Clinical data manager

Responsibilities:

• Lead the design, development, and implementation of data collection tools and databases aligned with study protocols and CDISC standards.
• Supervise data management activities across multiple clinical trials, ensuring timely and accurate data entry, validation, and reconciliation.
• Review source documents and case report forms (CRFs) meticulously for completeness, consistency, and compliance with regulatory requirements such as FDA regulations and ICH GCP guidelines.
• Collaborate closely with clinical research teams to monitor patient data collection processes, including vital signs, blood sampling, and patient monitoring activities.
• Oversee the review of laboratory reports, EMR systems integration, and other clinical documentation to maintain high-quality data standards.
• Ensure adherence to HIPAA regulations and maintain confidentiality of patient information throughout all data management procedures.
• Utilize statistical software tools for data analysis support and prepare datasets for statistical review and reporting.
• Manage documentation workflows, including audit trails, protocol amendments, and regulatory submissions to ensure compliance with FDA regulations and ICH GCP standards.
• Provide supervision and mentorship to junior staff or contract personnel involved in data management activities.
• Support clinical laboratory activities by understanding blood sampling procedures, phlebotomy protocols, and analysis skills necessary for accurate data interpretation.

Skills:

• Proven supervising experience in clinical trial environments with a strong understanding of clinical trials management processes.
• Extensive knowledge of medical terminology, clinical research methodologies, and regulatory frameworks such as FDA regulations and ICH GCP guidelines.
• Proficiency in data collection methods using EMR systems, electronic data capture (EDC) platforms, and CDISC standards for data formatting.
• Strong documentation review skills with attention to detail in source documents, case report forms (CRFs), lab reports, and other clinical records.
• Experience monitoring patient safety parameters including vital signs and blood sampling procedures within clinical trials.
• Familiarity with statistical software packages used in clinical research for data analysis purposes.
• Knowledge of clinical laboratory procedures related to blood sampling, phlebotomy techniques, and blood sample handling.
• Ability to manage compliance requirements related to HIPAA privacy rules while handling sensitive health information.
• Excellent analysis skills for identifying discrepancies or inconsistencies in complex datasets; capable of troubleshooting issues proactively.
• Understanding of research protocols involving clinical development phases from early-phase studies through late-stage trials.