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Central Monitor II

23 hours, 33 minutes ago
India
Full-time
Junior
Operations 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 11

Description

  • Lead development and implementation of RBQM plans for assigned studies or portfolios.
  • Conduct study risk assessments to identify potential issues and develop mitigation strategies in consultation with functional leads and project managers.
  • Identify study key risk indicators (KRIs) in collaboration with functional leads and monitor them throughout the study.
  • Perform ongoing centralized statistical monitoring and data analysis to detect anomalies, trends, and potential risks.
  • Conduct remote centralized data review and coordinate data cleaning activities to support study deliverables.
  • Facilitate and support monthly RBQM meetings by documenting findings, action plans, and follow-up items.
  • Manage report review and escalate issues for more complex studies or portfolios as needed.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Oversee operational study metrics (data entry trends, SDV backlog, site health trending) and proactively communicate issues to study team members to drive resolution.
  • Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and study management.

Requirements

  • Bachelor’s degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent combination of education/experience.
  • Minimum 2 years’ experience in clinical monitoring or clinical trial management (or equivalent).
  • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Strong understanding of RBQM principles and methodologies.
  • Proficiency in statistical analysis and data monitoring tools.
  • Demonstrated ability to extract and leverage information from protocols, electronic study data systems, clinical systems, and dashboards to assess risk.
  • Highly effective oral and written communication skills in English, including scientific and technical vocabulary.
  • Excellent organizational, time-management, analytical, and problem-solving skills; detail-oriented.
  • Ability to work independently and collaboratively within cross-functional teams.
  • Preferred: CRO experience as a Central Monitor.

Interested in this position?

Apply directly on the company website

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