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Clinical Research Supervisor | [查看更多类似职位] |
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工作地点 |
上海 |
发布日期 |
2008-05-12 |
工作年限 |
5年经验 |
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薪水范围 |
面议 | 学历要求 | 本科 |
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| 职位描述 |
职位类别： 生物/制药/医疗器械 工作地点： 上海 发布日期： 2008-04-09 工作经验： 5-10年 最低学历： 本科 管理经验： 是 工作性质： 全职 招聘人数： 若干 职位月薪： 10001-15000元/月 职位描述/要求： Main Tasks: Duties and responsibilities which are subject to periodic updating include: 1.LTM and/or Monitor for CDP/local trials conducted in CRO -Management and implementation of all aspects of clinical trials from trial set up to end of trial, including drafting protocol,CRF,monitor"s manual and all other trial related documents. -Collaborate with monitor in site selection and to ensure timely trial initiation, recruitment and closure. -Co-monitoring with monitor to ensure quality of trial performance. -Managing and controlling of local trial budgets Monitoring trial progress,instituting monitors/investigator training and taking any correction actions as and when necessary. -Liaising with RTM for all trial related issues and reports trial progress timely. -Maintaining up-to-date knowledge of trial issues. -Coaching and guiding local monitor to achieve targets within an assigned local/CDP trial. -Providing input to project team to optimize contribution of clinical trial participation to global development strategies. 2.Regional Trial Manager for CDP trials allocated to IOCDC. -Management and implementing clinical trials from trial set up to end of trial,including liaising closely with ITM and LTMs. -Providing information and advice to ITM, LTMs to ensure smooth running of the assigned CDP trial with optimal quality and speed. Representing IOCDC in project meeting to facilitate communication between HQ and IOCDC LTMs and monitors. -Tracking progress, status and performance of assigned CDP trial. -Ensuring that mandatory data are recorded and updated in IMPACT. -Organsing and conducting project, investigator and monitor meetings as required. -Ensuring accuracy of meeting minutes by circulating for review and distribution to team members. -Ensuring professional collaboration among all team members including ITM, IMO, CSCo, LTMs, and monitors, DM, STAT and MW by facilitating cross departmental work and communications. -Maintaining up-to-date knowledge of trial issues. Managing and monitoring trial budgets, taking corrective action and providing feedback to LTMs when necessary. -Co-monitoring with LTMs and/or monitors for the assigned CDP trial -Reviewing team"s reports and provide input to guide team towards achievement of deliverables. -Providing input during DBR and Patient Classification Meeting. -Giving input to the final ICTR. -Coaching and guiding LTMs and monitors to achieve targets by providing or recommending training where necessary and sharing experience and knowledge -Overall assessment and follow-up of team"s performance and deliverables after closure of project. -Providing input to IOCDC management team to optimize contribution of clinical development programs to business development strategies. 3.Representing IOCDC in global committee. -Attending meetings regularly. -Providing input from IOCDC to respective committee. -Addressing issues with IOCDC implications and participation in the committee. 4.Clinical Quality Assurance. -Liaising with CQTM in overall trial and system quality assurance by performing or giving input in. Co-monitoring. Trial site and affiliate office compliance check. TMF review. System compliance check. -Identifying trends of deficiencies from above initiatives and formulate necessary training as preventive action. -Maintaining up to date knowledge by attending relevant quality training 5.Supporting CRO clinical research team organization and development -Supporting CRO clinical research manager"s routine works, including but not limited to project feasibility analysis, projecting planning and status update, people assignment and arrangement, budget planning and cost tracking, expenses report approval etc. -To provide constructive and valuable suggestions to clinical research manager and medical management team which will benefit to the team and department development. -To set up the responsible clinical project team, provide coaching/ training/ target setting/performance review/leave approval/ to team members under CRM"s supervision. 6.Any other responsibilities and duties which may be required from time to time. Qualifications: -Bachelor"s degree or above of Medical Science. -Rich working experience in conducting clinical trials, at least 5 years experiences in clinical research field including 2-3 years international/global studies experiences. -Good communication skills and project achievements to be proved in previous working experiences. -Fluency English on both written&verbal. Working position:Shanghai 、Beijing 、Guangzhou 联系方式： .
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