Job Summary
We are seeking a dynamic, independent, and experienced Central Monitor / Senior Central Monitor to oversee centralized clinical data review across therapeutic areas. The role focuses on proactive analysis of clinical data trends to ensure data quality, subject safety, and protocol compliance using risk-based monitoring.
The candidate will review and integrate data from multiple sources (EDC, labs, safety, vendors) and deliver timely, accurate insights to stakeholders.
Working closely with cross-functional teams, the role will identify risks, detect anomalies, and support issue resolution, driving quality improvements in line with RBQM and regulatory standards.
Roles & Responsibilities
Key Responsibilities
- Perform ongoing centralized (remote) monitoring of clinical trial data using multiple data sources (e.g., EDC, subject visits, central labs, vendors) to ensure data integrity, consistency, and subject safety. Identify data trends, anomalies, entry patterns, and risk signals related to quality, safety, efficacy, and site performance.
- Enable early identification of risks and issues during study conduct, generate risk alerts, and ensure timely escalation to stakeholders (Lead CM, Project Lead, Clinical Operations Lead, CRAs).
- Support on-site monitors (CRAs) by providing actionable insights on subject/site-specific risks and pending actions to enhance the effectiveness and focus of monitoring visits.
- Document all central monitoring activities, including risk identification, escalation, tracking, and resolution, ensuring traceability and inspection readiness.
- Collaborate with cross-functional teams (Clinical Operations, Data Management, Safety, Medical, Vendors) to manage subject, site, and study-level issues.
- Contribute to the development and maintenance of Key Risk Indicators (KRIs) and ensure alignment with study-specific and standardized risk frameworks.
- Perform advanced analytical reviews to focus on critical data impacting subject safety and study outcomes, including root cause analysis and systematic issue resolution.
- Liaise with external vendors and investigational sites to support timely resolution of data and operational queries.
- Identify protocol deviations, process gaps, and compliance risks, escalate appropriately, and support CAPA development, implementation, and effectiveness checks.
- Participate in study team meetings, risk review meetings, and cross-functional discussions as required.
- Support audits, inspections, and quality control activities, ensuring readiness and adherence to regulatory expectations.
- Perform periodic review of study documentation and TMF to ensure completeness, accuracy, and continuous inspection readiness.
Educational qualification: Master's degree in Pharmacy, Life Sciences, Biology, Biotechnology, or Biochemistry from a recognized institution Diploma/Certification in Clinical Research is an added advantage.
Skills & Attributes
Technical Skills
- Strong hands-onxperience with EDC systems (e.g., Oracle, Medidata Rave) for data review and query tracking
- Proficiency in central monitoring / RBQM tools (e.g., dashboards, KRI/QTL tracking, statistical monitoring platforms)
- Ability to perform data analytics and trend analysis using tools such as Excel (advanced), Power BI, Spotfire, or similar visualization platforms
- Expertise in risk indicators (KRI), Quality Tolerance Limits (QTLs), and signal detection
- Knowledge of data reconciliation processes (lab, SAE, vendor data)
- Understanding of protocol review, CRF design linkage, and edit checks
- Familiarity with CTMS, eTMF systems, and inspection readiness requirements
- Basic understanding of statistical concepts used in central monitoring (outliers, distributions, trends)
Preferred Qualifications & Experience
- 6-8 years of clinical research experience, including CRA (on-site monitoring) and Central Monitoring experience
- Strong understanding of RBQM principles, ICH E6(R2/R3), and GCP guidelines
- Experience in multi-source data review and risk-based monitoring strategies
- Strong analytical thinking, risk assessment, and root cause analysis skills
- Excellent communication and cross-functional collaboration abilities
ꂾhavioural/ Core Attributes
- Proactive and risk-focused mindset
- Attention to detail with quality-driven approach
- Ability to prioritize and manage multiple studies/tasks
- Strong stakeholder management and influencing skills
