Clinical Data Manager

Cambridge, Massachusetts

Employer: System One Holdings, LLC
Industry: 
Salary: Competitive
Job type: Full-Time
Title: Data Operations Manager

Type: Contract

Work Location: on site in Cambridge, MA

Exciting contract Data Operations Manager opportunity available with a world leader in clinical research. If you are interested, apply today!

QUALIFICATIONS:
  • BA/BS degree in Health Informatics, Computer Science, Information Systems, or similar field
  • Digital vendor management and operational monitoring of digitally derived data
  • Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements
  • At least three years of technical experience, including:
    • Python
    • Unix/Linux environments
    • AWS or other cloud-based development
    • Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave
    • Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
  • Strong interpersonal and collaboration skills
  • Demonstrate the ability to build consensus and be agile to changing circumstances and priorities

PREFERRED QUALIFICATIONS
  • Masters degree in health informatics, computer science, information systems or a similar scientific field
  • Clinical trial experience involving, operationalizing, deploying and monitoring digital health technologies and imaging associated data
  • Experience processing large data sets (including from digital health technologies) in a distributed computing environment
  • Experience with SQL or NoSQL-based technologies
  • Comprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing tools

MIN REQUIREMENTS
  • A minimum of a BA/BS in Health Informatics, Computer Science, Information Systems, or other similar scientific field
  • At least three years of experience, including:
    • Research/clinical trial experience
    • Electronic data captures (EDC) solutions, e.g., REDCap, Oracle Clinical
    • Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
    • Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements
    • GCP

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical calculations and ability to work with large complex data sets.
Created: 2024-09-07
Reference: 326060
Country: United States
State: Massachusetts
City: Cambridge
ZIP: 02142

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