高级临床项目管理经理(Sr.CPM,英文听说流利)
基石药业职位描述
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.
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