Clinical Trials Monitor II

This is a fully remote position, open to applicants in India.

📋 Description

• Evaluate clinical trial protocols, visit schedules, enrollment assumptions, country requirements, and study documentation to assess the applicability of Labcorp Smart Supply.

• Identify study factors influencing kit supply, including enrollment trends, visit schedules, treatment groups, specialty testing, country limitations, site models, and protocol modifications.

• Define the scope of service across various studies, kits, sites, countries, regions, or visits, and document assumptions, limitations, risks, and mitigations.

• Facilitate discussions with clients and study teams regarding supply strategy, initial quantities, resupply methods, service scope, risks, and performance metrics.

• Challenge assumptions that might elevate supply risks, cause kit waste, or lead to process inefficiencies, and suggest feasible alternatives.

• Create study-specific strategies for start-up kits and ongoing resupply.

• Configure and manage Labcorp Smart Supply services, covering study parameters, resupply regulations, exclusions, service dates, and quality control settings.

• Conduct quality checks and peer reviews prior to activation; examine initial system-generated orders and address errors or supply risks.

• Oversee enrollment, site activities, kit inventory, orders, expirations, notifications, and study milestones.

• Assess trends, recognize risks and opportunities to mitigate waste, and modify strategies as study conditions evolve.

• Investigate exceptions, failed or unmatched orders, status changes, data discrepancies, and conditions disrupting automated resupply.

• Coordinate corrective measures, escalations, system updates, order interventions, and client communications.

• Analyze kit utilization, waste, ordering activities, enrollment, site behaviors, and service performance through dashboards, trackers, and source data.

• Deliver study-specific training and support to clients and study partners.

• Maintain study documentation, configuration records, trackers, client materials, risk logs, and amendment documentation.

• Coordinate responsibilities, timelines, transitions, issue resolutions, and backup coverage among global teams and across time zones.

⛳️ Requirements

• Bachelor's degree in life sciences, clinical research, healthcare, pharmacy, nursing, business, supply chain, or a related discipline; equivalent relevant experience may be accepted per company policy.

• At least 10 years of pertinent experience in clinical trial operations, central laboratory operations, global monitoring, study management, clinical supply, or a related operational function.

• Background in clinical trial kit supply, central laboratory services, investigator-site operations, patient recruitment or enrollment processes, or study-specific supply forecasting.

• Familiarity with how therapeutic areas, patient pathways, study phases, and site operating models can influence recruitment, visit execution, and kit demand.

• Experience with rule-based operational services, workflow tools, or clinical systems.

• Proven ability to facilitate client meetings, provide training, perform quality reviews, and manage operational risk or changes in a regulated setting.

• Advanced critical thinking skills and the capability to connect study design, patient flow, site activity, enrollment, logistics, system logic, and operational impacts.

• Strong constructive challenge and influencing abilities, including the capacity to professionally push back, clarify evidence and trade-offs, and propose viable alternatives.

• Excellent written and verbal communication skills, with strong facilitation and client-facing capabilities.

• Good judgment, attention to detail, and disciplined quality control practices.

• Data literacy and the ability to interpret dashboards, spreadsheets, trends, exceptions, and operational metrics proficiently.

• Comprehensive understanding of clinical trial operations, encompassing study start-up, site activation, screening, enrollment, patient visits, amendments, closeout, site challenges, shipping constraints, and clinical supply risks.

• Ability to learn complex systems and accurately apply configurable business rules.

• Strong collaboration, accountability, adaptability, and prioritization skills across multiple global studies and time zones.

🏝️ Benefits

• Commitment to Equal Opportunity Employment, ensuring consideration without regard to legally protected characteristics.

• Accessibility assistance and accommodations available for applicants with disabilities.

• Opportunity to engage in meaningful work, advance your career, and make a significant impact on people's health.