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Central Monitor Ii

2+ years
Not Disclosed
10 June 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Central Monitor II


Location:

Bangalore, Karnataka, India


Job Type:

Regular Full-Time


Division:

Precision for Medicine – Clinical Solutions


Requisition Number:

5687


Position Summary:

The Central Monitor II plays a critical role in ensuring the quality and integrity of clinical trial data through centralized monitoring and risk-based quality management (RBQM). Responsibilities include leading risk assessments, performing statistical monitoring, supporting RBQM meetings, managing data quality assurance, collaborating across departments, and preparing reports for study sponsors. This role involves independent work on complex studies and mentoring junior team members.


Key Responsibilities:

  • Conduct comprehensive study risk assessments and develop mitigation strategies.

  • Perform centralized statistical monitoring and data review to detect anomalies and risks.

  • Support monthly RBQM meetings by documenting findings and coordinating data cleaning.

  • Ensure data quality and integrity through proactive monitoring.

  • Collaborate with clinical operations, data management, and biostatistics teams.

  • Prepare detailed reports and presentations on monitoring activities.

  • Oversee operational metrics such as data entry trends, site health, and issue escalation.


Qualifications:

Minimum Required:

  • Bachelor’s degree in Life Sciences, Statistics, Data Management, Clinical Operations, or equivalent.

  • Minimum 2 years’ experience in clinical monitoring or clinical trial management.

  • Working knowledge of ICH GCP guidelines and clinical development processes.

  • Strong communication, organizational, and time management skills.

  • Proficiency in statistical analysis and data monitoring tools.

  • Solid understanding of RBQM principles.

Preferred:

  • Experience as a Central Monitor in a CRO setting.


Skills:

  • Statistical analysis & data monitoring

  • Risk assessment & mitigation

  • Report writing & presentation

  • Team collaboration & mentorship