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Clinical Trails Monitor II

Personal Genome Diagnostics - Bengaluru, Karnataka, India - In-office

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Labcorp, a global leader in laboratory services, is seeking a Clinical Trials Monitor II to join the Smart Supply team in Bengaluru. This role is responsible for developing and managing study-specific strategies to ensure clinical trial kits are available when and where needed while minimizing unnecessary inventory and waste. Key Responsibilities: Study Feasibility & Protocol Analysis: Review clinical trial protocols, visit schedules, enrollment assumptions, and study documentation to determine how Labcorp Smart Supply should be deployed. Identify study characteristics affecting kit supply such as enrollment patterns, visit schedules, treatment groups, and protocol amendments. Client Consultation & Operational Leadership: Lead discussions with clients and study teams on supply strategy, start-up quantities, and resupply approaches. Translate complex clinical and operational information into clear recommendations. Challenge requests that could increase supply risk or waste, and recommend practical alternatives. Start-Up & Resupply Strategy Design: Develop study-specific start-up kit strategies based on expected enrollment, site activation plans, and study design. Design ongoing resupply strategies accounting for patient demand, expiration, shipping lead time, and study risk. Tailor approaches by country, site, patient group, or kit type as needed. System Configuration & Quality Control: Configure and maintain Smart Supply services in internal systems. Perform detailed quality checks and peer reviews of supply strategies before activation. Investigate and correct errors and supply risks. Active Study Monitoring & Optimization: Monitor study activity including enrollment, site activity, kit inventory, orders, and key milestones. Analyze trends to identify supply risks, configuration gaps, and opportunities to reduce waste. Adjust strategies as study conditions change. Exception & Issue Management: Investigate system exceptions, failed orders, and data issues. Determine and coordinate corrective actions including system updates, order intervention, or client communication. Performance Analysis & Continuous Improvement: Evaluate kit utilization, waste, ordering activity, and service performance using dashboards and trackers. Use operational experience to improve service design and working practices. Training & Cross-Functional Coordination: Provide study-specific training to clients and internal partners. Create and maintain study documentation, configuration records, and risk logs. Coordinate across global teams and time zones. Work Schedule: Rotational shift (AM: 05:30 AM – 02:30 PM or PM: 02:00 PM – 11:00 PM) Requirements: Minimum Qualifications: - Bachelor's degree in life sciences, clinical research, healthcare, pharmacy, nursing, business, supply chain, or related field (equivalent relevant experience may be considered) - Minimum 3 years of relevant experience in clinical trial operations, central laboratory operations, global monitoring, study management, clinical supply, or related operational role Preferred Qualifications: - Experience in clinical trial kit supply, central laboratory services, investigator-site operations, patient recruitment/enrollment workflows, or study-specific supply forecasting - Working knowledge of how therapeutic area, patient pathway, study phase, and site operating model affect recruitment, visit execution, and kit demand - Experience with rule-based operational services, workflow tools, or clinical systems - Experience facilitating client meetings, delivering training, completing quality reviews, and managing operational risk in a regulated environment Key Competencies: - Advanced critical thinking and ability to connect study design, patient flow, site activity, enrollment, logistics, and operational impact - Constructive challenge and influencing skills; ability to push back professionally and propose workable alternatives - Clear, concise written and verbal communication with strong facilitation and client-facing skills - Sound judgment, attention to detail, and disciplined quality-control practices - Data literacy and proficiency with dashboards, spreadsheets, trends, and operational metrics - Strong understanding of clinical trial operations including study start-up, site activation, screening, enrollment, amendments, and closeout - Ability to learn complex systems and apply configurable business rules accurately - Strong collaboration, accountability, adaptability, and prioritization across multiple global studies and time zones

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