Country Study Manager (外派全球大药厂）招聘_精鼎医药研究开发（上海）有限公司最新招聘信息-猎才医药网

职位描述

职位描述： As a Country Study Manager, you will be responsible for:Throughout the Study Lifetime:Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget.Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from a local CCO perspective (Global Studies).Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies), if apply.Coaches, and provides indirect line management support in partnership with the relevant line managers to Sponsor in-house study team members (i.e. Country Study Specialist (CSS) and Study Start Up Specialist (SSUS)) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Sponsor Vendor Manager and CRO Management regarding feedback on CRO staff performance.Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up.Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost).Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, i***estigator/site development activities etcStudy Preparation Phase:Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both within Clinical Operations and externally contribute appropriately.Provides support and expertise for regulatory, ethical and administrative submissions.Accountable for ensuring i***estigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies.Accountable for the development of the local CCO’s study budget, initial study resourcing forecasts and establishment of study level plans.Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready by ensuring there are regular quality checks on the completeness and robustness of study related documents.Study Conduct Phase:In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate Sponsor planning system. Highlights deviations in plans to relevant parties, develops and implements mitigation strategies as required.Develops and maintains effective working relationships, including being the key point of contact where appropriate, with key internal and external stakeholders, including i***estigators, local medical team, global study team, other local departments, external vendors/CROs etc.In conjunction with local Head of Clinical Operations, Therapeutic Area Leader (TAL) and/or Medical Manager (MM) or the Country Medical Director (CMD), ensures relationships with key i***estigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.Study Close-Out:Ensures all activities related to site/study close-out are managed according to global and local processes.Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities.You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.Qualification:Education and relevant working experience: University degree or equivalent in a medical/science-related field and/or 5 years proven experience in Clinical Research/Development or related industry.Skills, Experience and Competencies:Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studiesProject Management: including implementation of risk management plans and management of complex study budgets and resourcing plansCommunication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organizationPersonal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.Good knowledge of ICH GCP, GPP, Sponsor SOPs/Guidelines and quality standards related to study management.Clear and accurate communication in written and spoken English.Strong computer skills.Clinical development experience on the operational aspects of conducting clinical studies including:vendor/CRO resource managementleading/working as part of a development teamimplementing clinical development plansrisk managementcoordinating study level activities to deliver data for filing or publication purposes including interaction with local Business UnitsDemonstrated ability to interact with different professional levels of the research communityExperience of influencing and negotiating at all levels to achieve team delivery 职能类别：生物工程/生物制药临床研究员

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，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。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。公司福利和人才培养计划：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）； 3. 补充医疗保险；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14天年假, 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12天不扣薪病假； 3. 员工旅游, 年度体检；精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。应聘方法： 1. 在线投递； 2. 请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs）我们在收到您的简历之后，会尽快与您联系。谢谢！

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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