Job Description: We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will drive the success of our clinical development programs by coordinating data activities across multiple studies, supporting research teams, and ensuring adherence to industry best practices. This position offers an exciting opportunity to contribute to innovative medical research that impacts patient care worldwide.
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.
