Clinical Data Manager Overview • The Clinical Data Manager role offers a fully remote opportunity, requiring expertise in clinical data lifecycle management and adherence to EST hours. • Collaborate with cross-functional teams to integrate data management activities and enhance operational efficiency in clinical trials. • Utilize industry standards and regulatory requirements to design, implement, and manage data deliverables from start-up to close-out. • Stay informed on emerging technologies and industry trends to implement best practices for effective data management. • Provide leadership in data management processes, ensuring quality deliverables within approved scope and timelines. • Engage in holistic data review and trending analysis to proactively identify issues and develop mitigation strategies. • Prepare and maintain comprehensive study documentation throughout the trial lifecycle, ensuring compliance with industry standards. • Support client and sponsor interactions, acting as a primary representative for data management activities. Clinical Data Manager Key Responsibilities & Duties • Act as the lead data manager for assigned studies, ensuring adherence to timelines and quality standards. • Define specifications and collaborate with technical teams for data cleaning strategies and oversight activities. • Perform quality control on study documents, program specifications, and deliverables developed by team members. • Monitor key performance indicators and metrics to identify opportunities for process improvement. • Prepare and update data management documentation, including DMPs, CCGs, and DVS, throughout the trial lifecycle. • Ensure compliance with industry regulations, guidelines, and procedures in all data management activities. • Collaborate with clinical operations, biostatistics, and programming teams to enhance operational efficiency. • Utilize analytics tools to identify risks and develop mitigation strategies for clinical trial data management. Clinical Data Manager Job Requirements • Bachelor’s degree in health sciences or a relevant scientific/technical discipline preferred. • Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry. • CCDM certification preferred, demonstrating advanced knowledge in clinical data management practices. • Proficiency in Microsoft Office applications, including MS Project and MS Excel. • Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies. • Experience with EDC systems, Cloud SaaS platforms, and data reporting tools such as Qlik and Spotfire preferred. • Exposure to CDISC guidelines and standards, as well as RBQM methodologies. • Familiarity with AI and ML technologies for anomaly detection and data quality enhancement.