创新药(专精特新)企业
临床项目经理-base美国
生命科学
临床
美国
3-5年
本科
¥45 - 70K14薪
公司介绍
原研技术平台,在心血管,肿瘤,免疫等领域有管线布局,中美澳同步研究,IPO后期,预期新品明年商业化。
职位描述
Local Trial Manager position
Responsibilities:
Responsible for running the US portion of global trials, working with cross functional teams. Providing budget, and vendor oversite.
Providing Site oversite, site training, Onboarding, Identification – selection support
Responsible for reviewing trip reports.
Monitoring plan: Witten or contributed, updated, and made changes
Responsible for cross-functional team oversite and training for CRA’s, CTM’s, IH-CRA’s
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
Supports country-level operational planning and accountable for site selection within assigned country/-ies.
Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
Supports and contributions to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
职位要求
Qualifications:
Minimum 3 years’ experience running local/regional/global trials in a CRO, Pharmaceutical or Biotechnology environment
Bachelor’s degree
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