Central Monitor II

Precision Medicine Group; Bengaluru; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Precision Medicine Group is seeking a Central Monitor II to ensure data quality and integrity in clinical trials through centralized monitoring, RBQM planning, and risk management. The role involves leading risk assessments, statistical review, and proactive issue escalation while coordinating with cross-functional teams to support study deliverables.

Responsibilities include RBQM data reviews, monitoring trends, reporting findings to sponsors, and mentoring junior staff.

Qualifications

• Bachelor’s degree in life sciences, statistics, data management, or related field.
• Minimum 2 years in clinical monitoring or trial management.
• Working knowledge of ICH GCP guidelines.

Responsibilities

• Conduct study risk assessments and mitigation planning with functional leads.
• Perform centralized statistical monitoring and data analysis.
• Support RBQM meetings and document findings.
• Ensure data quality and integrity through proactive monitoring.
• Collaborate with clinical operations, data management, biostatistics.
• Prepare reports and recommendations for sponsors.

Skills

RBQM principles

Statistical analysis

Risk assessment

Report writing

Education

Bachelor's degree in life sciences or statistics

Job description

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
• 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 to leverage these data to assess risk
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills

Preferred:

• CRO experience as a Central Monitor

Skills:

• Statistical analysis and data monitoring
• Risk assessment and mitigation
• Report writing and presentation
• Collaboration and teamwork

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail] .

Candidates must be legally authorized to work in the country of employment without employer sponsorship.