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Katalyst HealthCares & Life Sciences
Clinical Data ManagerKatalyst HealthCares & Life Sciences • Atlanta, GA
Clinical Data Manager

Clinical Data Manager

Katalyst HealthCares & Life Sciences • Atlanta, GA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines.
  • Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities.
  • Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.
  • Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.
  • Support data cleaning and validation activities to ensure completeness and accuracy of study data.
  • Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.
  • Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.
  • Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies.
  • Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).
  • Supervise and provide guidance to junior CDM staff on assigned studies.
  • Perform additional CDM-related duties as required.
Requirements:
  • Bachelor's degree in a health-related, scientific, or equivalent field.
  • years of experience in Clinical Data Management role.
  • Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.
  • Hands-on experience with multiple Electronic Data Capture (EDC) systems.
  • Familiarity with additional CDM tools and analytics platforms preferred.
  • Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.
  • Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.
  • Excellent written and verbal communication skills.
  • Strong organizational skills with keen attention to detail.
  • Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.

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Clinical Data Manager • Atlanta, GA

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