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 documents to assess the application of Labcorp Smart Supply.

• Identify study characteristics that impact kit supply and determine the scope of services, assumptions, limitations, risks, and mitigation strategies.

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

• Question requests or assumptions that may heighten supply risk, increase kit waste, or lead to process inefficiencies, while suggesting alternative solutions.

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

• Customize supply strategies based on country, site, patient demographics, visit types, or kit categories.

• Set up and manage Smart Supply services, including study parameters, resupply guidelines, exclusions, service dates, and quality control settings.

• Conduct quality assurance checks and peer reviews prior to activation; assess system-generated orders and rectify errors or supply risks.

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

• Analyze trends, pinpoint supply risks and process deficiencies, and revise strategies in response to changing study conditions.

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

• Coordinate corrective measures, escalations, and client communication.

• Assess kit utilization, waste, ordering behavior, enrollment, site actions, and service performance through dashboards, trackers, and source data.

• Deliver study-specific training and support to clients and both internal and external study collaborators.

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

• Coordinate responsibilities, timelines, handoffs, and issue resolution across global teams and various time zones.

⛳️ Requirements

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

• A minimum of 10 years of relevant 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 processes, or study-specific supply forecasting.

• Proficient understanding of how therapeutic areas, patient pathways, study phases, and site operational models influence recruitment, visit execution, and kit demand.

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

• Proven experience in facilitating client meetings, delivering training, conducting quality reviews, and managing operational risks or changes within a regulated setting.

• Advanced critical thinking skills and the ability to connect study design, patient flow, site activities, enrollment, logistics, system logic, and operational consequences.

• Strong constructive challenge and influencing abilities.

• Excellent written and verbal communication skills, showcasing clarity, conciseness, confidence, and strong facilitation skills in client-facing situations.

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

• Proficient in data interpretation, including dashboards, spreadsheets, trends, exceptions, and operational metrics.

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

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

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

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• A supportive and inclusive work environment.

• Flexible work hours and the possibility of remote work.

• Access to cutting-edge technology and resources.