Clinical Logistics Operation Leader (臨床物
職位描述
職位要求:英語口語精通,物流專業背景,熟知物流整體流程,至少3年物流工作經驗,藥品運輸物流經驗優先。
*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,系協助世界各國大藥廠從事新藥開發及臨床試驗的臨床研究委托機構(Contract Research Organization)。
國際精鼎臨床試驗研究團隊是由一群具有豐富跨國性臨床試驗經驗及專業知識的精英所組成,目前已成為亞洲地區規模最大、服務項目最完整之專業CRO公司,幷已在業界建立高品質的專業形象以及良好口碑。
APEX目前擁有超過300名的專業精英,服務遍及11個國家,在CRO的領域里已是亞洲的領導先驅。預計2007年APEX服務版圖將再擴及2個國家、4個服務據點,人員也將擴增至500人。APEX重視與客戶的承諾,更重視人才的培育和養成,我們提供完整的教育訓練、職涯規劃、優于市場的薪資福利、良好工作環境,期許同仁與公司一同成長,邁向未來。
主要服務項目:
? 新藥開發策略的擬定與計劃
? 國際臨床試驗規劃及整合
? 引薦、甄選試驗計劃主持人
? 受試者同意書之設計
? 人體試驗委員會之送審
? 最高衛生主管機關之送審
? 臨床試驗護理專員
? 臨床研究數據處理
? 向亞洲地區衛生主管機關辦理新藥查驗登記事務
? 中草藥及健康食品臨床試驗、法規咨詢及查驗登記
愿景(Vision):創造一個在亞太地區具有國際競爭力的最精良CRO團隊。
發展使命(Mission):
1 爭取國際大藥廠委托,執行符合國際水準的跨國性臨床試驗。
2 協助亞太生技及制藥產業建立新藥開發模式,以提升產品研發能力,幷促使產品國際化。
3 以提升臨床試驗品質為宗旨,拓展全球市場為目標,整合計算機及通訊科技,在國際上提供客戶兼具成本效益及效率的臨床試驗數據處理中心。
4 建立一個以亞洲人種高發生率疾病的基因數據庫,以提供國際性新藥研發機構所須之基因信息,協助其縮短藥物開發時程,幷提高研發成功率。
福利制度:
.薪資:
1. 提供具競爭性之薪資(含車補及飯補)
.保險類:
1. 社會保險(依照國家規定)及住房公積金
2. 團體保險(包括壽險、意外暨醫療保險)
.制度類:
1. 學習發展計劃 (Learning & Development): 針對個別員工之專業及興趣,設計符合其個人之生涯規劃
2. 完整的教育訓練:每年公司均針對所有員工,提供完整之教育訓練
3. 順暢的升遷管道及可轉調其它部門;如有職缺,亦可申請調至海外各子公司
.請 / 休假制度:
1. 服務第一年即享有9天特休, 后續年休假天數則依據服務年資及公司制度而定
2. 一年可享4天不扣薪病假
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職位發布日期: 2015-09-21