Full-Time

Senior Data Manager

Contract

Posted on 3/28/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Biotechnology

Senior

Somerset County, NJ, USA

Required Skills
Communications
Management
Data Analysis
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.
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 to ensure integrated and streamlined data management.
  • Lead and contribute to the development, review, and editing of critical data management documents.
  • Organize, maintain, and optimize internal data repositories and data transfers.
  • Provide training and support to internal teams on data management systems and processes.
  • Identify, troubleshoot, and resolve data-related issues, implementing corrective measures.
  • Ensure compliance with industry standards, regulatory requirements, and organizational policies.

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

21%

1 year growth

50%

2 year growth

132%
INACTIVE