临床研究Clinician/Clinician Manager
3.5-6万
 上海-浦东新区
 无需经验
 硕士
 全职
 更新于05-26
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职位信息

ClinicalTrials
Co-chairs clinical study team and works collaboratively with other study team members.
Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
Through application of Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.
Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members)
Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.
Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.
Responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
Reviews and manages protocol deviations.
Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
Site Liaison Responsibilities (if applicable)
The China Clinician may have site liaison responsibilities:
Serve as clinical site liaison to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of Pfizer’ at each site. Create and maintain positive relationships and enthusiasm.
Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.
Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successfulsubject recruitment/enrollment/retention, protocol compliance and clinical trial quality.
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Conduct frank discussions and set clear expectations for site performance and monitor site performance throughmetrics.
Identify quality issues and discuss with Pfizer clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically-qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member.
Identify the need for and provide supportive coaching and/or training to site staff, as appropriate.
Education
61Required: BA/BS or equivalent qualification.
61Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduatetraining/certification /fellowship in a medical discipline or in drug development. Demonstratedscientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
Experience
61Preferred: Thorough understanding of local / international regulations applicable to clinical trials(pre and post approval). Practical experience in clinical trial strategies, methods and processes.Track record of design, oversight and interpretation of clinical studies. Previous leadership /management experience or training.
61Required: Knowledge and experience in Good Clinical Practices. Experience in conduct andexecution of clinical trials, including operational feasibility, recruitment, investigator performance,investigative site relations.
工作地址
 新梅联合广场B座9楼
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公司信息
精鼎医药(Parexel International)是全球领先的药物研究合同委托机构(CRO),总部位于美国生物医药圣地马萨诸塞州的波士顿附近,在世界各地拥有71个办事处,约17,600 名员工,为超过100个国家的客户提供服务。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
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img精鼎医药研究开发(上海)有限公司
外资(欧美)
10000人以上
制药/生物工程
这个有截止日期吗
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