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Labcorp, a global leader in laboratory services, is seeking a Clinical Trials Monitor II to join the Smart Supply team in Bengaluru. This role is responsible for developing and managing study-specific strategies to ensure clinical trial kits are available when and where needed while minimizing inventory waste.
Key Responsibilities:
Study Feasibility & Protocol Analysis: Review clinical trial protocols, visit schedules, enrollment assumptions, and country requirements to determine how Labcorp Smart Supply should be deployed. Identify study characteristics affecting kit supply, such as enrollment patterns, treatment groups, and protocol amendments.
Client Consultation & Operational Leadership: Lead discussions with sponsor study teams on supply strategy, start-up quantities, and resupply approaches. Challenge requests that could increase supply risk or waste, and recommend practical alternatives. Translate complex clinical and operational information into clear recommendations for stakeholders.
Start-Up & Resupply Strategy Design: Develop study-specific strategies based on expected enrollment, site activation plans, lead times, and study design. Design ongoing resupply approaches accounting for patient demand, expiration, shipping constraints, and study risk. Tailor strategies by country, site, patient group, or kit type as needed.
System Configuration & Quality Control: Configure and maintain Smart Supply services in internal systems. Perform detailed quality checks and peer reviews of supply strategies before activation. Monitor initial system-generated orders and investigate errors or supply risks.
Active Study Monitoring & Optimization: Monitor enrollment, site activity, kit inventory, orders, and key milestones. Analyze trends to identify supply risks, configuration gaps, or waste-reduction opportunities. Adjust strategies as study conditions change, including protocol amendments and end-of-enrollment activities.
Exception & Issue Management: Investigate system exceptions, failed orders, and data issues. Determine and coordinate corrective actions, including system updates, order intervention, or client communication. Make timely, risk-based decisions in ambiguous situations.
Performance Analysis & Continuous Improvement: Use dashboards and source data to evaluate kit utilization, waste, and service performance. Provide recommendations based on operational experience and stakeholder feedback.
Training & Cross-Functional Coordination: Provide study-specific training to clients and internal partners. Create and maintain accurate documentation, risk logs, and amendment records. Coordinate across global teams and time zones.
Work Schedule: Rotational shift (AM: 05:30–14:30 or PM: 14:00–23:00)
Requirements:
Minimum Qualifications:
- Bachelor's degree in life sciences, clinical research, healthcare, pharmacy, nursing, business, supply chain, or related field (equivalent relevant experience may be considered)
- Minimum 3 years of relevant experience in clinical trial operations, central laboratory operations, global monitoring, study management, clinical supply, or related operational role
Preferred Qualifications:
- Experience in clinical trial kit supply, central laboratory services, investigator-site operations, patient recruitment/enrollment workflows, or study-specific supply forecasting
- Working knowledge of how therapeutic area, patient pathway, study phase, and site operating model affect recruitment, visit execution, and kit demand
- Experience with rule-based operational services, workflow tools, or clinical systems
- Experience facilitating client meetings, delivering training, completing quality reviews, and managing operational risk in a regulated environment
Key Competencies:
- Advanced critical thinking and ability to connect study design, patient flow, site activity, enrollment, logistics, and operational impact
- Constructive challenge and influencing skills; ability to push back professionally and propose workable alternatives
- Clear, concise written and verbal communication with strong facilitation and client-facing skills
- Sound judgment, attention to detail, and disciplined quality-control practices
- Data literacy and proficiency with dashboards, spreadsheets, and operational metrics
- Strong understanding of clinical trial operations, including study start-up, site activation, screening, enrollment, amendments, and closeout
- Ability to learn complex systems and apply configurable business rules accurately
- Strong collaboration, accountability, adaptability, and prioritization across multiple global studies and time zones
