Manager, Sample Management Operations

Legend Biotech is seeking a Manager, Sample Management Operations as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sample Management Operations Manager is responsible for overseeing end-to-end sample management across Legend pipeline studies. The role strengthens visibility, accountability, and coordination across sites, CROs, central labs and specialty labs.

Key Responsibilities

• Manage the operating model for sample management across current and future studies.
  
• Map and standardize workflows across sites, CROs, central labs, specialty labs, the sample management vendor, and sponsor stakeholders.
  
• Create visibility into critical handoffs, chain of custody, issue resolution, reconciliation activities, and operational dependencies.
  
• Monitor operation trends and proactively identify operational risks and mitigation plans that reduce delayed, lost, or poorly coordinated samples.
  
• Serve as lead for sample tracking and oversight capabilities enabled through the sample management vendor.
  
• Work with study teams and external vendors to reduce delays, missing data, and operational burden at sites.
  
• Support readiness for inspections, audits, and quality reviews related to sample operations.
  
• Create playbooks, templates, and role clarity to support consistent execution across studies.
  
• Capture lessons learned and apply them to future study planning and execution.
  
• Performs other duties as required.
• Works closely with Sr. Director of Clinical Operations and collaborates with Clinical Operations, Data Management, QA, ITQA, central labs, specialty labs, CROs, sites, and other cross-functional stakeholders.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.
  
• Experience in clinical operations with exposure to sample management, lab operations, or related oversight functions required.
  
• Experience developing or improving complex operational workflows strongly preferred.
  
• Experience with central labs, specialty labs or sample tracking solutions preferred.
  
• Oncology, cell therapy, or early-phase clinical development experience preferred.
  
• Ability to travel as necessary (up to 10%).
• Effective oral, written, and interpersonal communication skills.
• Strong organizational, project management, and issue resolution skills.
  
• Ability to identify operational risk and develop practical mitigation strategies.
  
• Strong attention to detail while maintaining end-to-end process visibility.
  
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project and applicable operational tools).
  
• Working knowledge of GCP, FDA, and ICH Guidelines.

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