Clinical Data Manager: Data Integrity & Compliance

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

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.