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工作地點：中國廣州 （可適當出差）
Work Location ： GuangZhou City，China / Occasional Business Travel required
崗位概述
該崗位負責公司臨床工作整體管理與推進，具備扎實的醫(yī)學背景（職業(yè)醫(yī)師，精神科執(zhí)業(yè)醫(yī)師優(yōu)先），同時有豐富的臨床招募管理、項目執(zhí)行、團隊管理經(jīng)驗。需具備優(yōu)秀的英文交流及跨文化溝通能力，以支持全球/多中心臨床試驗的順利進行。
主要工作職責 Key responsibilities
1.臨床項目管理 / Clinical Project Management
1.1全面公司臨床項目試驗的設(shè)計、實施與質(zhì)量監(jiān)控的全面工作
Oversee the full scope of the company’s clinical trial design, implementation, and quality monitoring.
1.2制定項目計劃、時間表和預算，并確保達成關(guān)鍵里程碑。
Develop project plans, timelines, and budgets, ensuring the achievement of key milestones.
1.3協(xié)調(diào)內(nèi)部團隊與客戶、醫(yī)院等相關(guān)機構(gòu)的合作；
Coordinate collaboration between internal teams and stakeholders such as clients, hospitals,
and other relevant institutions.
2. 臨床受試者招募管理 / Clinical Patient Recruitment Management
2.1制定并執(zhí)行受試者招募策略，確保招募目標按期完成。
Develop and implement patient recruitment strategies to ensure enrollment targets are met on schedule.
2.2建立與維護臨床試驗中心、醫(yī)生、患者組織的良好合作關(guān)系。
Establish and maintain strong relationships with clinical trial sites, investigators, and patient organizations.
2.3核查和確認受試者入組條件與入組記錄，確保所有入組信息的完整性與準確性，并符合試驗方案及相關(guān)倫理、法規(guī)要求
Review and verify subject enrollment eligibility and records to ensure completeness and accuracy of all enrollment information, in compliance with the study protocol and applicable ethical and regulatory requirements. Communicate with relevant teams as needed to promptly correct or supplement information.
2.4 監(jiān)控招募進度及質(zhì)量，及時優(yōu)化流程。
Monitor recruitment progress and quality, and promptly optimize processes when necessary.
3. 醫(yī)學與科學支持 / Medical and Scientific Support
3.1提供醫(yī)學專業(yè)意見，參與研究方案、知情同意書等核心文件的撰寫與審核。
Provide medical expertise and participate in the drafting and review of core documents such as study protocols
and informed consent forms.
3.2 解答研究相關(guān)的醫(yī)學問題，培訓團隊成員與研究中心人員。
Address medical questions related to the study and deliver training to team members and site staff.
3.3 參與安全性事件評估及醫(yī)學決策。
Participate in the assessment of safety events and contribute to medical decision-making.
4. 合規(guī)與質(zhì)量保證 / Compliance and Quality Assurance
4.1 確保項目遵循ICH-GCP、相關(guān)法律及倫理要求。
Ensure that projects comply with ICH-GCP, relevant laws, and ethical requirements.
4.2 負責應對監(jiān)管機構(gòu)及倫理委員會的溝通與檢查。 Manage communications and inspections with regulatory authorities and ethics committees
5. 團隊建設(shè)與領(lǐng)導 / Team Building and Leadership
5.1管理并培養(yǎng)臨床運營團隊，提升專業(yè)能力與執(zhí)行力。 Build, manage, and develop the clinical operations team to enhance professional competence and execution capabilities.
制定KPI并進行績效評估。 Set KPIs and conduct performance evaluations.
1.醫(yī)學碩士及以上學歷，執(zhí)業(yè)醫(yī)師，職業(yè)醫(yī)師，精神科執(zhí)業(yè)醫(yī)師優(yōu)先 。 Master’s degree or higher in Medicine; licensed medical practitioner, with preference given to those qualified in Psychiatry.