Onsite Clinical Data Manager - Regulated Studies

Viltis; Maple Grove (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Viltis is seeking an experienced Associate Clinical Data Manager to support clinical study data management for a leading life sciences organization in Maple Grove, Minnesota. The role emphasizes data quality, regulatory compliance, and collaboration with cross-functional teams.

The ideal candidate will bring strong clinical data management experience, analytical and critical-thinking skills, and the ability to lead discussions on complex, regulated studies. Onsite work in Maple Grove is required.

Qualifications

• Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, Life Sciences or related technical discipline.
• 5+ years of experience in clinical operations, clinical data management, healthcare, or related field.
• Hands-on experience with clinical data management activities.
• Experience supporting regulated clinical studies.
• Knowledge of Good Clinical Practice (GCP) and global regulations.

Responsibilities

• Lead cross-functional teams during protocol development to identify data critical to study results and patient protection.
• Evaluate clinical study risks through protocol and study plan reviews.
• Collaborate with teams to validate risk findings and implement controls.
• Develop and revise CRFs, edit checks, data listings, and database setup.
• Identify and mitigate residual risks to critical study data and coordinate mitigation strategies.
• Develop data-cleaning and quality-management activities based on identified risks.
• Support site instructions and monitoring strategies; lead the Clinical Project Team in CRF development.
• Partner with the Study Database Manager throughout database development and release.
• Identify, program, and test edit checks for data discrepancies.
• Monitor accumulated subject data and perform root cause analyses of discrepancies.

Skills

Analytical thinking

Critical thinking

Communication

Collaboration

Leadership

Project management

Education

Bachelor’s degree in Biology Health Sciences Mathematics Computer Science Life Sciences

CCDM certification

Tools

EDC systems

Job description

Viltis is seeking an experienced Associate Clinical Data Manager to support clinical study data management for a leading life sciences organization in Maple Grove, Minnesota. The role emphasizes data quality, regulatory compliance, and collaboration with cross-functional teams.

The ideal candidate will bring strong clinical data management experience, analytical and critical-thinking skills, and the ability to lead discussions on complex, regulated studies. Onsite work in Maple Grove is required.