Remote Project Data Manager - Clinical Trials Lead

BeiGene, Ltd.; Northern (KY); Hybrid; USD 123,000 - 163,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness program

Job summary

BeOne Medicines Ltd. is seeking a Project Data Manager to own the end-to-end clinical data management process for trials from startup through database lock, including CSR support.

The role requires coordinating with internal teams and CROs to meet timelines and data quality standards. The candidate will oversee eCRF development, data validation, SDTM/CDASH alignment, and UAT activities, while mentoring junior data managers and contributing to process improvements.

Qualifications

• 6+ years of experience in clinical data management in the pharmaceutical/biotechnology industry.
• Oncology experience preferred.
• Understanding of ICH and regulatory environment as it pertains to data management.
• Experience with SDTM/CDASH.
• Strong project management skills.
• Excellent written, verbal and organizational skills.
• Ability to work in cross-functional team-oriented environments.

Responsibilities

• Lead studies within a program.
• Oversee data managers on studies either in-house or CRO/FSP resources.
• Serve as active member of Clinical Study Teams.
• Collaborate with other functions to develop timelines and ensure data management deadlines are met.
• Define external data transfer specifications and work with external vendors on timelines and data deliverables.
• Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Drive User Acceptance Testing (UAT) for trial database builds and modifications.
• Develop study-specific eCRF Completion Guidelines and Data Management Plans.
• Create and maintain data management documentation and SOPs.
• Coordinate with Pharmacovigilance on SAE reconciliation.
• Mentor junior Clinical Data Managers.

Skills

Detail-oriented

Strong project management

Education

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

Tools

Medidata Rave

EDC systems

Microsoft Office

Job description

BeOne Medicines Ltd. is seeking a Project Data Manager to own the end-to-end clinical data management process for trials from startup through database lock, including CSR support.

The role requires coordinating with internal teams and CROs to meet timelines and data quality standards. The candidate will oversee eCRF development, data validation, SDTM/CDASH alignment, and UAT activities, while mentoring junior data managers and contributing to process improvements.