Consulting Clinical Data Manager

Client Partnership and Consulting 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.

Clinical Data Management Responsibilities:

• 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. 

Data Analytics and Reporting Responsibilities:

• 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.

Regulatory Compliance and Quality Assurance Responsibilities:

• 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. 

Training and Support Responsibilities:

• 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.

Project Management Responsibilities:

• 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.

Innovation and Continuous Improvement Responsibilities:

• 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. 
• Share insights and best practices across the organization and with customers to promote continuous improvement.

Qualifications-- Education & Experience:

• 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.

Qualifications-- Technical Skills:

• 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). 
• Experience in presenting technical solutions to both technical and non-technical audiences.

Qualifications-- Soft Skills:

• Outstanding consulting and relationship management skills with the ability to build trust and credibility with customers.
• Excellent leadership and project management skills, with the ability to manage multiple complex projects simultaneously. 
• Strong presentation and communication skills, with the ability to articulate complex data concepts to diverse stakeholder groups. 
• A proactive problem-solver with a keen eye for detail and a commitment to data integrity. 
• Excellent writing skills including ability to write detailed reports for customers and the government. 
• Superior interpersonal skills with a proven ability to work effectively with customers, sponsors, external partners, and government partners, ensuring clear communication, successful project outcomes, and strong professional relationships. 
• Ability to influence and negotiate with stakeholders at all levels.