Central Monitor II

Project Farma (PF); Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Precision Medicine Group in Bengaluru is seeking a Central Monitor II to safeguard trial data integrity through centralized monitoring, RBQM planning, and proactive risk management.

You will lead risk assessments, perform centralized statistical monitoring, coordinate data cleaning, and prepare sponsor reports while mentoring junior staff. Strong communication and cross‑functional collaboration are essential for success.

Qualifications

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

Responsibilities

• Study Risk Assessment: conduct risk assessments and mitigation plans with functional leads.
• Centralized Statistical Monitoring: analyze study data to detect anomalies and risks.
• RBQM Meetings: support monthly RBQM meetings, document findings and action plans.
• Data Quality Assurance: ensure data quality and timely interventions.
• Collaboration: work with operations, data management, biostatistics and other teams.
• Reporting: prepare detailed monitoring reports and sponsor-facing presentations.
• Operational Insights: monitor study metrics and drive proactive remediation.

Skills

Statistical analysis

Data monitoring

Risk assessment

Report writing

Presentation skills

Collaboration

Education

Bachelor’s Degree in Life Sciences or related field

Job description

Job Description:

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:

Minimum Required:

• 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.