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更新于 7月25日
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臨床項目經(jīng)理PM(J10435)

3-4萬
  • 廣州天河區(qū)
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

臨床試驗臨床項目管理ADC項目
崗位職責:
?Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).
?Leads study team meetings.
?Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.
?Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.
?Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.
?Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.
?Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.
?Provides oversight of CRO performance throughout study implementation.
?Develops study training and may also coordinate/deliver training, as appropriate.
?Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.
?Manages and tracks trial enrollment.
?Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.
?Anticipates, manages, and escalates Issues as appropriate.
?Maintains and archives at trial level documentation.
?Partners with study team in the management of data locks (final and interim) and site closure.
任職要求:
?Bachelor
s degree in a scientific or health related field.
?Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, NMPA regulations.
?Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.
?Excellent verbal and written communication skills.
?Excellent office computer skills, including experience with clinical databases.
?Effective cross-functional team player with ability to work in a team environment.
?Demonstrated leadership skills.
?Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.
?Experienced in serving on product development teams and understands the product development lifecycle.

工作地點

廣州天河區(qū)雅居樂中心

職位發(fā)布者

婁女士/HR

三日內(nèi)活躍
立即溝通
公司Logo諾誠健華
諾誠健華（上交所代碼：688428；香港聯(lián)交所代碼：09969）于2015年由世界著名結構生物學家施一公院士和生物醫(yī)藥行業(yè)卓越的科學家兼企業(yè)家崔霽松博士聯(lián)合創(chuàng)立。作為一家植根于中國且具有全球視野的新藥創(chuàng)制公司，諾誠健華以“科學驅(qū)動創(chuàng)新患者所需為本”為價值理念，專注于惡性腫瘤和自身免疫性疾病的創(chuàng)新藥研究和開發(fā)。經(jīng)過近十年的堅實發(fā)展，公司在各方面取得重大進展。2020年3月23日，諾誠健華成功在港交所上市，成為2020年港交所生物醫(yī)藥第*一股。2022年9月21日，諾誠健華在上海證券交易所科創(chuàng)板上市，開啟了H+A的新征程。目前，諾誠健華已經(jīng)打造了具有市場前景的強大產(chǎn)品管線，覆蓋血液瘤、實體瘤和自身免疫性疾病。諾誠健華自主研發(fā)的國家“重大新藥創(chuàng)制”專項成果——BTK抑制劑奧布替尼（商品名：宜諾凱?）目前已在中國和新加坡獲批上市并納入中國國家醫(yī)保，是中國首*個且唯*一獲批針對邊緣區(qū)淋巴瘤的BTK抑制劑；坦昔妥單抗（商品名：明諾凱?）創(chuàng)新療法已成為中國首*個獲批治療復發(fā)/難治性彌漫性大B細胞淋巴瘤（R/R DLBCL）的CD19單抗；mesutoclax（ICP-248）是中國第*一個獲得突破性療法認定（Breakthrough Therapy Designation）的BCL2抑制劑，10多款創(chuàng)新藥在臨床階段。諾誠健華已經(jīng)構建了從源頭創(chuàng)新、臨床開發(fā)、生產(chǎn)到商業(yè)化的全產(chǎn)業(yè)鏈平臺。在具有豐富研發(fā)、生產(chǎn)和商業(yè)化經(jīng)驗的管理團隊的帶領下，諾誠健華已構建起一體化的生物醫(yī)藥平臺，包括藥物晶型研究平臺、難溶性藥物增溶制劑技術研發(fā)及產(chǎn)業(yè)化平臺、生物大分子發(fā)現(xiàn)和工程化改造平臺等，加速為全球腫瘤和自身免疫性疾病患者開發(fā)并提供極具市場前景的創(chuàng)新療法。發(fā)展至今，諾誠健華現(xiàn)有員工1200多人，眾多員工擁有海外工作和世界500*強藥企工作經(jīng)驗，并擁有多名國家*級、省市級人才專家。諾誠健華在北京、南京、上海、廣州、香港和美國等多地均設有分支機構。
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