills.

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