临床试验医生，研究领域 科室不限，有上市前临床试验相关经验者优先。
Job title: Clinician
Job description:
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 successful subject 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 through metrics.
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. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific 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 and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.
职位名称：临床医师
职位描述：
临床研究领导：
共同主持临床研究团队
负责一个或多个临床研究（或其部分）的设计、实施、解释和报告
为临床试验策略和方案制定提供临床和科学专业知识
方案开发：
设计和撰写临床试验大纲、方案和修正案
与内部和外部专家合作
应用增强型临床试验设计（ECTD）和增强型定量药物开发（EQDD）原则
研究监督：
创建并交付临床/方案培训材料
建立和监督数据监测委员会（DMCs）和终点裁定委员会
共同负责研究入组和遵守商定的时间表
研究中心管理：
与研究中心保持直接联系
履行研究中心联络职责（如适用）
通过虚拟和面对面互动支持试验实施
安全监测：
审查个体和累积安全数据
识别新出现的安全趋势
管理方案偏差
质量保证：
确保高质量的数据收集
识别并解决研究中心的质量问题
教育和经验要求：
教育：
必需：学士学位或同等学历
优先：高级学位（医学博士、博士、兽医博士、硕士或药学博士）
经验：
必需：了解良好临床实践（GCP）并具有临床试验实施经验
优先：了解当地/国际临床试验法规，具有临床试验策略实践经验和领导经验
这个角色需要结合临床专业知识、研究经验、领导技能和对临床试验过程的深入了解。临床医师在确保临床研究的成功设计、执行和监督，同时保持高标准的安全性和质量方面发挥着关键作用。
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