Regional Clinical Trial Operations Associate

BeOne Medicines Ltd.; United States; Vor Ort; USD 84.000 - 114.000; Vollzeit

Benefits dieser Stelle

Medical benefits

401(k)

PTO & Wellness

Zusammenfassung

BeOne Medicines Ltd. is seeking an experienced clinical study support professional in the United States. You will assist in regional study delivery, start-up activities, document management and TMF maintenance, working with CRAs and SSUSs to ensure quality and timelines.

Strong knowledge of clinical operations and regulatory guidelines is essential. The role requires 2+ years in clinical research, a bachelor’s degree in a scientific or healthcare field, and proficiency with MS Office, eTMF and

Qualifikationen

• 2+ years of clinical research experience in biotech, pharma or CRO
• Bachelor's degree in a scientific or healthcare discipline is required
• Knowledge of ICH guidelines and regulatory expectations

Aufgaben

• Support Regional Clinical Study Manager in country and regional study delivery
• Assist CRAs and SSUSs with study start-up, CTMS updates and document management
• Coordinate study-related activities, meetings and documentation across regions
• Maintain TMF quality through file creation, filing and QC checks
• Assist with vendor management, budgets, and payments follow-up

Kenntnisse

Clinical operations experience

Ausbildung

Bachelor-level degree in science/healthcare

Tools

MS Office

eTMF

CTMS

Jobbeschreibung

BeOne Medicines Ltd. is seeking an experienced clinical study support professional in the United States. You will assist in regional study delivery, start-up activities, document management and TMF maintenance, working with CRAs and SSUSs to ensure quality and timelines.

Strong knowledge of clinical operations and regulatory guidelines is essential. The role requires 2+ years in clinical research, a bachelor’s degree in a scientific or healthcare field, and proficiency with MS Office, eTMF and