Clinical Supply Specialist(臨床供應(yīng)鏈物流專員)
職位描述
職位要求:英語口語流利,物流專業(yè)背景,至少1年物流工作經(jīng)驗(yàn),藥品運(yùn)輸物流經(jīng)驗(yàn)優(yōu)先。
*Job Description
? Maintains activities for the respective service lines and applies service line specific
duties and guidelines accordingly
? Oversees the logistics aspect of designated projects to ensure that the right supplies are
delivered to the right locations at the right time and right conditions.
? Maintains strong focus on external and internal client satisfaction.
? Provides support for development of project specific logistics strategy.
? Supports set-up of clinical trial logistics.
? Executes clinical logistics procedures for clinical trials.
? Prepares study documents and materials.
? Manages shipments regarding Order Entry, Quality Control (QC), Clinical Trial Material
Receipt Form (CTMRF), Supply Reorder Form (SRF) receipt and Resupply Fulfillment.
? Tracking and Tracing shipments.
? Customer Complaint handling
Manage inventory at investigational site for stock control, expiry date management and
replenishment
? Utilize PAREXEL systems in order to perform inventory management.
? Execute Destruction planning for customer.
? Perform recall procedure.
? Performs day-to-day communication with the logistics team, clinical team, sites and
vendors.
? Participates in regular study team and client meetings, as required.
? Tracks and reports logistics study metrics to the project team.
? Contributes to meeting study timelines and works efficiently with systems in place.
? Supports central filing and final archiving activities.
? Complies with GxP* standards, including applicable Standard Operating Procedures
(SOPs).
? Works toward and ensures he/she stays within budget / time allocated, in agreement with
the applicable Clinical Logistics Services Manager and Clinical Logistics Leader.
? Uses a positive, objective, balanced, and result-driven approach.
? Participates in other Clinical Logistics Services project activities as required.
Coordinates and performs key accountability tasks for Clinical Trial Supplies (IMP and
Non-IMP) and for Ancillary Supplies
? Complaint handling following GxP guidelines
? Complaint handling following Medical device regulations
? Perform UAT in close cooperation with eLogistics team
*Job Qualifications
Experience in clinical logistics, or related field within the biopharmaceutical industry or
in general logistics.
? Demonstrated multinational work experience.
Vocational or Bachelor degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy or
other health-related discipline, international trade or logistics business.
? Or relevant work experience / degree.
企業(yè)簡(jiǎn)介
公司簡(jiǎn)介:
國(guó)際精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系協(xié)助世界各國(guó)大藥廠從事新藥開發(fā)及臨床試驗(yàn)的臨床研究委托機(jī)構(gòu)(Contract Research Organization)。
國(guó)際精鼎臨床試驗(yàn)研究團(tuán)隊(duì)是由一群具有豐富跨國(guó)性臨床試驗(yàn)經(jīng)驗(yàn)及專業(yè)知識(shí)的精英所組成,目前已成為亞洲地區(qū)規(guī)模最大、服務(wù)項(xiàng)目最完整之專業(yè)CRO公司,幷已在業(yè)界建立高品質(zhì)的專業(yè)形象以及良好口碑。
APEX目前擁有超過300名的專業(yè)精英,服務(wù)遍及11個(gè)國(guó)家,在CRO的領(lǐng)域里已是亞洲的領(lǐng)導(dǎo)先驅(qū)。預(yù)計(jì)2007年APEX服務(wù)版圖將再擴(kuò)及2個(gè)國(guó)家、4個(gè)服務(wù)據(jù)點(diǎn),人員也將擴(kuò)增至500人。APEX重視與客戶的承諾,更重視人才的培育和養(yǎng)成,我們提供完整的教育訓(xùn)練、職涯規(guī)劃、優(yōu)于市場(chǎng)的薪資福利、良好工作環(huán)境,期許同仁與公司一同成長(zhǎng),邁向未來。
主要服務(wù)項(xiàng)目:
? 新藥開發(fā)策略的擬定與計(jì)劃
? 國(guó)際臨床試驗(yàn)規(guī)劃及整合
? 引薦、甄選試驗(yàn)計(jì)劃主持人
? 受試者同意書之設(shè)計(jì)
? 人體試驗(yàn)委員會(huì)之送審
? 最高衛(wèi)生主管機(jī)關(guān)之送審
? 臨床試驗(yàn)護(hù)理專員
? 臨床研究數(shù)據(jù)處理
? 向亞洲地區(qū)衛(wèi)生主管機(jī)關(guān)辦理新藥查驗(yàn)登記事務(wù)
? 中草藥及健康食品臨床試驗(yàn)、法規(guī)咨詢及查驗(yàn)登記
愿景(Vision):創(chuàng)造一個(gè)在亞太地區(qū)具有國(guó)際競(jìng)爭(zhēng)力的最精良CRO團(tuán)隊(duì)。
發(fā)展使命(Mission):
1 爭(zhēng)取國(guó)際大藥廠委托,執(zhí)行符合國(guó)際水準(zhǔn)的跨國(guó)性臨床試驗(yàn)。
2 協(xié)助亞太生技及制藥產(chǎn)業(yè)建立新藥開發(fā)模式,以提升產(chǎn)品研發(fā)能力,幷促使產(chǎn)品國(guó)際化。
3 以提升臨床試驗(yàn)品質(zhì)為宗旨,拓展全球市場(chǎng)為目標(biāo),整合計(jì)算機(jī)及通訊科技,在國(guó)際上提供客戶兼具成本效益及效率的臨床試驗(yàn)數(shù)據(jù)處理中心。
4 建立一個(gè)以亞洲人種高發(fā)生率疾病的基因數(shù)據(jù)庫,以提供國(guó)際性新藥研發(fā)機(jī)構(gòu)所須之基因信息,協(xié)助其縮短藥物開發(fā)時(shí)程,幷提高研發(fā)成功率。
福利制度:
.薪資:
1. 提供具競(jìng)爭(zhēng)性之薪資(含車補(bǔ)及飯補(bǔ))
.保險(xiǎn)類:
1. 社會(huì)保險(xiǎn)(依照國(guó)家規(guī)定)及住房公積金
2. 團(tuán)體保險(xiǎn)(包括壽險(xiǎn)、意外暨醫(yī)療保險(xiǎn))
.制度類:
1. 學(xué)習(xí)發(fā)展計(jì)劃 (Learning & Development): 針對(duì)個(gè)別員工之專業(yè)及興趣,設(shè)計(jì)符合其個(gè)人之生涯規(guī)劃
2. 完整的教育訓(xùn)練:每年公司均針對(duì)所有員工,提供完整之教育訓(xùn)練
3. 順暢的升遷管道及可轉(zhuǎn)調(diào)其它部門;如有職缺,亦可申請(qǐng)調(diào)至海外各子公司
.請(qǐng) / 休假制度:
1. 服務(wù)第一年即享有9天特休, 后續(xù)年休假天數(shù)則依據(jù)服務(wù)年資及公司制度而定
2. 一年可享4天不扣薪病假
職位發(fā)布企業(yè)
精鼎醫(yī)藥研究開發(fā)(上海)有限公司
企業(yè)性質(zhì):民營(yíng)企業(yè)
企業(yè)規(guī)模:50-99人
成立年份:1996
企業(yè)網(wǎng)址:www.apex-cro.com
企業(yè)地址:浦東新區(qū)
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職位發(fā)布日期: 2015-09-21