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高级临床项目管理经理(Sr.CPM,英文听说流利)

Finance
基石药业
上海-浦东新区, 中国2周前截至 2026/8/17
全职

职位描述

Responsibilities Independently lead end-to-end management of assigned clinical trials from study planning through close-out. Develop and maintain project plans, timelines, and budgets; identify risks and support mitigation strategies. Serve as the primary operational contact for vendors (e.g., CROs, SMOs, central labs), tracking performance against milestones, budget, and quality. Oversee in-house trials including site selection, initiation, and monitoring; coordinate with CRAs and resolve site-level issues as the first point of contact. Drive the study team to meet key milestones while maintaining budget and quality standards; make independent day-to-day decisions and escalate when needed. Facilitate cross-functional coordination with internal teams (Clinical Operations, Regulatory, Data Management, Biostatistics, Drug Supply, Pharmacovigilance, QA, Medical monitors). Ensure compliance with ICH-GCP, SOPs, and regulatory requirements; support audit and inspection preparation, and track CAPAs as needed. Support partner communications including status updates and issue resolution as the Clin Ops representative.

Qualifications Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred. Minimum 3 years of clinical project management experience within a pharmaceutical, biotech, or CRO; oncology experience and/or MRCT experience preferred. Fluent English speaker. Solid knowledge of GCP/ICH guidelines. Highly proactive and organized, with strong problem-solving abilities. Excellent team player.

Keywords
3年以上Data management

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