Clinical Data Manager

Clinical Data Manager Overview The Clinical Data Manager will oversee clinical data processes, ensuring accuracy and compliance throughout the data lifecycle. Collaborate with cross-functional teams to integrate data management activities and enhance operational efficiency. Design, implement, and manage data deliverables from study start-up to close-out. Stay updated on emerging technologies and industry trends to improve data management practices. Ensure compliance with industry standards, regulations, and guidelines for clinical data management. Provide leadership and support for data management teams, ensuring quality and timely deliverables. Develop and maintain comprehensive study documentation and specifications. Perform quality control on deliverables and ensure adherence to best practices. Clinical Data Manager Key Responsibilities & Duties Act as the primary data management representative for client and sponsor interactions. Define specifications and collaborate on configuring data cleaning strategies and oversight activities. Perform holistic data reviews and trending analyses to identify issues and develop mitigation strategies. Monitor and interpret key performance indicators for process improvement. Prepare and maintain data management documentation throughout the trial lifecycle. Ensure compliance with quality standards, regulations, and clinical trial methodologies. Lead data management activities for assigned studies, ensuring successful execution.Collaborate with technical teams to enhance data management systems and tools. Clinical Data Manager Job Requirements Bachelor’s degree in a relevant health science or scientific discipline preferred. 5+ years of experience in the pharmaceutical or biotechnology industry with clinical data management. CCDM Certification is preferred. Proficiency in Microsoft Office, EDC systems, and clinical data management tools. Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies. Experience with cloud SaaS platforms, data reporting tools, and RBQM methodology preferred. Strong project management, analytical, and strategic thinking skills. Excellent collaborative and communication skills, both verbal and written. #J-18808-Ljbffr Greenkey Resources LLC