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Central Monitor II

2 hours, 6 minutes ago
India
Full-time
Junior
Operations Analyst
Data Science and Analytics
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 52

Description

  • Lead the development of Risk-Based Quality Management (RBQM) plans for clinical studies.
  • Conduct study risk assessments and develop mitigation strategies in consultation with functional team leads and project managers.
  • Perform centralized statistical monitoring and data analysis to identify anomalies, trends, and potential risks.
  • Support monthly RBQM meetings by reviewing study data, documenting findings and action plans, and coordinating data cleaning activities.
  • Ensure high standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaborate with clinical operations, data management, biostatistics, and other departments to support study oversight and remediation.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Oversee operational study metrics such as data entry trends, SDV backlog, and site health trending, and escalate issues to drive resolution.
  • Manage report review and issue escalation for more complex studies and portfolios of work.
  • Mentor junior colleagues and support the development of team processes, procedures, and documentation.

Requirements

  • Bachelor’s degree in a relevant field such as life sciences, statistics, data management, or clinical operations, or an equivalent combination of education, training, and experience.
  • Minimum 2 years of experience in clinical monitoring, clinical trial management, or a similar role.
  • 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 as part of a team as required.
  • Proficiency in statistical analysis and data monitoring tools.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Ability to extract pertinent information from protocols, electronic study data systems, clinical systems, and dashboards to assess risk.
  • CRO experience as a Central Monitor is preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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