北京招聘

Major Responsibilities

· Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require

· Conducts co-monitoring visits, if required

· 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

  Qualification

· 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

· 3 years or more 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。