Global Clinical Study Ops Associate

BeOne Medicines; United States; On-site; USD 72,800 - 97,800; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Job summary

BeOne Medicines is seeking aClinical Study Support professional to assist the Global Clinical Study Manager in delivering global studies with quality and on-time performance. This role focuses on coordinating cross-functional teams, managing study systems (eTMF, CTMS), and preparing communications for the CST.

The ideal candidate has a science/healthcare background and at least one year of clinical research experience, with strong MS Office skills and knowledge of regulatory guidelines.

Qualifications

• Bachelor or higher degree in a scientific or healthcare discipline is required, higher degree preferred.
• 1+ years of experience in clinical research within Biotech, Pharma or CRO industry.
• Knowledge of clinical operations methodologies and regulatory guidelines (ICH-GCP).

Responsibilities

• Supports the Global Clinical Study Manager in global study delivery and ensures quality, timelines, and budget.
• Supports study planning, site coordination, meetings and cross-functional collaboration.
• Maintains study systems (eTMF/CTMS) and distributes study information to CST.
• Prepares study newsletters and manages TMF review and QC activities.
• Assists with study drug forecasts and overall study drug supply activities.
• Supports data cleaning and follow-up of outstanding information.

Skills

Clinical operations knowledge

MS Office proficiency

Collaboration skills

Education

Bachelor or higher in science/healthcare

Tools

MS Office (Excel/PowerPoint)

eTMF

CTMS

Job description

BeOne Medicines is seeking aClinical Study Support professional to assist the Global Clinical Study Manager in delivering global studies with quality and on-time performance. This role focuses on coordinating cross-functional teams, managing study systems (eTMF, CTMS), and preparing communications for the CST.

The ideal candidate has a science/healthcare background and at least one year of clinical research experience, with strong MS Office skills and knowledge of regulatory guidelines.