
國際臨床項目管理

職位描述
工作職責(zé):
Duties and Responsibilities:
? Responsible and accountable for one or more clinical trial(s).
? Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).
? Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
? Responsible for effective communication within the Clinical Project Team and with functional management.
? Provides regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)
? Manages the project(s) within the approved budgets and timelines.
? Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework.
? Prepares investigational site lists and participates in reviewing and approving investigational sites.
? Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves various support system specifications (e.g. IVRS, etc.).
? Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.
? Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
? Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.
? Prepares and presents the status of the clinical project(s) to the Clinical Management Board.
? Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
? Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable MicroPort SOPs and policies.
? Represent the company at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings.
? Participate in external and internal audits/inspections, as required
任職資格:
Competency Expectations:
Ability to understand strategic goals and match the business needs of the company. Ability to develop good interpersonal relationships with medical professionals. Good verbal and written communication and presentation skills. Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies. Ability to independently manage and provide significant tactical and leadership guidance to clinical team. Independently motivated. Demonstrated ability to manage multiple projects, complex projects and international projects.
Working Conditions:
General office environment, approximately 10-30% travel to research laboratory or hospital settings, meetings and other MicroPort facilities. Potential exposure to blood borne pathogens and other potentially infectious materials
企業(yè)簡介
上海微創(chuàng)醫(yī)療器械(集團(tuán))有限公司為中國領(lǐng)先的醫(yī)療器械開發(fā)商、制造商及營銷商,主要專注于治療血管疾病及病變的微創(chuàng)介入產(chǎn)品。集團(tuán)于2010年9月于香港聯(lián)合交易所上市,股份編號:00853。
集團(tuán)主要供應(yīng)心血管器械和其他血管器械以及糖尿病器械,主要產(chǎn)品為第二代鈷鉻合金藥物洗脫支架 Firebird 2。集團(tuán)還供應(yīng)其他血管支架,用于治療身體其他部位的血管疾病及失調(diào)。集團(tuán)亦銷售極其細(xì)小的顱內(nèi)支架、用于促進(jìn)腦血管血液流量的靈活支架以及外科手術(shù)中使用的覆膜支架。
微創(chuàng)的產(chǎn)品于中國有逾1,100家醫(yī)院使用,部分產(chǎn)品出口至中國境外的20多個位于亞太地區(qū)(不包括中國)、南美及歐洲的國家。
有冠脈藥物支架系統(tǒng)、冠脈金屬支架系統(tǒng)、顱內(nèi)動脈支架系統(tǒng)、腹主動脈瘤和胸主動脈瘤等支撐型人造血管支架、球囊(PTCA)擴(kuò)張導(dǎo)管、導(dǎo)引導(dǎo)管及其相關(guān)附件、胰島素泵、骨科產(chǎn)品、射頻消融電生理導(dǎo)管等醫(yī)療器械;它們中絕大多數(shù)填補(bǔ)國內(nèi)空白,被認(rèn)定為上海市高新技術(shù)成果轉(zhuǎn)化項目,達(dá)國際先進(jìn)水平,直接與國外產(chǎn)品競爭,已進(jìn)入中國各大知名醫(yī)院,并出口日本、歐洲、拉美等國家與地區(qū),具有一定的品牌知名度和市場占有率。
職位發(fā)布企業(yè)
上海微創(chuàng)骨科醫(yī)療科技有限公司
企業(yè)性質(zhì):外資企業(yè)
企業(yè)規(guī)模:1-49人
成立年份:2009
企業(yè)網(wǎng)址:www.szbode.com
企業(yè)地址:1
該企業(yè)其他職位更多>>
相關(guān)職位推薦
上海相關(guān)職位: 銷售經(jīng)理(新生兒、醫(yī)療) 銷售經(jīng)理(呼吸醫(yī)療) 工藝員 微生物檢驗員 維系保養(yǎng)員/電工 (MJ002499) QA體系專員 驗證專員/主管 QC化學(xué)分析員 (MJ002498) QA質(zhì)量管理員(體系/驗證/注冊)
熱門區(qū)域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
上海招聘企業(yè): 上海拓康方舟醫(yī)療科技有限公司 易葫蘆(上海)醫(yī)藥科技有限公司 百進(jìn)冠合(海南) 醫(yī)療科技有限公司 上海華茂藥業(yè)有限公司 上海信誼藥廠有限公司 上海強(qiáng)生制藥 歐姆龍健康醫(yī)療(中國)有限公司 青海瑞成藥業(yè)(集團(tuán))有限公司 上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院 復(fù)旦大學(xué)附屬中山醫(yī)院
職位發(fā)布日期: 2019-05-16

