Clinical Data Manager

August 16

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Vibrent Health

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Description

• Design, implement, and manage data management plans for clinical trials, ensuring alignment with project timelines and regulatory requirements. • Develop, validate, and maintain clinical databases, including CDASH-compliant CRFs and IWRS systems. • Oversee eConsent system development, ensuring seamless integration with other clinical trial systems. • Lead data cleaning, verification, and reconciliation processes, ensuring data accuracy and consistency. • Develop and manage real-time operational reporting tools, including dashboards for subject accrual, protocol deviations, and site monitoring. • Utilize advanced data analytics to provide actionable insights to study teams and stakeholders. • Implement and maintain data visualization tools to enhance data accessibility and decision-making. • Ensure compliance with all relevant regulatory standards, including 21 CFR Part 11, GCP, HIPAA, GDRP and other global regulations. • Develop and implement comprehensive data quality assurance protocols, including audit preparation and risk management plans. • Lead the maintenance of the electronic Trial Master File (eTMF), ensuring all documentation is accurate, up-to-date, and audit-ready. • Develop and deliver training programs for study teams and site personnel on data management systems, eConsent, IWRS, and compliance requirements. • Provide ongoing support and troubleshooting for clinical database and data management issues. • Coordinate with cross-functional teams, including IT, biostatistics, clinical operations, and regulatory affairs, to ensure seamless execution of data management activities. • Manage project timelines, deliverables, and resource allocation to ensure successful completion of data management tasks. • Stay abreast of industry trends, emerging technologies, and best practices in clinical data management. • Drive innovation in data management processes, tools, and systems to enhance efficiency, accuracy, and regulatory compliance.

Requirements

• Bachelor’s in Data Science, Computer Science, Health Informatics, or a related field; Master’s degree strongly preferred. • Minimum of 10 years of experience in clinical data management, with a focus on clinical trials and regulatory compliance. • Proven experience with eConsent systems, EDC, data harmonization, IWRS, MedDRA, and WHODrug coding. • Experience performing data management activities with more than 50 clinical trials • Experience working with pharma sponsors, biotechs, CROs and academic medical centers.