Remote Consulting Clinical Data Manager

Summary

Join our team as a seasoned Clinical Data Management expert and serve as a trusted advisor to our clients while leading and overseeing all aspects of data management for clinical trials.

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
• Demonstrated success in customer-facing roles working with pharma sponsors, biotechs, CROs and academic medical centers
• Track record of building and maintaining successful customer relationships
• Proficiency in database management systems (e.g., SQL, Oracle) and data visualization tools (e.g., Tableau, Power BI)
• Strong understanding of data governance, security, and regulatory compliance, particularly 21 CFR Part 11
• Advanced knowledge of clinical data standards (e.g., CDASH, CDISC)

Responsibilities

• Serve as a trusted advisor to clients, providing strategic guidance on data management strategies, best practices, and appropriate use of Vibrent’s products within those strategies and practices
• Build and maintain strong relationships with a range of organizations: sponsors, CROs, AMCs or other stakeholders through regular consultation and partnership
• Lead client discovery sessions to understand requirements and develop tailored data management solutions
• Present data management strategies, solutions, and insights to client stakeholders at all levels
• Provide thought leadership and strategic recommendations for improving clients' clinical data processes
• 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
• Partner with customers to 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
• Present analytical findings and recommendations to clients in a clear, actionable format
• 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 customized training programs for customer study teams and site personnel on data management systems, eConsent, IWRS, and compliance requirements
• Provide ongoing consultative support and troubleshooting for clinical database and data management issues
• Create and maintain customer-specific standard operating procedures and best practice guidelines
• Coordinate with cross-functional teams, including IT, biostatistics, clinical operations, and regulatory affairs, to ensure seamless execution of data management activities for customer projects
• Manage project timelines, deliverables, and resource allocation to ensure successful completion of data management tasks
• Maintain regular communication with customers regarding project status, risks, and mitigation strategies
• 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

Benefits

• Competitive compensation package that includes over-average 401k match
• Benefits you need to prioritize self and family care
• Support for your further education and career development