Clinical Data Manager

Overview

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North Chicago, IL

• 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.

• Bachelor's degree in a health-related, scientific, or equivalent field.
• 58 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.