Clinical Data Manager - Study Database Management

Clinical Data Manager – Study Database Management

Location: Maple Grove, MN (100% Onsite)
Job Type: Full-Time Contract | 6 Months (Strong Potential for Extension)
Schedule: Monday–Friday | 40 Hours per Week
Start Date: ASAP, Following Completion of Required Screenings
Industry: Medical Device / Clinical Research

Position Overview

Viltis is seeking an experienced Clinical Data Manager – Study Database Management professional to support a leading medical device organization in Maple Grove, Minnesota.

This position will play a critical role in the development, configuration, validation, and maintenance of clinical study databases, ensuring data quality, regulatory compliance, and alignment with clinical research requirements.

The ideal candidate will have hands-on experience configuring clinical study databases, programming edit checks, reviewing database specifications, and collaborating with cross-functional clinical research teams. This individual must demonstrate strong analytical skills, technical problem-solving abilities, and the confidence to lead discussions and influence decisions in a highly regulated environment.

This is an excellent opportunity for an experienced clinical data management professional to contribute to complex medical device clinical studies, with strong potential for contract extension.

Key Responsibilities

Clinical Database Development & Management

• Design, configure, develop, test, validate, and maintain clinical study databases using clinical data management systems (CDMS).
• Lead and participate in clinical database setup activities, including edit check programming and validation.
• Review database functional requirements, specifications, and edit check documentation to ensure accuracy and completeness.
• Ensure clinical database structures support downstream data analysis, reporting, and regulatory requirements.
• Follow established software development lifecycle (SDLC) processes for database development, testing, debugging, and documentation.

Clinical Study Support & Collaboration

• Collaborate with Clinical Data Management, Clinical Operations, Biostatistics, and other cross-functional stakeholders.
• Review clinical study protocols, Case Report Form (CRF) designs, clinical study reports, and statistical analysis plans.
• Provide technical input and recommendations to improve database functionality, data collection processes, and data quality.
• Lead technical discussions, facilitate decision-making, and influence stakeholders toward effective solutions.
• Support multiple clinical study activities while maintaining project timelines and quality standards.

Data Quality, Validation & Compliance

• Ensure clinical databases comply with established organizational standards, conventions, and regulatory requirements.
• Perform database validation, troubleshooting, and quality control activities.
• Identify, investigate, and resolve clinical database errors, system issues, and data management challenges.
• Escalate critical issues appropriately to minimize downtime and maintain study continuity.
• Support compliance with FDA 21 CFR Part 11, Good Clinical Practice (GCP), and applicable clinical data management guidelines.

Required Qualifications

• Minimum 5 years of professional experience within the medical device, pharmaceutical, or biopharmaceutical industry.
• Minimum 2 years of hands-on experience using a clinical data management system to configure and set up clinical study databases, including edit check programming.
• Demonstrated experience in clinical database development, configuration, testing, and validation.
• Strong understanding of clinical data management processes, database specifications, and data quality requirements.
• Excellent analytical, critical thinking, and troubleshooting skills.
• Strong written and verbal communication skills with the ability to collaborate effectively across technical and clinical teams.
• Demonstrated ability to lead discussions, influence team decisions, and manage complex activities in regulated clinical research environments.
• Ability to manage multiple priorities independently while maintaining attention to detail and quality.
• Ability to work 100% onsite in Maple Grove, Minnesota.

Preferred Qualifications

• Experience configuring clinical study databases using one or more of the following systems:
• • Oracle Clinical
  • Oracle Clinical InForm
  • Oracle Life Sciences Cloud
  • Other comparable clinical data management systems
• Working knowledge of FDA 21 CFR Part 11 requirements.
• Familiarity with Good Clinical Practice (GCP) standards and clinical data-handling guidelines.
• Experience supporting regulated medical device clinical studies.
• Experience reviewing CRFs, clinical study protocols, and statistical analysis plans.
• Experience collaborating with multidisciplinary teams on complex clinical research initiatives.

Key Skills for Success

• Clinical Study Database Development & Configuration
• Clinical Data Management Systems (CDMS)
• Edit Check Programming & Validation
• Clinical Database Specifications
• CRF Design & Protocol Review
• Clinical Data Quality & Regulatory Compliance
• Analytical Thinking & Technical Troubleshooting
• Cross-Functional Collaboration
• Stakeholder Communication & Decision-Making
• Clinical Study Database Lifecycle Management

Position Details

Work Location: Maple Grove, MN 55311
Work Arrangement: 100% Onsite
Contract Duration: Initial 6-month assignment with strong potential for extension
Hours: 40 hours per week, Monday–Friday
Start Date: As soon as required pre-employment screenings are completed
Travel: None anticipated

Why Join Viltis?

At Viltis, we connect talented professionals with meaningful opportunities across the medical device, biotechnology, pharmaceutical, and healthcare industries.

As a Clinical Data Manager, you will have the opportunity to support important clinical research initiatives, collaborate with experienced industry professionals, and contribute to the development of high-quality clinical data systems supporting innovative medical technologies.

Apply Today

If you are an experienced Clinical Data Manager with hands-on clinical study database configuration and edit check programming experience, we encourage you to apply.

Please submit your most recent resume highlighting your clinical data management systems experience, database development responsibilities, and relevant medical device or pharmaceutical industry background.

Viltis is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.