Global Clinical Study Operations Associate

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

BeOne Medicines Ltd. in San Mateo, CA seeks a Clinical Operations support professional to help manage global study delivery and ensure quality within timelines and budgets.

You will assist in coordinating CST meetings, setting up studies in eTMF/CTMS, and maintaining study information. The role involves collaboration with regional teams and ensuring regulatory compliance throughout the study lifecycle.

Qualifications

• 1+ years of experience in clinical research within Biotech, Pharma or CRO industry.
• Knowledge of clinical operations methodologies and regulatory guidelines (ICH-GCP).
• Ability to organize cross-functional CST meetings and coordinate study activities.
• Proficiency with study setup in systems (eTMF, CTMS) and data management.

Responsibilities

• Coordinate cross-functional CST meetings and collaborate with stakeholders globally.
• Support study setup in eTMF, CTMS and related systems; ensure up-to-date study information.
• Manage study access and user accounts across the study lifecycle.
• Assist in developing and tracking study plans and deliverables.
• Support TMF creation, maintenance, and QC per plan.
• Assist with study drug forecasts and global supply activities.
• Prepare metrics and newsletters; communicate study status to team.
• Support data cleaning and follow-up of outstanding information.

Skills

Cross-functional leadership

Planning

Quality management

Budget management

Vendor management

MS Office proficiency

Travel willingness

Clinical operations knowledge

Education

Bachelor or higher in science/healthcare

Higher degree preferred

Tools

eTMF

CTMS

SharePoint

Job description

BeOne Medicines Ltd. in San Mateo, CA seeks a Clinical Operations support professional to help manage global study delivery and ensure quality within timelines and budgets.

You will assist in coordinating CST meetings, setting up studies in eTMF/CTMS, and maintaining study information. The role involves collaboration with regional teams and ensuring regulatory compliance throughout the study lifecycle.