Clinical Trials Monitor II

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

📋 Description

• Formulate and oversee study-specific strategies to guarantee that clinical trial kits are available at the right times and locations while reducing unnecessary inventory and waste.

• Examine clinical trial protocols, visit schedules, enrollment expectations, country requirements, and study documentation to evaluate the applicability of Smart Supply.

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

• Create start-up kit strategies based on enrollment and screening expectations, site activation timing, country lead times, and study design.

• Develop and sustain ongoing resupply strategies that consider patient demand, expiration dates, shipping lead times, and study risks.

• Configure and manage Labcorp Smart Supply services, including study parameters, resupply rules, exclusions, service dates, and quality-control settings.

• Conduct quality checks and peer reviews prior to activation; review system-generated orders and resolve errors and supply risks.

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

• Analyze trends and modify strategies as study conditions evolve.

• Investigate exceptions, failed or unmatched orders, data issues, and other interruptions in automated resupply.

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

• Assess kit utilization, waste, ordering activities, enrollment patterns, site behaviors, and service performance.

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

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

• Manage responsibilities, timelines, handoffs, issue resolutions, and backup coverage across global teams and different time zones.

⛳️ Requirements

• A Bachelor's degree in life sciences, clinical research, healthcare, pharmacy, nursing, business, supply chain, or a related field; equivalent relevant experience may be considered 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 similar operational role.

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

• Proficient understanding of 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, deliver training, perform quality reviews, and manage operational risks or changes in a regulated environment.

• 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, explain evidence and trade-offs, and suggest viable alternatives.

• Clear, concise, and confident written and verbal communication skills, with strong facilitation and client-facing capabilities.

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

• Data literacy and proficiency in analyzing dashboards, spreadsheets, trends, exceptions, and operational metrics.

• Comprehensive understanding of clinical trial operations, including 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 Employer principles.

• Promotion of inclusion and belonging within the workforce.

• Consideration for qualified applicants without discrimination.

• Assistance and accommodations for disability applications.