Sr. Clinical Research Specialist招聘_美敦力中国有限公司最新招聘信息-猎才医药网

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职位描述： KEY ACCOUNTABILITIES:Establishes Study Timelines, Budget, Resource, Risk and Quality Plans synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures1). Develop study synopsis, protocol, feasibility conduct and all study specific documents and procedures2). Oversees project, protocol and site feasibility and determines site selection and patient allocation3). Based on project chart, prepare integrate project plan to set study timeline, budget, resource, quality and risk.a. Develops country level study timelines according to the result of protocol/site feasibilityb. Establish country-level recruitment strategy/planc. Develops budget plan, and forecasts using appropriate tools, ensures the study team has the appropriate resources to effectively deliver high quality studies on time and within budgetd. Develops resource plan according to sites and patients allocatione. Develops study communication plan and monitoring planf. In pre-market study, sets study drug management planManage the Delivery of Study Activities in Order to Meet Study Plans1). Generate clear work breakdown structure to make each study member understand his responsibility2). Ensure study progress is in accordance with baseline project timelinea. Is accountable for timely achievement of key study milestones(EC approval, site initiation, first patient first visit, last patient first visit, last patient last visit, data frozen, etc.)b. Prepare and conduct outsourcing vendor selection. Act as a key contact with outsourcing vendor for proposal, interview, evaluation and contract. Submit vendor evaluation form for final approvalc. Prepare proposed site lists and patient allocationd. Device management (pre-market trial):·Complete device rolling forecast within request leading time·Continuously review device status report and ensure its accuracye. Safety management:·Ensure SAE reporting to PI/EC according to regulatory timeline and procedure·Complete SAE reconciliation according to the timeframef. Propose the contents of the i***estigator meeting and assign respective responsibility in the meeting among study teamg. Review and approve study related contracts (with external vendors or with sites).h. Establish and update study country information in CTMSi. Chair regular project review meetings where study progress and quality issues could be discussed and resolvedj. Ensure to setup and maintain trial master file3). Supervise the conduct of the study is in accordance with quality plana. Ensure studies are performed in compliance with protocol, ICH-GCP guidelines, Medtronic SOPs, local operating guidelines and all applicable regulatory requirements and quality planb. Leads and/or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e., I***estigator Meetings, Monitor’s Workshops, and CRO training.)c. Monitor key risk indicators which have been identified in quality plan. Ensure patient safety and data quality concerns are escalated and resolved appropriately (e.g. non-compliance in monitoring visits or AE occurrence)d. Review information uploaded to CTMS and project tracking tools. Query and correct any deviation or incomplete informatione. Ensure monitoring reports are timely, reviewed and takes appropriate action for follow up on site issuesf. Conduct co-monitoring visits in align with quality plan or for cause during the study. Complete co-monitoring reports and supervise monitor to correctg. In case of any quality deviation or other issues, lead study team to identify the route cause and to make follow up actions until resolutionh. Draft any possible slides or posters in study training or results delivery, including the slides or posters presented at domestic or international conferences.4). Oversee the management of the studies budgeta. Ensure study expense is within reasonable variance of approved budgetb. Review medical study expense reports and SAP study expense reports. Ensure each payment is accurate and is timelyc. Supervise study expense to ensure its compliance with approved budgetd. In case of any variance during the study, adjust budget phasing at least quarterly, however reasonable explanation should be providede. Timely complete accrual form according to FA requirement5）Collaborate with different functions (QA, RA, legal, etc) and global organization and work on all aspects of study management.REQUIREMENTS:At least 5 years proven experience in clinical operationProject management experience preferredBachelor degree in biomedical/science discipline or aboveGood understanding and knowledge of GCP and clinical trial operation processes/ proceduresSelf-motivated and achievement drivenStrong self-management and communication skillsGood English in written and spokenDemonstrated ability to interact with different professional levels of the research communityAbility of influencing and negotiating at all levels to achieve team deliveryExcellent written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organizationDemonstrated ability to prioritize and manage multiple tasksStrong computer skills - experience using various computer applications including spreadsheets, email, word-processing softwareDomestic and International travel required 职能类别：临床研究员关键字：临床专员

公司信息

医疗科技生命所系美敦力是一家在全球居于领先地位的医疗技术公司，致力于为慢性病患者提供终身的解决方案。在过去的岁月里，美敦力已经为专业医务人员提供了医疗产品及治疗方案，每年帮助逾500万的患者改善了生活品质。美敦力的主要产品覆盖了以下领域：心脏起搏治疗，心律失常管理，冠脉和周围血管疾病等方面。公司多次被《财富》杂志评为100家最值得赞赏的公司之一，并位于该行业前列。同时，在《财富》杂志“100家***雇主”上榜上有名。因美敦力在中国的业务飞速发展，现诚聘人员，欢迎符合条件的优秀专业人才加入。美敦力公司为员工提供具有竞争力的薪资福利，完善的培训与职业发展计划。敬请有志人士在2周内准备中英文简历、近照及证件、证书复印件寄往本公司。（请在信封上注明申请岗位、业务种类及工作地点）非中介不收费。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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