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Clinical Data Manager
Clinical Data ManagerKatalyst HealthCares & Life Sciences • New Haven, CT
Clinical Data Manager

Clinical Data Manager

Katalyst HealthCares & Life Sciences • New Haven, CT
30+ days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents.
  • Troubleshoot technical issues and design effective data review processes.
  • Manage Data Management tasks from study start-up to database lock for assigned studies.
  • Lead multiple large and complex studies, delegating tasks as needed.
  • Interact effectively with sponsors and oversee vendors.
  • Mentor junior personnel.
  • Develop SOPs and study-specific procedures.
  • Work with DB programmers to design (e)CRFs and edit checks in EDC systems.
  • Lead User Acceptance Testing (UAT) tasks for complex studies and modules.
  • Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation.
  • Manage queries and trends to ensure data completeness and integrity.
  • Perform coding of adverse events, medical conditions, and medications.
  • Prepare training materials and user guides for EDC data collection tools.
  • Provide study-specific training for team members and end users.
  • Implement technical solutions and resolve complex issues.
  • Provide regular status updates to cross-functional study teams, management, and sponsors.
  • Ensure archiving of study databases and related documents.
  • Organize and file study documentation.
  • Provide input to cross-functional study timelines and resource requirements.
  • Assist with identification of project scope changes.
  • Present at sales and marketing meetings for prospective clients.
  • Develop SOPs and manuals.

Requirements :

  • Minimum BS in a scientific or health-related field or equivalent.
  • Minimum + years of experience in Clinical Data Management.
  • Knowledge of medical terminology and pharmaceutical notation.
  • Expertise with EDC systems such as Medidata Rave, Informa, Medio.
  • Excellent organizational and time management skills.
  • Strong collaboration and leadership skills.
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    Clinical Data Manager • New Haven, CT

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