Clinical Data Manager

Position Title: Clinical Data Manager

Work Location: Maple Grove, MN 55311

Assignment Duration: 6-month contract with potential to extend highly likely

Work Schedule: 9:00am-5:00 PM-May potentially become a Hybrid role after 3-4 months training, but will be 100 % onsite to start with

Position Summary: The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.

Background & Context: As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

Key Responsibilities:

• Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
• Review of 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, as described in Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.
  
  Qualification & Experience:
• Education Level
  
  
  
  • Bachelor's degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent
  
  
  
  
• Experience/Background
  
  
  
  • Top Skills Needed:
    
    
    
    • Analytical and critical thinking skills along with related work experience,.
    • Data management/Analysis (not statistical analysis)with the relative previous past work experience.
    • Good Organizational Skills
    • Detail Oriented and Ability to multitask.
    
    
    
    
  • Experience Needed-
    
    
    
    • 3 years in clinical operations or healthcare related field.
    • Education and work experience in project management, life sciences and/or technical field.
    • Knowledge of data collection best practices for clinical trials; Knowledge of global clinical operations.
    • Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.
      
      
    
    
    
    
  
  
  
  
• Licenses and Certifications
  
  
  
  • None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.