Senior Data Manager - Trenton, United States - Legend Biotech

Legend Biotech Trenton, United States

1 month ago

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Description

Legend Biotech is seeking

Senior Data Manager (Contract)

as part of the

Clinical Operations

team to be based

Remote.

Role Overview

We are currently seeking a seasoned Data Management Professional for a contract position within our team.

The ideal candidate will have in-depth experience in cell therapy, with specialized expertise in CAR-T therapy, solid tumors, leading a data management function, and expertise using Medidata Rave.

This role encompasses the management of external Contract Research Organizations (CROs), acting as a Subject Matter Expert (SME) for all data management activities, and ensuring the highest data quality and integrity across the clinical operations organization.

Key Responsibilities

Act as the primary Data Management Subject Matter Expert, providing expert guidance on data management standards, processes, and best practices.

Proactively identify risks and contribute to building systems and processes to ensure high data quality and integrity across the organization.

Oversee and manage external CROs to ensure adherence to project specifications, timelines, and quality expectations.

Develop, implement, and refine data management strategies, ensuring efficient data processing, quality checks, and reporting.

Expertly navigate Medidata Rave for data capture, validation, and analysis to uphold data accuracy and efficiency.

Engage with cross-functional teams, such as clinical operations, clinical science, clinical development, biostatistics, regulatory affairs, and IT, to ensure integrated and streamlined data management.

Lead and contribute to the development, review, and editing of critical data management documents, including but not limited to Data Management Plans (DMPs), Data Transfer Agreements (DTAs), Case Report Forms (CRFs) and other documents.

Organize, maintain, and optimize the internal data repositories and data transfers of the organization to ensure data accessibility, integrity, and compliance.

Provide comprehensive training and support to internal teams on data management systems, processes, and best practices.

Proactively identify, troubleshoot, and resolve data-related issues, implementing corrective and preventive measures as necessary.

Proficiency in both strategic thinking and operational execution is required, including the capability to identify emerging trends and pinpoint the root causes of data discrepancies to proactively address them.

Ensure strict compliance with industry standards, regulatory requirements, and organizational policies regarding data management and privacy.

Requirements

Master's degree in Life Sciences, Biostatistics, Computer Science, or a related discipline, with a preference for advanced degrees.

A minimum of 10 years of relevant data management experience in the biotech or pharmaceutical sector, with a strong emphasis on cell therapy and CAR-T therapy.

Demonstrated proficiency in Medidata Rave and familiarity with other clinical data management platforms.

Proven experience in managing external CROs and effectively collaborating with diverse, cross-functional teams.

Deep understanding of clinical trial processes, GCP, and regulatory guidelines pertaining to clinical data management.

Excellent problem-solving, organizational, and communication skills, paired with the ability to work autonomously and manage multiple priorities in a dynamic environment.

EDC / CRF development experience (building from the ground up databases) and the ability to address post-production build issues.

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