Regional Clinical Trial Lead - Study Delivery & Ops

BeiGene, Ltd.; United States; Remote; USD 84,000 - 114,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Regional Trial Support professional to assist the Regional Clinical Study Manager in regional study delivery and ensure quality, timeliness, and budget alignment. You will support CRAs/SSUSs with CTMS updates, ISF binder prep, eTMF maintenance, and regulatory submissions.

This role requires 2+ years in clinical research, solid knowledge of ICH/GCP guidelines, and strong collaboration across regional and global teams. Travel may be limited.

Qualifications

• 2+ years of experience in clinical research within biotech, pharma or CRO.
• Knowledge of clinical operations methodologies and regulations.
• Experience with study setup, documents, and TMF processes.

Responsibilities

• Support Regional Clinical Study Manager in regional study delivery and quality.
• Assist CRAs/SSUSs with CTMS updates, ISF binder prep, and regulatory submissions.
• Coordinate regional meetings and maintain SharePoint/CTMS documentation.
• Support country-level study activities and TMF governance.
• Engage stakeholders regionally and globally to align study goals.
• Provide SME knowledge and mentor team members as needed.

Skills

Clinical research experience

Regulatory knowledge

Stakeholder collaboration

Education

Bachelor's degree

Higher Degree

Tools

MS Office

eTMF

CTMS

Job description

BeOne Medicines Ltd. is seeking a Regional Trial Support professional to assist the Regional Clinical Study Manager in regional study delivery and ensure quality, timeliness, and budget alignment. You will support CRAs/SSUSs with CTMS updates, ISF binder prep, eTMF maintenance, and regulatory submissions.

This role requires 2+ years in clinical research, solid knowledge of ICH/GCP guidelines, and strong collaboration across regional and global teams. Travel may be limited.