We are seeking a seasoned Clinical Data Management expert to serve as a trusted advisor to our clients while leading and overseeing all aspects of data management for clinical trials. This consultative role requires deep expertise in clinical trial processes, eConsent systems, clinical database development, and regulatory compliance, combined with strong client relationship management skills. The ideal candidate will excel in managing complex data systems, ensuring data integrity, and providing strategic guidance and critical insights to clients through advanced data analytics.
Vibrent Health is a remote-first organization, and this is a remote position. You will be equipped to work remotely on a team that is fully remote. Candidates in the Fairfax, VA area may utilize office space there and attend meetings face to face. Nationwide candidates must be prepared to attend daily meetings based on EST.
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.
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