Job Description

Job Title: Clinical Data Manager

6 month contract

On-site in Maple Grove, MN

Must be able to work on a W2

Job Summary:

The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems to support clinical research studies. This role oversees 3–5 clinical trials, leading activities from CRF design, data review, and monitoring to trial closure. The Clinical Data Manager serves as the main liaison for data review, ensuring alignment with customer requirements and providing analysis of study data by collaborating with Project Managers, Clinical Scientists, Statisticians, and other cross-functional teams.

Job Responsibilities:

• Participate in or lead the review of Clinical Research documents, including protocols, reports, and statistical analysis plans.
• Identify study-specific risks to study conduct and human subject safety; analyze risks and develop and implement mitigation strategies.
• Review study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact, and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities per the Central Monitoring Plan.
• Direct all data cleaning activities related to assigned studies.
• Collaborate with coordinators to oversee all related activities from CRF design to trial closure data activities.

Job Qualifications:

• Education: Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, or equivalent field.
• Experience: Minimum of 3 years in clinical operations or a healthcare-related field; background in project management, life sciences, or technical disciplines.
• Demonstrated experience with data management and analysis (excluding statistical analysis).
• Knowledge of data collection best practices for clinical trials and global clinical operations.
• Experience in a consultative role with subject matter expertise, influencing team decisions to achieve desired outcomes.
• Strong analytical and critical thinking skills; able to translate clinical trial requirements into technical specifications.
• Excellent organizational skills; detail-oriented with the ability to multitask.
• Proficient at identifying risks, developing mitigation and monitoring strategies, and making inferences based on limited information.
• Intermediate project management skills with the ability to manage complex dependencies and maintain collaborative relationships.
• Intermediate therapy-specific knowledge of anatomy, physiology, pathophysiology, therapy, and devices is preferred.
• Licenses/Certifications: None required; Certified Clinical Data Manager (CCDM) or equivalent certification is a plus.

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