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. #J-18808-Ljbffr Katalyst HealthCares & Life Sciences
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