Clinical Data Manager

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.