Manager, Central Monitoring, Data Analysis

ManagerManagerFull TimeRemoteTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

62 days ago

Salary

Not specified

Bachelor Degree4 yrs expEnglishGoogle Cloud PlatformPythonSQL

Job Description

• Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies • Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system • Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system • Provide operational expertise, training, and guidance as a point of escalation • Conduct central monitoring reviews in support of study central monitor • Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials

Job Requirements

  • At least 4 years of relevant biotechnology/pharmaceutical industry experience
  • Central Monitoring, site monitoring or data management experience a plus
  • Minimum 2 years with direct RBQM systems experience
  • Technical expertise in database design, system configuration, and report development
  • Proficiency in programming languages such as Python, R, SQL, or SAS
  • Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
  • Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures
  • Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting

Benefits

  • Health insurance
  • Paid time off
  • Flexible work arrangements
  • Professional development

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