Central Monitor II

Precision Medicine Group, LLC.; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Precision for Medicine seeks a Central Monitor II to ensure data quality and integrity through centralized monitoring, RBQM planning, and proactive risk management. You will lead risk assessments, conduct centralized statistical monitoring, and coordinate data cleaning across studies, while mentoring junior staff as needed.

The role involves collaboration with clinical operations, data management, biostatistics, and other departments to support sponsors and study teams, with a focus on quality

Qualifications

• Bachelor’s degree in a life sciences, statistics, data management, clinical operations or equivalent.
• Minimum 2 years in clinical monitoring, clinical trial management or equivalent.
• Working knowledge of ICH GCP guidelines and the clinical development process.

Responsibilities

• Study Risk Assessment: conduct thorough risk assessments and develop mitigation strategies with functional leads.
• Centralized Statistical Monitoring: perform monitoring and data analysis to detect anomalies and risks.
• RBQM Meetings: support monthly RBQM meetings, review data, document findings and action plans.
• Data Quality Assurance: ensure data quality and integrity through proactive monitoring.
• Collaboration: work with operations, data management, biostatistics and other departments to support oversight and data cleaning.
• Reporting: prepare detailed reports and presentations on monitoring activities and recommendations.
• Operational Insights: monitor study metrics and site health, communicate issues to drive remediation

Skills

Communication skills

Organizational skills

Time management

English proficiency

Teamwork

Education

Bachelor’s Degree in a relevant field

Job description

Location: Bangalore, Karnataka, India
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7281

Position Summary

The Central Monitor II will play a key role in ensuring the quality and integrity 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 (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team

Essential functions of the job include but are not limited to:

• Study Risk Assessment:Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM
• 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 supporting review of study data, documenting findings, action plans and coordination of 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 & proactive remediation

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 managementor equivalent
• Working knowledge of ICH GCP guidelines and the clinical development process

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent 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