COD

面议

上海市

刷新时间：2022-05-19

职位描述

  Primary Responsibilities:
Collarboration and Communication
Key contact person for CRO and vendors in assigned studyDevelop and maintain relationships with prioritized institutions and investigators in assigned studiesFacilitates investigator site communications (e.g., newsletter, enrollment updates)Support Project Lead on strategic site development and partnershipsStudy contact for Inspection ReadinessPropose innovative solutions to optimize processesspan> Business Deliverables
Accountable for study timeline, quality and budget plan and delivery.Provide input into study related vendors selection, such as vendors for CRO, recruitment, lab,etc., review and approve vendor payments, oversight vendor deliveries.Provide input into contract negotiation with clinical sites and vendors. Provide input into key study document delivery, including but not limited to ICF, trial issue management, project plan, enrollment plan, contract template and sample management plan. Provide operational strategic input to early protocol development and study timelinesLead CRO to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participationCoordinate and facilitate study training planning and implementationResponsible for site activation process, timeline, risk management, contract budget approval & controlActively coordinates, participates and presents in AST, ISST and/or SIVs as requiredCoordinate and facilitate enrollment readiness including all study set-up activities, NMPA study information online registration and HGRAO submission in preparation for FPV Oversights monitoring intervals, SDV/SDR backlog and site compliances
Monitoring oversight including sampling review monitoring visit reports and meeting with vendors.Co-ordinate and conduct study based co-monitoring with CRAs as requiredAccountable for study issue management and protocol deviation reviewOversight of study timeline, SDV status and data query resolution as plannedVerify and approve site paymentLead and ensure site self check process within planned timeCreate and maintain study system such as eTMF with completeness and high qualityOversee site level TMFs to ensure completeness, accuracy and updated in a timely mannerCollaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow upIdentify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolutionspan>pan> Regulations and Compliance
Responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelinesResponsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and ProceduresFacilitate site audit and inspection activities from clinical operation perspective Maintains familiarity with regulations and guidelines regarding study execution practices
Minimum Qualification Requirements:
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At least Bachelor’s degree or equivalent work experience in a scientific or health-related field
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Minimum of 5 years’ CRA or 2 years’ country study manger or similar position working experience in Clinical Trials
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Project management skills
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Strong problem solving and communication skills (both verbal and written)
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Good computer Microsoft office software skills
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Need to travel periodically to ISST, comonitoring activities and potentially other scientific/regional meetings  

其他要求

招聘人数：1人
职能类别：临床总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。