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Central Monitor II

2 weeks, 6 days ago
India
Junior
Data Analyst
Data Science and Analytics
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 60

Description

  • Lead development of Risk-Based Quality Management (RBQM) plans.
  • Conduct study risk assessments and develop mitigation strategies with functional team leads and project management.
  • Perform centralized statistical monitoring and remote centralized data review to detect anomalies, trends, and risks.
  • Support monthly RBQM meetings by reviewing study data, documenting findings, and tracking action plans.
  • Coordinate data cleaning activities to support study deliverables.
  • Ensure data quality and integrity through proactive monitoring and timely interventions.
  • Collaborate with clinical operations, data management, biostatistics, and other teams to support oversight and remediation.
  • Prepare reports and presentations on monitoring activities, findings, and recommendations.
  • Oversee operational study metrics such as data entry trends, SDV backlog, and site health trending.
  • Work independently on more complex studies and manage report review and issue escalation.

Requirements

  • Bachelor’s degree in a relevant field such as life sciences, statistics, data management, or clinical operations, or equivalent education/training/experience.
  • Minimum 2 years of experience in clinical monitoring, clinical trial management, or equivalent experience.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Strong understanding of RBQM principles and methodologies.
  • Highly effective oral and written communication skills.
  • Excellent organizational and time management skills.
  • Excellent written and spoken English, including strong grammar and scientific vocabulary skills.
  • Ability to work independently or in a team as needed.
  • Demonstrated ability to extract pertinent information from protocols, electronic study data systems, clinical systems, and dashboards to assess risk.
  • Proficiency in statistical analysis and data monitoring tools.
  • Detail-oriented with strong analytical and problem-solving skills.
  • CRO experience as a Central Monitor (preferred).

Interested in this position?

Apply directly on the company website

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