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Study Manager 临床项目经理
20-35K/月上海市-上海/本科及以上/5-10年
黄女士1天前来过
葛兰素史克（中国）投资有限公司
职位详情
The Local Study Manager (LSM) is the lead role for within-country operational feasibility, planning and delivery of Phase I-IV clinical trials and epidemiological studies in a specific country or cluster of countries. They are accountable for within-country execution and delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs.
Their scope of work includes matrix leadership and project management of country and site-level activities including site management & monitoring activities within their assigned countries. The LSM serves as the operational point-of-contact between the central Study Delivery Lead and in-country operational staff aligned to study.
In all geographies it is recognized that the LSM is part of the local GSK community and collaborates closely with local medical staff (who are responsible for local medical and scientific elements of the study) as well as with Clinical Research Associates (CRA)/monitors and other in-country staff.
The Local Study Manager (LSM) is a Local Delivery Lead who has demonstrated complete mastery of the LSM position and possesses the expertise and seniority necessary to execute additional coordination activities at an above-country level across multiple countries and regions as required. A SrLSM is capable of and can be relied upon to execute all of the following:
• Has the skills, abilities and seniority necessary to manage the in-country operational activities associated with any type of clinical trial (prophylactic or immunotherapeutic studies as well as epidemiology and local studies)
• Has proven experience in managing the in-country activities associated with pivotal, Phase III and efficacy studies (the most complex studies) which are critical to company success
• Can manage the in-country operational activities for ＞1 studies of significant complexity simultaneously
• Can manage in-country operational activities of complex studies in complex environments
-- Multiple local vendor involvement (insourced/outsourced local staffing, third-party vendors supporting recruitment/retention activities, visiting nurses, call centers, mobile vaccination units, etc.)
-- Medical/clinical care setting complexity: complex patient populations in tertiary care hospital settings and academic research centers; patient populations and prescribing medical groups new to GSK Vaccines based on evolving vaccine indications; novel or unusual clinical care delivery settings
-- Difficult environments in less developed geographies where local infrastructure is absent/not fully developed and must be facilitated and risk-managed
-- Collaborative studies where non-GSK partners (government agencies including the military, non-governmental organizations, other manufacturers, etc.) have involvement in local study execution
--Number of clinical sites involved significantly greater than regional average
• Has responsibility for local budget spends significantly greater than regional average due to size and complexity of studies assigned
• Can in-country manage studies of high local subject volume (multiple thousands of subjects) requiring large numbers of clinical sites and/or high numbers of subjects per clinical site (subject density); can manage delivery of high subject volume studies requiring compressed recruitment timings (e.g. seasonal disease studies)
• Can develop and execute within-country operational plans to deliver non-standard projects and new indications
• Can serve in above-country capacity to coordinate across multiple countries within or across regions for large, multi-country studies when number of countries participating requires additional project management support
--represents multiple countries in discussions with Study Delivery Leader and ensures local/central communication flow for the countries represented
--through discussion with in-country LDL, understands issues in individual countries and works to ensure appropriate solutions are developed; ensures clear line-of-sight from country to study accountable Study Delivery Leader
--identifies operational trends across countries within their above-country scope; liaises with other Sr LDLs performing above-country coordinating role on study to analyze trends and develop recommendations for discussion with Study Delivery Leader
--supports the development and success of LDLs conducting within-country operational activities in these assigned countries by sharing knowledge, expertise and judgment in study-related issues
• Can preferentially be called upon to conduct activities (document review, user testing, etc.) on behalf of multiple countries/regions; qualified to represent the views of more than a single country/region in support of pan-regional efficiency
• Serve as coach and mentor to LSM staff in own country or in other countries/regions as required based on experience and skills in function
Their scope of work includes matrix leadership and project management of country and site-level activities including site management & monitoring activities within their assigned countries. The LSM serves as the operational point-of-contact between the central Study Delivery Lead and in-country operational staff aligned to study.
In all geographies it is recognized that the LSM is part of the local GSK community and collaborates closely with local medical staff (who are responsible for local medical and scientific elements of the study) as well as with Clinical Research Associates (CRA)/monitors and other in-country staff.
The Local Study Manager (LSM) is a Local Delivery Lead who has demonstrated complete mastery of the LSM position and possesses the expertise and seniority necessary to execute additional coordination activities at an above-country level across multiple countries and regions as required. A SrLSM is capable of and can be relied upon to execute all of the following:
• Has the skills, abilities and seniority necessary to manage the in-country operational activities associated with any type of clinical trial (prophylactic or immunotherapeutic studies as well as epidemiology and local studies)
• Has proven experience in managing the in-country activities associated with pivotal, Phase III and efficacy studies (the most complex studies) which are critical to company success
• Can manage the in-country operational activities for ＞1 studies of significant complexity simultaneously
• Can manage in-country operational activities of complex studies in complex environments
-- Multiple local vendor involvement (insourced/outsourced local staffing, third-party vendors supporting recruitment/retention activities, visiting nurses, call centers, mobile vaccination units, etc.)
-- Medical/clinical care setting complexity: complex patient populations in tertiary care hospital settings and academic research centers; patient populations and prescribing medical groups new to GSK Vaccines based on evolving vaccine indications; novel or unusual clinical care delivery settings
-- Difficult environments in less developed geographies where local infrastructure is absent/not fully developed and must be facilitated and risk-managed
-- Collaborative studies where non-GSK partners (government agencies including the military, non-governmental organizations, other manufacturers, etc.) have involvement in local study execution
--Number of clinical sites involved significantly greater than regional average
• Has responsibility for local budget spends significantly greater than regional average due to size and complexity of studies assigned
• Can in-country manage studies of high local subject volume (multiple thousands of subjects) requiring large numbers of clinical sites and/or high numbers of subjects per clinical site (subject density); can manage delivery of high subject volume studies requiring compressed recruitment timings (e.g. seasonal disease studies)
• Can develop and execute within-country operational plans to deliver non-standard projects and new indications
• Can serve in above-country capacity to coordinate across multiple countries within or across regions for large, multi-country studies when number of countries participating requires additional project management support
--represents multiple countries in discussions with Study Delivery Leader and ensures local/central communication flow for the countries represented
--through discussion with in-country LDL, understands issues in individual countries and works to ensure appropriate solutions are developed; ensures clear line-of-sight from country to study accountable Study Delivery Leader
--identifies operational trends across countries within their above-country scope; liaises with other Sr LDLs performing above-country coordinating role on study to analyze trends and develop recommendations for discussion with Study Delivery Leader
--supports the development and success of LDLs conducting within-country operational activities in these assigned countries by sharing knowledge, expertise and judgment in study-related issues
• Can preferentially be called upon to conduct activities (document review, user testing, etc.) on behalf of multiple countries/regions; qualified to represent the views of more than a single country/region in support of pan-regional efficiency
• Serve as coach and mentor to LSM staff in own country or in other countries/regions as required based on experience and skills in function
任职要求
无
薪资结构
无
其他信息
职能类别：临床运营管理
职位性质：全职
招聘人数：1
工作地点：
- 1 上海市-上海
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公司信息
葛兰素史克（中国）投资有限公司
- 上海
- 1000-9999人
- 生物制药
- 外企
- 不需要融资
我们的使命与雄心
葛兰素史克（GSK）是一家以“汇聚科学、技术与人才，合力超越，共克疾病”为使命的全球生物医药公司。
我们致力于在未来十年为25亿人的健康带来积极影响。我们对增长和跨越式绩效的新承诺，展现了我们对患者的远大抱负。同时我们也是一家能够助力杰出人才蓬勃发展、人尽其才的公司。
在中国，我们始终致力于帮助改善中国人民的健康、生活和未来。
我们在中国的分布
业务覆盖中国250多个城市和地区
5个区域中心：北京、上海、成都、广州、杭州
1个位于上海的全国商业营运中心
1所位于上海的研发中心
1所位于北京的传染病和公共卫生研究所
我们在中国的业务
疫苗：我们是中国市场领先的疫苗供应商，致力于提高疫苗对中国患者和消费者的可及性。我们的儿童及成人疫苗可预防多种疾病：带状疱疹疫苗、宫颈癌疫苗，以及包括成人及儿童两种剂型的乙肝病毒疫苗。
处方药：我们的处方药业务拥有丰富的创新和成熟的产品组合。在中国，我们目前专注于以下疾病领域：呼吸系统、肝炎、神经系统疾病、HIV/艾滋病，以及包括系统性红斑狼疮在内的免疫系统疾病和包括肺动脉高压、嗜酸性肉芽肿性多血管炎（EGPA） 在内的罕见病。
