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KEY ACCOUNTABILITIES:As CPL:
1.For clinical trials劸Participates in the assessment of the trial feasibility劸Makes a selection of investigators劸Prepares the file submission To the Health Authorities To the Ethical Committee劸Prepares the investigatorsˇ contracts.劸Prepares the clinical trial AED劸Writes / validates the technical and/or administrative documents which are necessary for the trial and makes the Corporate documents fit the local regulations.劸Organises the local investigators meetings when appropriate.劸Ensures the good initiation of the centers, especially makes sure that the investigators are perfectly informed of the trial specificities and of its organisation.劸Ensures a good follow
-up of the centers, i.e. By co
-monitoring visits勏By assessing the monitoring reports勏By following the recruitment.劸Participates locally to the setting up of the audits carried out by the Corporate ; coordinates the answers and follows up the possible correcting actions. 劸Ensures an efficient liaison with designated IP support .劸Checks the payment of the investigators fees.劸Ensures that tolerance items are collected and reported.劸Makes sure that centers are properly closed :勏Files archiving勏IP and trial material collection.劸Keeps informed the investigators and the Health Authorities/ Ethical Committee of the trialˇs results.劸Ensures the update of CTMS.
2.CRU劸Participates in the allocation of trials within the CRU.劸Trains the CRAs to the studyˇs specificities.劸Coordinates the activity of the CRAs working on the study (centers allocation, workload) 劸Cares for the implementation of the studyˇs instructions. 劸Ensures the setting up of the studyˇs file inside the CRU.劸Informs the CRU Director of the progress of the trial and of the difficulties encountered, makes a review with him of the adequate strategy to be set up.
3.Corporate team劸Makes sure that the International Clinical Development receives all required data on the trial progress.劸Participates in the meetings related to the trial and organised by the International Clinical Development.As MA:刋Assess the feasibility of international protocols in his /her country by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders or potential investigators according to International Clinical Development (ICD) requirements and timing. First
-line medical support to the CRU team e.g : answer medical questions from investigating sites, answer questions from Ethics Committees. Ensure scientific training to the monitoring team. Maintain and expand the investigator network in his/her country. Promote participation of the country in early phase studies (I and IIa) Contribute to the exchange of relevant information between R&D and Medico Marketing department regarding clinical activity of the CRU and support the handover of R and D products to marketed compounds. Support the affiliate network of KOL when selecting National Coordinators or members of study committees. CRU preferred point of contact for ICD to provide input on Clinical Development Plan and medical practices (e.g. review of synopsis).JOB
-HOLDER ENTRY REQUIREMENTS:Education:Minimum bachelor degree in clinical medicine or pharmacyExperience & knowledge: Previous experience in monitoring clinical trails is requiredCore competencies: Good command of English ( written and spoken)Knowledge of PC (WORD, EXCEL, POWERPOINT)Interpersonal communication skillTeam player
赛诺菲安万特集团是世界领先的专业制药公司。集团拥有世界级的研发机构,20个研究中心的11000名科学家致力于研究和开发创新的治疗方案,研究主要涉及心血管,血栓,肿瘤,中枢神经系统,糖尿病,内科和疫苗等多个领域。 赛诺菲安万特在中国的运营总部位于上海,旗下拥有三家合资工厂,员工约2200人。 依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源,公司在中国的市场份额不断攀升,公司规模不断扩大,飞速发展的业务给了我们与更多优秀人才合作的机会。 公司切实致力于员工的激励和个人职业生涯的发展。 公司除了为应聘者提供具有竞争力的薪酬和福利,同时把对一线员工的职业发展付诸实践。 2005年起,公司启动了致力于发现一线销售人才并培养其成为一线经理人的特别计划,已有许多一线销售精英成为全国各地的销售经理,踏上成就个人理想的道路。 2007年1月,公司颁布了员工职业发展计划,为员工在公司内部的发展指明了道路,近40名经过专业培训的职业顾问分布在全国各地,为员工职业发展给予专业的指导。为了配合员工的职业发展计划,2007年2月,公司成立了赛诺菲安万特大学,来自全国各地的新老员工都将有机会在全新的课堂里接受专业的培训。 伴随公司业绩的大幅成长,千余名销售代表在05和06年分别获得赴澳洲和法国的旅行奖励,分享团队成功的体验。 在这个充满生机的团队中,你的字典里没有“不可能”----加入我们,去迎接激动人心的挑战!您可以开阔地预见自己的职业生涯――切勿固步自封;我们需要的专业并非如你所想,因为,我们对专业有着独到的理解,那就是热情,是主动,是创造;您也不用再为那些“专业经验”之类的招聘广告感到迷惑,你不是孤军奋战,因为你的背后,是一个行业的巨擎给予的坚实支持! 现在就行动!把握机遇,加入我们,中国最高速发展的医药公司之一,您的职业生涯将与公司共同成长!抓住机会,来亲身体验我们所秉持的胆略,创新,团结和勇气的价值观。 请将中英文简历、一寸近照、身份证、学历证书复印件寄至或传真至公司各办事处(请务必在信封和简历上注明应聘职位及工作城市) 或发简历至本公司。 请您不要重复投递简历!