We are seeking a seasoned Clinical Data Manager to lead and oversee all aspects of data management for clinical trials. This role requires a deep understanding of clinical trial processes, eConsent systems, clinical database development, and regulatory compliance. The ideal candidate will excel in managing complex data systems, ensuring data integrity, and providing critical insights 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.
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:
- 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.
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 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.
Project Management Responsibilities:
- 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.
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.
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.
- Experience working with pharma sponsors, biotechs, CROs and academic medical centers.
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).
Qualifications - Soft Skills:
- Excellent leadership and project management skills, with the ability to manage multiple complex projects simultaneously.
- Strong communication skills, with the ability to articulate complex data concepts to non-technical stakeholders.
- 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.
- Excellent 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.
When you work at Vibrent, you are surrounded by a diverse group of people who share a passion for achieving excellence and making a lasting impact. Passion, excellence and impact should be rewarded, and we do that-- offering a competitive compensation package that includes over-average 401k match, the benefits you need to prioritize self and family care, and support for your further education and career development.
Vibrent is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, or veteran status.
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