Senior Data Management Program Lead

beigene

United States

On-site

USD 142,000 - 187,000

Full time

4 days ago
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Job summary

BeOne is seeking an experienced Program Lead in Data Management to drive multiple clinical studies and programs, focusing on quality, timelines, and data integrity. You will oversee data managers, collaborate with CSTs and CROs, and lead initiatives to standardize processes across clinical data management functions.

The role emphasizes leading data management activities, developing EDQ databases and reports, and maintaining robust SOPs, with a strong focus on oncology and regulatory compliance.

Qualifications

  • 8+ years of experience in clinical data management in the pharmaceutical/biotechnology
  • Strong oncology experience required
  • 5+ years as Lead Data Manager
  • Good understanding of ICH and regulatory environment
  • Experience developing Data Management standards

Responsibilities

  • Lead multiple clinical studies or programs from the Data Management perspective
  • Oversee data managers to ensure timelines and data quality
  • Collaborate with CST, CROs, and central labs to support data deliverables
  • Develop EDC databases, edit checks, and reports with database builders
  • Drive process improvements and maintain Data Management SOPs/work instructions
  • Provide training on SOPs, processes, and standards
  • Ensure inspection readiness and data management compliance

Education

Bachelor's degree or equivalent in a health-related field

Tools

Medidata Rave
EDC systems
SAS Viewer
Visualization tools
MS Excel/Office

Job description

BeOne is seeking an experienced Program Lead in Data Management to drive multiple clinical studies and programs, focusing on quality, timelines, and data integrity. You will oversee data managers, collaborate with CSTs and CROs, and lead initiatives to standardize processes across clinical data management functions.

The role emphasizes leading data management activities, developing EDQ databases and reports, and maintaining robust SOPs, with a strong focus on oncology and regulatory compliance.

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