Clinical Data manager

Details for the position are as follows:

• 9-month contract to start with the possibility of extension or conversion depending on performance and business needs
• Rate: $55-65 an hour
• Location: Durham, NC

• The Clinical Data Manager is responsible for the oversight, management, quality review, and integrity of clinical trial data across multiple studies. This role applies expertise in clinical research, electronic data capture (EDC) systems, and clinical database management to support the collection, review, analysis, and reporting of clinical data in compliance with regulatory requirements and company standards. The ideal candidate will have hands-on experience with Veeva Vault EDC and CDB, strong analytical skills, and the ability to collaborate cross-functionally with internal teams and external vendors/CROs.
• Manage and oversee clinical data management activities throughout the lifecycle of clinical studies.
• Provide oversight and quality control (QC) review of data management deliverables performed by CROs and external vendors.
• Administer user access and permissions within Veeva Vault EDC.
• Create specifications for data review listings and develop custom listings within Veeva Vault CDB.
• Perform User Acceptance Testing (UAT) for Veeva Vault EDC and CDB enhancements, updates, and study builds.
• Document testing findings in electronic tracking logs and collaborate with study teams and vendors to resolve system or data-related issues.
• Design, review, and validate Case Report Forms (CRFs), clinical databases, edit checks, and data validation logic.
• Develop study-specific documentation including electronic Case Completion Guidelines (eCCG), Data Management Plans (DMPs), and workflow processes.
• Generate, track, and resolve data queries based on validation checks, discrepancies, and data review findings.
• Design and manage Data Transfer Specifications (DTS) for external data receipt, processing, reconciliation, and tracking.
• Process clinical data transfers including data receipt, verification, reconciliation, and documentation.
• Conduct quality control audits to ensure data accuracy, completeness, consistency, and compliance with SOPs, study protocols, and regulatory requirements.
• Monitor data management timelines, productivity, and quality metrics to support successful study execution.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Medical Monitoring, Programming, and external vendors to support study deliverable

• Bachelor’s degree in Information Systems, Computer Science, Life Sciences, or a related scientific or technical field required; equivalent combination of education and experience may be considered.
• Prior experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry preferred.
• Strong understanding of clinical research processes, GCP guidelines, and clinical data management principles.
• Hands-on experience with Veeva Vault EDC and Veeva Vault CDB required.
• Experience with database design, edit check development, data validation, and query management.
• Proficient computer skills and experience working with clinical systems and electronic databases.
• Strong attention to detail with the ability to manage multiple priorities in a fast-paced environment.