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Clinical Data Manager
Spectraforce
Maple Grove, Minnesota

2 days ago

Job Description

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.
 

Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $42.00/hr.

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