Senior Clinical Monitoring Specialist

6 days ago

Alwar, Rajasthan, India beBeeClinical Full time ₹ 75,00,000 - ₹ 1,25,00,000
Job Description:

The Central Monitoring professional will play a pivotal role in ensuring the integrity and quality of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

This position involves leading the development of Risk-Based Quality Management plans, conducting study risk assessments, identifying study key risk indicators, performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

Additionally, this role requires working independently and managing report review and issue escalation for complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and support the development of processes, procedures, and other documentation to ensure a high-performing team.

  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and project managers.
  • Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • RBQM Meetings: Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  • Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members to drive towards resolution and proactive remediation.
Required Skills and Qualifications:
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
Benefits:
  • Excellent oral and written communication skills with the ability to communicate effectively with project team members.
  • Strong organizational and time management skills.
  • Excellent written and spoken English, including strong grammar and scientific vocabulary skills.
  • Ability to work in a team or independently as required.
  • Strong understanding of RBQM principles and methodologies.
  • Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and leverage these data to assess risk.
  • Proficiency in statistical analysis and data monitoring tools.
  • Detail-oriented with strong analytical and problem-solving skills.
Others:
  • CRO experience as a Central Monitor.

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