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-specific requirements, and study documentation to ascertain the appropriate use of Labcorp Smart Supply.

• Identify characteristics of the study that may impact kit supply and assess service scope, assumptions, limitations, risks, and mitigation strategies.

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

• Challenge requests or assumptions that could elevate supply risk, cause kit waste, or lead to process inefficiencies, while offering alternative solutions.

• Develop tailored start-up kits and ongoing resupply strategies specific to each study.

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

• Conduct quality checks and peer reviews prior to activation.

• Review system-generated orders and pending requests; investigate and rectify errors and supply risks.

• Monitor enrollment, site activity, kit inventory, orders, expiration dates, notifications, and key study milestones.

• Analyze trends, identify supply risks and process improvements, and adjust strategies in response to changing study conditions.

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

• Coordinate corrective actions, escalations, and communications with clients.

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

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

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

• 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 professional experience may be accepted in alignment with 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 processes, 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.

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

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

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

• Skills in constructive challenge and influencing.

• Excellent written and verbal communication skills, strong facilitation and client-facing abilities, and the capacity to simplify complex information.

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

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

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

• Capability 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

• Equal Opportunity Employer.

• Accommodation assistance for individuals with disabilities.

• Consideration for qualified applicants without regard to protected characteristics.

• Privacy and personal data protection information provided.