北京招聘

? Conducts monitoring (pre study, initiation, routine monitoring and closeout visit), if require
? Conducts co monitoring visits, if required
? Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
? Attends onboarding--, disease indication and project specific training and general CRA training as required
? Documents monitoring activities appropriately following ICH GCP and BeiGene standards
? Conducts Quality Oversight Visits (QOV), as requested
? Completes monitoring visit/ QOV reports timely
? Assists with investigator/site identification
? Assists site to prepare Ethics Committee submissions
? Facilitates clinical trial site contract and budget negotiation
? Manages site queries and communications
? Assists in managing clinical trials, if required
? Establishes regular lines of communication with sites and COMs
? Provides protocol and related study training to assigned sites
? Evaluates the quality and integrity of site practices escalating quality issues as appropriate
? Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
? Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
? Performs additional task as assigned
职位要求：
Additional Job Description
? Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
? Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
? 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry
? Excellent communication and interpersonal skills
? Excellent organizational skills and ability to prioritize and multi-task
? Fluent in English (writing and speaking)

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。