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Manager, Sample Management Operations at Legend Biotech
Somerset, New Jersey, United StatesFull-timeClinical Operations & Data AnalyticsPosted about 1 month ago
Apply with PipelineAbout the Role
<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p>
<p style="line-height: 1.2;"> </p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.</span></p>
<p style="line-height: 1.2;"> </p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is seeking a <strong>Manager, Sample Management Operations</strong> as part of the <strong>Clinical Operations</strong> team based in <strong>Somerset</strong>, <strong>NJ</strong>.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Role Overview</strong></span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage the operating model for sample management across current and future studies.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Map and standardize workflows across sites, CROs, central labs, specialty labs, the sample management vendor, and sponsor stakeholders.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Create visibility into critical handoffs, chain of custody, issue resolution, reconciliation activities, and operational dependencies.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Monitor operation trends and proactively identify operational risks and mitigation plans that reduce delayed, lost, or poorly coordinated samples.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as lead for sample tracking and oversight capabilities enabled through the sample management vendor.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work with study teams and external vendors to reduce delays, missing data, and operational burden at sites.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support readiness for inspections, audits, and quality reviews related to sample operations.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Create playbooks, templates, and role clarity to support consistent execution across studies.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Capture lessons learned and apply them to future study planning and execution.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Performs other duties as required.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></li>
</ul>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Requirements</strong></span></p>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, or related discipline. Advanced degree preferred.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in clinical operations with exposure to sample management, lab operations, or related oversight functions required.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience developing or improving complex operational workflows strongly preferred.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with central labs, specialty labs or sample tracking solutions preferred.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oncology, cell therapy, or early-phase clinical development experience preferred.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to travel as necessary (up to 10%).</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Effective oral, written, and interpersonal communication skills.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong organizational, project management, and issue resolution skills.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to identify operational risk and develop practical mitigation strategies.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong attention to detail while maintaining end-to-end process visibility.<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project and applicable operational tools).<br></span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Working knowledge of GCP, FDA, and ICH Guidelines.</span></li>
</ul>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-JR1</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Hybrid</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.</p>
<p>Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.</p>
<p>Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.</p></div><div class="title">Pay Range (Base Pay): </div><div class="pay-range"><span>$127,313</span><span class="divider">—</span><span>$167,099 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p>
<p> </p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>EEO Statement</strong></span></p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.</span></p>
<p style="line-height: 1.2;"> </p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p>
<div> </div>
<div><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For information related to our privacy notice, please review: <a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</span></div></div>
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