Teams at BeiGene

The Clinical Research Associate monitors oncology and hematology clinical trials at assigned sites, ensuring compliance with ICH-GCP, regulations, SOPs, quality standards, and study timelines. Responsibilities include site feasibility and selection, start-up support, investigator training, monitoring visits, regulatory and recruitment tracking, data query resolution, inspection readiness, issue escalation, and CAPA development. The CRA collaborates with clinical operations teams and sites to deliver study milestones and maintain data integrity.

Provide strategic statistical leadership for EU HTA and JCA submissions, collaborate cross-functionally and with vendors, design and review analyses and models (economic modeling, indirect comparisons, observational studies), supervise statistical programming outputs, train staff, ensure standards and readiness for EU HTA, and review vendor-supplied data and analyses.

Lead UK & Ireland regulatory strategy and submissions for oncology development and commercial products. Manage UK MAA dossiers, MHRA interactions, labeling and compliance, mentor junior staff, advise UK leadership, and represent the company at industry meetings. Ensure regulatory risk mitigation and cross-functional alignment throughout product lifecycle.