
Clinical Logistics Operation Leader (臨床物

職位描述
職位要求:英語口語精通,物流專業(yè)背景,熟知物流整體流程,至少3年物流工作經(jīng)驗,藥品運輸物流經(jīng)驗優(yōu)先。
*Job Description
General :
? Undertake the full range of duties relevant to the leadership, management and development of
the team to ensure their performance meets and/or exceeds the requirement meeting both the
study and their own personal goals/objectives
? Ability to lead and build rapport with a culturally diverse group at multiple levels and
disciplines
? Maintain a positive, results orientated work environment, building partnerships and modeling
teamwork, communicating to the team in an open, balanced and objective manner
? Engaging internal and external clients to develop logistics concepts and solutions in order to
meet the client’s satisfaction and meeting the profitability of the projects.
? Establish visible presence and be the main CTSL face to the sponsor and internal clients.
? Lead formal hand over meeting with the Proposal Support Operations Lead, CTSL functional
teams and other required parties to understand the scope of the work.
? Participate in regular meetings/calls with internal and external clients to ensure they are fully
informed of project progress, pro-active decisions/solutions and how the project objectives are
achieved.
? Review, overseeing and management of the resources assigned to the project to ensure the
CTSL FTE assigned is appropriate and meeting the study’s requirement.
? Develop project specific sourcing and distribution strategy /coordinates development of
Laboratory Logistics concept.
? Leading the CTSL meetings to monitor and ensure that projects is completed within budget,
schedule and according to contract specifications in accordance to the quality standards, SOPs,
ICH-GCP and/or any other guidelines to fulfil local regulations
? Ability to influence and gain collaboration from and respect of key stakeholders.
? Expectation and objectives setting and effectively obtains team commitment by communicating
the requirements to the project teams.
? Ensures study/project timelines and budgets are met in accordance to the contract agreement.
? Timeline changes are managed proactively and communicated with all project team’s members
to ensure the efficiencies are maximized.
? Ensure first time quality on deliverables from CTSL team to any other party.
? Address and follow up on Quality issues and implement CAPAs.
? Coordinates development of required CTSL study documents and systems according to given
project timelines and resources
? Work with the Logistics Project Specialist, Project Specialist and Project Leader, on developing
a project plan including all elements listed in the project plan template as appropriate for the
project (Roles and Responsibilities, WBS, Project Schedule, Communication Plan, Risk
Analysis, etc.).
? Mitigation and contingency planning
? Ensure that study specific management tools and Central File Maintenance plan are in place for
CTSL.
? Initiate project related training for project team members in collaboration with the Logistic
Project Specialist and CRS Project Specialist if applicable
? In collaboration with the Logistic Project Specialist prepare, participate in and follow up on
audits/inspections
? Collaborate with project team on project close out activities including but not limited to
administrative and system close outs and to give input to lessons learned information
*Job Qualifications
Education
? Educated to B.A/ B.S. or Master degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health –related discipline, international trade, business administration or logistics.
? Or relevant work experience/degree
Language Skills
? English fluent, verbal and written.
? Local language skills (additional languages desired)
Minimum Work Experience
? Five years of pharmaceutical/Clinical research/consulting industry experience.
? Profund experience in clinical logistics or related field within the biopharmaceutical industry.
? Project management and/or significant team leadership experience
? Individuals should have a strong understanding of cross functional activities
? Profound multinational work experience.
企業(yè)簡介
公司簡介:
國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)助世界各國大藥廠從事新藥開發(fā)及臨床試驗的臨床研究委托機(jī)構(gòu)(Contract Research Organization)。
國際精鼎臨床試驗研究團(tuán)隊是由一群具有豐富跨國性臨床試驗經(jīng)驗及專業(yè)知識的精英所組成,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個國家,在CRO的領(lǐng)域里已是亞洲的領(lǐng)導(dǎo)先驅(qū)。預(yù)計2007年APEX服務(wù)版圖將再擴(kuò)及2個國家、4個服務(wù)據(jù)點,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)于市場的薪資福利、良好工作環(huán)境,期許同仁與公司一同成長,邁向未來。
主要服務(wù)項目:
? 新藥開發(fā)策略的擬定與計劃
? 國際臨床試驗規(guī)劃及整合
? 引薦、甄選試驗計劃主持人
? 受試者同意書之設(shè)計
? 人體試驗委員會之送審
? 最高衛(wèi)生主管機(jī)關(guān)之送審
? 臨床試驗護(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)辦理新藥查驗登記事務(wù)
? 中草藥及健康食品臨床試驗、法規(guī)咨詢及查驗登記
愿景(Vision):創(chuàng)造一個在亞太地區(qū)具有國際競爭力的最精良CRO團(tuán)隊。
發(fā)展使命(Mission):
1 爭取國際大藥廠委托,執(zhí)行符合國際水準(zhǔn)的跨國性臨床試驗。
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)品國際化。
3 以提升臨床試驗品質(zhì)為宗旨,拓展全球市場為目標(biāo),整合計算機(jī)及通訊科技,在國際上提供客戶兼具成本效益及效率的臨床試驗數(shù)據(jù)處理中心。
4 建立一個以亞洲人種高發(fā)生率疾病的基因數(shù)據(jù)庫,以提供國際性新藥研發(fā)機(jī)構(gòu)所須之基因信息,協(xié)助其縮短藥物開發(fā)時程,幷提高研發(fā)成功率。
福利制度:
.薪資:
1. 提供具競爭性之薪資(含車補(bǔ)及飯補(bǔ))
.保險類:
1. 社會保險(依照國家規(guī)定)及住房公積金
2. 團(tuán)體保險(包括壽險、意外暨醫(yī)療保險)
.制度類:
1. 學(xué)習(xí)發(fā)展計劃 (Learning & Development): 針對個別員工之專業(yè)及興趣,設(shè)計符合其個人之生涯規(guī)劃
2. 完整的教育訓(xùn)練:每年公司均針對所有員工,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,亦可申請調(diào)至海外各子公司
.請 / 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