Clinical Logistics Operation Leader (临床物
职位描述
职位要求:英语口语精通,物流专业背景,熟知物流整体流程,至少3年物流工作经验,药品运输物流经验优先。
*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.
企业简介
公司简介:
国际精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系协助世界各国大药厂从事新药开发及临床试验的临床研究委托机构(Contract Research Organization)。
国际精鼎临床试验研究团队是由一群具有丰富跨国性临床试验经验及专业知识的精英所组成,目前已成为亚洲地区规模最大、服务项目最完整之专业CRO公司,幷已在业界建立高品质的专业形象以及良好口碑。
APEX目前拥有超过300名的专业精英,服务遍及11个国家,在CRO的领域里已是亚洲的领导先驱。预计2007年APEX服务版图将再扩及2个国家、4个服务据点,人员也将扩增至500人。APEX重视与客户的承诺,更重视人才的培育和养成,我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境,期许同仁与公司一同成长,迈向未来。
主要服务项目:
新药开发策略的拟定与计划
国际临床试验规划及整合
引荐、甄选试验计划主持人
受试者同意书之设计
人体试验委员会之送审
最高卫生主管机关之送审
临床试验护理专员
临床研究数据处理
向亚洲地区卫生主管机关办理新药查验登记事务
中草药及健康食品临床试验、法规咨询及查验登记
愿景(Vision):创造一个在亚太地区具有国际竞争力的最精良CRO团队。
发展使命(Mission):
1 争取国际大药厂委托,执行符合国际水准的跨国性临床试验。
2 协助亚太生技及制药产业建立新药开发模式,以提升产品研发能力,幷促使产品国际化。
3 以提升临床试验品质为宗旨,拓展全球市场为目标,整合计算机及通讯科技,在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。
4 建立一个以亚洲人种高发生率疾病的基因数据库,以提供国际性新药研发机构所须之基因信息,协助其缩短药物开发时程,幷提高研发成功率。
福利制度:
.薪资:
1. 提供具竞争性之薪资(含车补及饭补)
.保险类:
1. 社会保险(依照国家规定)及住房公积金
2. 团体保险(包括寿险、意外暨医疗保险)
.制度类:
1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣,设计符合其个人之生涯规划
2. 完整的教育训练:每年公司均针对所有员工,提供完整之教育训练
3. 顺畅的升迁管道及可转调其它部门;如有职缺,亦可申请调至海外各子公司
.请 / 休假制度:
1. 服务第一年即享有9天特休, 后续年休假天数则依据服务年资及公司制度而定
2. 一年可享4天不扣薪病假
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职位发布日期: 2015-09-21