Clinical Data Manager

• 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. Qualification Requirements: • Bachelor’s degree in a health-related, scientific, or equivalent field. • 5–8 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. Job Types: Full-time, Contract Pay: $75,000.00 - $100,000.00 per year Work Location: Remote Apply tot his job