Short-term RBQM and Central Monitoring specialist role requiring 3–5 years of experience to support technology strategy, centralized monitoring, risk assessment, analytics, and cross-functional collaboration for clinical trial quality improvement.
Job Type: Hybrid
Location: Pune/Bangalore
Experience: 3- 5+ Years
Contract Length: 3-4 Months
| Key Responsibilities |
| Technology Strategy & System Development • Provide feature requirements for IQRM system development from a Central Statistical Monitoring (CSM) perspective. • Evaluate the eCS platform and deliver structured feedback for optimization. • Contribute to the development of the CM agent feature for the RBQM 360 asset. • Support system configuration, testing, validation, and deployment of eCS and RBQM 360 platforms. |
| RBQM Framework & Process • Support implementation of RBQM frameworks to identify, assess, and mitigate clinical trial risks. • Identify critical data points impacting trial quality, patient safety, and compliance. • Assist in developing risk management plans and centralized monitoring approaches. |
| Requirements & Translation • Gather requirements from Clinical Ops, Data Management, QA, and Tech teams. • Translate clinical/regulatory needs into technology system specifications. • Prepare Business Requirement Documents (BRD), functional specs, and workflow diagrams. |
| Solution Design & Analytics • Recommend and design tech solutions supporting RBQM processes. • Develop tools for centralized monitoring, risk indicators, and data visualization dashboards. • Analyze trial data to identify risk indicators, anomalies, and quality issues. • Support development/monitoring of Key Risk Indicators (KRIs) and KPIs with analytics teams. |
| Monitoring & Reporting • Review centralized monitoring dashboards to track risks and operational metrics. • Analyze trends (e.g., protocol deviations, site performance, data delays). • Investigate data anomalies flagged by dashboards and determine root causes. • Coordinate with site monitors and stakeholders to resolve issues. • Build dashboards and visual reports to communicate risks and quality metrics. |
| Collaboration & Communication • Collaborate with Advisors, Business Consultants, and Technology teams daily. • Facilitate stakeholder meetings to review trial risks and data quality. • Present insights and risk assessments to project teams, leadership, and clients. • Provide recommendations to improve monitoring strategies and trial processes. |
| Qualifications |
| Experience 3-5+ years in clinical research, clinical data management, or related field (Pharma/Biotech/CRO). |
| RBQM Knowledge Deep understanding of RBQM principles, methodologies, and regulatory expectations (ICH E6(R2), FDA guidance). |
| Technical Acumen Experience with clinical systems (EDC, eTMF, CTMS). Ability to gather requirements for tech platforms. Familiarity with data visualization tools (Spotfire, Qlik, PowerBI) is a plus. |
| Analytical Skills Strong ability to interpret complex clinical trial data and identify meaningful patterns and risks |
| Documentation Proven experience creating clear BRDs, functional specifications, and risk plans. |
| Collaboration Team player capable of working effectively in a fast-paced, cross-functional environment. |