Sr. Data Manager

Legend Biotech is seeking Senior Data Manager as part of the Clinical team based in Somerset, NJ. 

Role Overview

We are seeking an experienced Senior Data Manager to join our organization as a full-time, strategic team member. The ideal candidate will bring significant expertise in cell and gene therapy, particularly CAR-T and solid tumor oncology, combined with strong leadership in data management strategy, CRO oversight, and Medidata Rave operations.

This highly visible role is responsible for end-to-end clinical data management activities across complex global trials—from study start-up through database lock and submission—while ensuring data accuracy, consistency, and compliance. As a key cross-functional partner, you will contribute to operational excellence, regulatory success, and the delivery of innovative therapies to patients.

The Senior Data Manager will also mentor junior staff, drive continuous process improvement, and play a critical role in building a scalable infrastructure to support a growing development pipeline.

Key Responsibilities  

•  Strategic Leadership & Study Oversight:
  • Serve as the Data Management SME within the organization, providing leadership across multiple clinical programs.
  • Act as the primary point of contact for internal stakeholders (Clinical Operations, Clinical Science, Biostatistics, Regulatory, IT) and external CROs.
  • Plan, coordinate, and deliver high-quality, reliable clinical trial data aligned with protocol and regulatory expectations.
  • Lead and manage full-scope data management activities, including EDC design, CRF development, edit check specifications, and validation planning.
  • Partner closely with external vendors supporting additional data capture systems (eCOA, external lab data, Safety Gateways, etc.).
• Vendor and CRO Management:
  • Oversee third-party vendors and CROs to ensure delivery against quality, timeline, and budget commitments.
  • Track data management milestones, escalate risks/issues proactively, and ensure resolution in collaboration with clinical study teams.
  • Contribute to vendor selection, qualification, contract negotiation, and ongoing governance based on outsourcing metrics and KPIs.
• Quality Management & Data Integrity:
  • Enforce data standards, conventions, and best practices to ensure data consistency, quality, and regulatory compliance.
  • Author and maintain critical study documents, including Data Management Plans (DMPs), Data Review Plans (DRPs), Data Validation Specifications (DVSs), and Data Transfer Agreements (DTAs).
  • Chair Data Quality Review (DQR) meetings to drive ongoing review of trial data currency, completeness, and quality.
  • Ensure clean-up and reconciliation of external data sources with EDC; monitor data queries, resolution metrics, and issue management.
• Technical Ownership:
  • Lead the setup, UAT testing, configuration, and maintenance of Medidata Rave EDC systems.
  • Own internal clinical data repositories, facilitate clean data transfers between vendors and Sponsor systems, and coordinate database archiving activities.
  • Collaborate with IT and system implementation teams to ensure compliant, efficient data architecture for ongoing and future trials
• Compliance and Regulation Support:
  • Ensure full compliance with ICH-GCP, FDA, EMA regulations, internal SOPs, and data privacy standards.
  • Lead or support Health Authority inspections and clinical trial audits from a data management perspective.
  • Implement corrective and preventive actions (CAPAs) as needed following inspections or audit findings.
• Team Leadership and Mentorship:
  • Provide oversight, coaching, and professional development to direct reports (Data Managers, Associate Data Managers).
  • Manage resource planning for assigned projects and therapeutic areas.
  • Lead internal training on evolving data management standards (e.g., CDISC, SDTM) and contribute to the broader functional excellence strategy.
• Continuous Improvement and Innovation:
  • Identify opportunities for process optimization within data management activities.
  • Lead or participate in cross-functional initiatives aimed at enhancing operational efficiency and trial data quality.

Requirements

• Bachelor’s degree in Life Sciences, Biostatistics, Computer Science, or related discipline (master’s preferred).
• Minimum of 10 years of clinical data management experience, including leadership of cell therapy, CAR-T, and oncology trials.
• Expert proficiency with Medidata Rave; experience with additional EDC systems and integration platforms highly desirable.
• Strong knowledge of clinical trial data flows, including CDASH/CDISC standards, SAE reconciliation, external data handling, and submission deliverables.
• In-depth understanding of GCP, ICH guidelines, FDA/EMA regulations, and global regulatory submission processes (NDA, BLA, MAA).
• Proven track record managing global CROs/vendors, including issue escalation, risk mitigation, and milestone delivery tracking.
• Strong project management, organizational, analytical, and communication skills.
• Prior experience in emerging or mid-size biotech environments preferred, with ability to scale operations in dynamic settings.

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