Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning & Analytics as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics to improve predictability and enable earlier operational intervention. The position partners closely with Clinical Operations leadership and cross-functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.

Key Responsibilities

• Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
• Develop data-driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
• Build scenario models and planning outputs to support base and best case operational strategies and contingency planning.
• Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
• Partner with study teams, CROs, and cross-functional stakeholders to pressure-test trial assumptions and refine country and site strategies.
• Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
• Translate study and portfolio performance data into actionable insights and executive-ready recommendations for senior leadership.
• Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
• Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross-study consistency.
• Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
• Performs other duties as required.
• Works closely with the Sr. Director and VP of Clinical Operations. Clinical Operations Capabilities & Scalability and collaborates with Clinical Operations study teams, Clinical Development, IT, ITQA Biostatistics, Regulatory, Project Management, Procurement, Finance, QA, and CRO/vendor.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
• Experience working with data sources to inform trial forecast modeling
• Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
• Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
• Experience building dashboards, models, or analytics to support clinical trial execution preferred.
• Oncology, cell therapy, or early-phase clinical development experience preferred.
• Ability to travel as necessary (approximately 10%).
• Knowledge/familiarity with tools to enable trial forecasting and modeling.
• Strong critical thinking, analytical, strategic planning, and problem-solving skills.
• Effective oral, written, and interpersonal communication skills with strong presentation capability.
• Forward and critical thinker with ability to translate data into decisions.
• Strong organizational and project management skills and the ability to multitask.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
• Working knowledge of GCP, FDA, and ICH Guidelines.

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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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Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

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Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor)  as part of the Clinical Operations team based Remotely.

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.
The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross-functional study teams.

Key Responsibilities

Clinical Trial Operations Support

• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance with ICH-GCP and applicable regulatory requirements.

Documentation & TMF Management

• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.

End-to-End Trial Coordination

•  Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.

Regulatory & Compliance Support

• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.

Meeting & Communication Coordination

• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.

Tracking, Reporting & Data Support

• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.

Site & Vendor Support

• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.

Problem Solving & Continuous Improvement

• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.

Training & Mentorship

• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred.
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

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Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based remotely. 

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.

The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross functional study teams.

Contract Duration: 12 months

Key Responsibilities

Clinical Trial Operations Support
• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance
with ICH-GCP and applicable regulatory requirements.
Documentation & TMF Management
• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.
End-to-End Trial Coordination
• Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.
Regulatory & Compliance Support
• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.
Meeting & Communication Coordination
• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.
Tracking, Reporting & Data Support
• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.
Site & Vendor Support
• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.
Problem Solving & Continuous Improvement
• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.
Training & Mentorship
• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

Education
• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.

Experience
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology and/or Autoimmune Disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
Skills & Competencies
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fastpaced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
Technical Skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

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

Role Overview

The Site Contracts & Payments Manager is responsible for site contracting and investigator payment process oversight and management, and vendor due diligence across Legend pipeline studies. The role serves as a central point of accountability for improving operational effectiveness, financial discipline, and sponsor-CRO-site workflow alignment for site contracting and payment processes.

Key Responsibilities

• Partner with CROs to develop and oversee process workflows, and create visibility into site contract and investigator payment workflow efficiency across studies.
• Partner with CROs, AP, Procurement, Finance, Legal, and study teams to align process workflows, identify gaps, and improve efficiency in contracting and payment execution.
• Monitor key milestones, bottlenecks, and escalations affecting site startup experience for contracting, payment timeliness, and financial predictability.
• Support reconciliation, issue resolution, and continuous improvement related to site contracting and investigator payment operations.
• Coordinate vendor due diligence and risk assessment activities with Procurement, Finance, QA, and other stakeholders.
• Performs other duties as required.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, business, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.
• Strong experience in vendor oversight, outsourcing, site contracts, investigator payments, or related operational functions required.
• Experience working cross-functionally with AP, Procurement, Finance, and Legal required.
• Experience working in SAP/4 Hanna preferred.
• Experience establishing KPIs and oversight models preferred.
• Oncology, cell therapy, or early-phase clinical operations experience preferred.
• Ability to travel as necessary (up to 10%).
• Effective oral, written, and interpersonal communication skills.
• Strong process management, organizational, and problem-solving skills.
• Ability to identify operational risk and drive practical mitigation strategies.
• Strong project management skills and the ability to manage multiple priorities.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project).
• Working knowledge of GCP, FDA, and ICH Guidelines.

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