Clinical Trials Monitor II

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

📋 Description

• Analyze clinical trial protocols, visit schedules, enrollment assumptions, country requirements, and study documentation to evaluate the application of Labcorp Smart Supply.

• Determine study characteristics that impact kit supply and establish the service scope, 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.

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

• 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 pending requests; investigate and rectify errors and supply risks.

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

• Analyze trends and modify supply strategies as study conditions evolve.

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

• Coordinate corrective actions, escalations, and client communications.

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

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

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

• Coordinate roles, timelines, handoffs, and issue resolutions 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; relevant equivalent 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 similar operational role.

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

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

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

• Proficiency in facilitating client meetings, delivering training sessions, performing quality reviews, and managing operational risk or changes in a regulated environment.

• Advanced critical thinking skills with the ability to link study design, patient flow, site activity, enrollment, logistics, system logic, and operational impact.

• Strong skills in constructive challenge and influence.

• Excellent written and verbal communication abilities, with strong facilitation and client engagement skills.

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

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

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

• Capacity 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

• Inclusive and non-discriminatory workplace