Regional Clinical Trial Operations Specialist

BeOne Medicines Ltd.; San Mateo (CA); Presencial; USD 60 000 - 90 000; Tempo integral

Resumo da oferta

BeOne Medicines Ltd. is seeking a Regional Trial Support professional to assist in regional and country study delivery, including feasibility, start-up, document generation and TMF maintenance. You will collaborate with CRAs, SSUSs and study teams to ensure regulatory compliance and timely execution.

This role requires knowledge of clinical operations, 1+ year of clinical research experience, and the ability to travel as needed. A scientific/healthcare degree is preferred.

Qualificações

• Knowledge of clinical operations methodologies and regulatory requirements.
• 1+ year of experience in clinical research within biotech, pharma or CRO.
• Willingness to travel occasionally.

Responsabilidades

• Supports regional study delivery across feasibility, start-up, documentation and participant enrollment.
• Assists CRAs/SSUSs with CTMS updates, ISF prep, eTMF filing and site-level document review.
• Maintains regional/country SharePoint folders and ensures information is up to date.
• Supports study start-up in region/country and coordinates investigator meetings.
• Supports TMF creation and QC at country/site level; helps with questions from trial sites.
• Contributes to data cleaning and follow-up of outstanding regional information.
• Assists with budget setup, PO processing and payments follow-up.

Formação académica

Bachelor’s Degree (science/healthcare)

Higher Degree preferred

Ferramentas

MS Office

eTMF

CTMS

Descrição da oferta de emprego

BeOne Medicines Ltd. is seeking a Regional Trial Support professional to assist in regional and country study delivery, including feasibility, start-up, document generation and TMF maintenance. You will collaborate with CRAs, SSUSs and study teams to ensure regulatory compliance and timely execution.

This role requires knowledge of clinical operations, 1+ year of clinical research experience, and the ability to travel as needed. A scientific/healthcare degree is preferred.