Precision Medicine Group is hiring for the position of Central Monitor II in Bangalore, Karnataka, India. The role focuses on centralized clinical trial monitoring, statistical data review, risk-based quality management (RBQM), and proactive identification of clinical study risks.
Candidates with a relevant bachelor’s degree, at least two years of experience in clinical monitoring, clinical trial management, or an equivalent area, and knowledge of ICH Good Clinical Practice (GCP) guidelines can apply.
The position involves working with clinical operations, data management, biostatistics, and other functional teams to maintain clinical trial data quality and support risk-based oversight.
Job Details
| Particulars | Details |
|---|---|
| Company | Precision Medicine Group |
| Job Title | Central Monitor II |
| Location | Bangalore, Karnataka, India |
| Work Model | Hybrid – 2 days weekly from the Bangalore (Mahadevapura) office |
| Experience | Minimum 2 years |
| Qualification | Bachelor’s degree in a relevant field or equivalent education, training, and experience |
| Industry | Clinical Research / Clinical Operations |
| Employment Eligibility | Must be legally authorized to work in the country of employment without employer sponsorship |
Position: Central Monitor II
The Central Monitor II independently manages centralized monitoring activities for clinical studies, including study risk assessments, statistical data analysis, Key Risk Indicator (KRI) monitoring, data quality reviews, and issue escalation.
The role also supports monthly RBQM meetings, prepares monitoring reports, tracks operational study metrics, and may mentor junior colleagues or contribute to the development of team processes and procedures.
Key Responsibilities
- Study Risk Assessment: Identify potential clinical study risks and develop mitigation strategies in consultation with functional team leads and project managers.
- Centralized Statistical Monitoring: Analyze clinical trial data to identify anomalies, trends, and potential risks.
- Risk-Based Quality Management: Support RBQM plans, study risk assessments, KRI identification, and monthly RBQM meetings.
- Data Quality Assurance: Maintain clinical trial data quality and integrity through proactive monitoring and timely interventions.
- Cross-Functional Collaboration: Work with clinical operations, data management, biostatistics, and other teams to support study oversight and data cleaning.
- Reporting and Documentation: Prepare reports and presentations covering monitoring activities, findings, and recommendations for sponsors and study teams.
- Operational Metrics Monitoring: Review data entry trends, source data verification (SDV) backlogs, and site health trends to identify issues and support resolution.
- Issue Escalation: Review reports and escalate issues for complex studies or portfolios of work.
- Team Support: Mentor junior colleagues when required and contribute to process, procedure, and documentation development.
Eligibility and Qualifications
Candidates applying for the Central Monitor II position should meet the following requirements:
- Bachelor’s degree in Life Sciences, Statistics, Data Management, Clinical Operations, or a relevant field.
- Equivalent combinations of education, training, and experience may also be considered.
- Minimum two years of experience in clinical monitoring, clinical trial management, or an equivalent area.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Strong understanding of risk-based quality management (RBQM) principles and methodologies.
- Ability to extract and interpret relevant information from clinical protocols, electronic study data systems, clinical systems, and dashboards.
- Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Preferred qualification: CRO experience as a Central Monitor.
Required Skills
- Statistical analysis and clinical data monitoring.
- Clinical study risk assessment and mitigation.
- Key Risk Indicator (KRI) monitoring.
- RBQM planning and implementation.
- Clinical data quality review and analysis.
- Report writing and presentation.
- Strong analytical and problem-solving abilities.
- Excellent written and spoken English, including grammar and scientific vocabulary.
- Effective oral and written communication.
- Strong organizational and time management skills.
- Ability to work independently and collaboratively.
