Regional Clinical Trial Operations Specialist

BeOne Medicines Ltd.; United States; Hybrid; USD 73,000 - 98,000; Full time

Benefits offered by this job

Equity awards

Employee Stock Purchase Plan

Job summary

BeOne Medicines Ltd. is seeking an experienced professional to support regional study delivery and coordination across feasibility, start-up and documentation.

You will assist CRAs and SSUSs with CTMS updates, ISF binder prep, document collections, and eTMF maintenance, while ensuring regulatory compliance and timely study execution. You will help organize regional and country team meetings, manage data workflows in SharePoint, and contribute to quality assurance activities and TMF filing.

Qualifications

• 1+ year of experience in clinical research within biotech, pharma or CRO.
• Knowledge of clinical operations methodologies and trial processes.
• Ability to work with regional/global teams to drive study delivery.

Responsibilities

• Supports regional study delivery across feasibility, start-up, documentation and enrollment tracking.
• Assists CRAs and SSUSs with CTMS updates, ISF binder prep, document collections and eTMF maintenance.
• Contributes to regulatory submissions preparation and TMF filing at site and country levels.
• Helps organize regional and country team meetings and maintains SharePoint folders.
• Supports data cleaning, site newsletters and follow-up on outstanding information.

Skills

Clinical operations

Regulatory knowledge

Project coordination

Cross-functional collaboration

Education

Bachelor's Degree in life sciences

Higher Degree preferred

Tools

MS Office

eTMF

CTMS

Job description

BeOne Medicines Ltd. is seeking an experienced professional to support regional study delivery and coordination across feasibility, start-up and documentation.

You will assist CRAs and SSUSs with CTMS updates, ISF binder prep, document collections, and eTMF maintenance, while ensuring regulatory compliance and timely study execution. You will help organize regional and country team meetings, manage data workflows in SharePoint, and contribute to quality assurance activities and TMF filing.