Clinical Data Manager

Viltis; Maple Grove (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Viltis is seeking a Clinical Data Manager to oversee design, configuration, validation, and maintenance of clinical study databases, ensuring data integrity and regulatory compliance throughout the trial lifecycle.

You will collaborate with cross-functional teams including clinical operations, biostatistics, and quality assurance to develop study data management strategies, write edit checks, and support regulatory submissions.

Qualifications

• Minimum of 5 years in clinical data management or related field.
• Hands-on experience setting up study databases and edit checks.
• Knowledge of FDA 21 CFR Part 11 and GCP.
• Strong communication and multi-team collaboration.

Responsibilities

• Design, configure, develop, test, validate, and maintain clinical study databases.
• Review study protocols, CRFs, and analysis plans to ensure design meets requirements.
• Develop and maintain edit checks and data validation rules.
• Ensure data quality, compliance, and timely issue resolution.
• Collaborate with cross-functional teams to support study execution.

Skills

Analytical thinking

Clinical DB design

Data validation

Edit checks

Regulatory compliance

Cross-functional collaboration

Technical leadership

Root-cause analysis

Prioritization

Tools

Oracle Clinical

Oracle Life Sciences Cloud

Other CDL platforms

Job description

About Viltis Viltis is committed to supporting high-quality clinical research through reliable data management, scientific rigor, and a commitment to regulatory compliance. We value analytical thinking, collaboration, and innovative problem-solving to ensure clinical data is accurate, consistent, secure, and ready for analysis.

About the Role

Clinical Data Manager Company: Viltis Department: Clinical Operations / Data Management Work Arrangement: On-site or as determined by business needs Position Overview Viltis is seeking an experienced Clinical Data Manager to oversee the design, development, configuration, validation, and maintenance of clinical study databases. This role is responsible for ensuring the integrity, quality, and consistency of clinical trial data while maintaining compliance with applicable regulatory requirements, company procedures, and industry standards. The ideal candidate combines strong analytical and critical-thinking skills with hands-on experience in clinical data management systems, database configuration, and edit check programming. The candidate will collaborate with cross-functional teams, contribute to study design and data management strategies, resolve complex technical issues, and help drive informed decisions throughout the clinical study lifecycle.

Responsibilities

• Clinical Database Development: Design, configure, develop, test, validate, and maintain clinical study databases using appropriate clinical data management systems.
• Study Protocol and CRF Review: Review clinical study protocols, Case Report Forms (CRFs), clinical research reports, and statistical analysis plans to ensure database designs meet study requirements.
• Database Specifications: Review and contribute to database functional requirements, data structures, edit check specifications, and study-specific configuration documentation.
• Edit Check Programming: Develop, configure, test, and maintain edit checks and data validation rules to identify inconsistencies, missing information, and potential data quality issues.
• Data Quality and Compliance: Ensure clinical databases and associated deliverables meet quality standards, established procedures, applicable regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, statistical programming, quality assurance, and other stakeholders to support study execution and data integrity.
• Issue Resolution: Identify, troubleshoot, and resolve database and clinical data management system issues, escalating critical errors and service disruptions when necessary.
• Process Improvement: Identify opportunities to improve database design, data management workflows, validation processes, and operational efficiency.
• Documentation and Standards: Maintain accurate technical documentation and ensure adherence to company standards, software development lifecycle procedures, and data management best practices.
• Decision-Making and Leadership: Lead technical discussions, present recommendations, influence cross-functional decisions, and drive issues toward timely and effective resolution.
• Downstream Data Readiness: Ensure database structures, conventions, and data outputs support reliable downstream reporting, statistical analysis, and regulatory submissions.

Qualifications

• Minimum of 5 years of experience in clinical data management or a related role within the medical device, pharmaceutical, or biotechnology industry.
• At least 2 years of hands-on experience setting up clinical study databases in a clinical data management system, including edit check programming.
• Demonstrated understanding of clinical study database design, data validation, data quality control, and clinical data workflows.
• Experience reviewing clinical protocols, CRFs, database specifications, and study-related documentation.
• Knowledge of applicable regulatory requirements, including FDA 21 CFR Part 11 and Good Clinical Practice (GCP).
• Strong analytical, critical-thinking, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams.
• Demonstrated ability to manage multiple priorities, lead discussions, and influence decisions toward practical, quality-focused outcomes.
• Ability to work independently, exercise sound judgment, and deliver high-quality work in a deadline-driven environment.

Required Skills

• Analytical and critical thinking
• Clinical database design and configuration
• Clinical data validation and edit check programming
• Regulatory compliance and quality management
• Cross-functional communication and collaboration
• Technical leadership and decision-making
• Issue escalation and root-cause analysis
• Organization, prioritization, and independent problem-solving

Preferred Skills

• Experience with Oracle Clinical, Oracle Clinical Inform, Oracle Life Sciences Cloud, or other clinical data management platforms.
• Experience configuring study-specific databases and developing complex edit checks.
• Familiarity with clinical data standards, database validation practices, and regulated software development lifecycle processes.
• Experience supporting clinical studies in medical devices, pharmaceuticals, or biotechnology.
• Understanding of data structures and their application to statistical programming, clinical reporting, and regulatory submissions.
• Experience identifying process improvements and contributing to standardized database development practices.

Pay range and compensation package

Not specified.

Equal Opportunity Statement

Not specified.

What Success Looks Like

The successful candidate will deliver reliable, well-documented, and compliant clinical study databases; proactively identify and resolve data quality issues; collaborate effectively with cross-functional stakeholders; and help ensure clinical data is accurate, consistent, and ready for analysis and reporting. At Viltis, this role will contribute to the quality and efficiency of clinical research by combining technical expertise, regulatory awareness, and a collaborative approach to problem-solving.