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工作地點(diǎn)：中國(guó)廣州 （可適當(dāng)出差）
Work Location ： GuangZhou City，China / Occasional Business Travel required
崗位概述
該崗位負(fù)責(zé)公司臨床工作整體管理與推進(jìn)，具備扎實(shí)的醫(yī)學(xué)背景（職業(yè)醫(yī)師，精神科執(zhí)業(yè)醫(yī)師優(yōu)先），同時(shí)有豐富的臨床招募管理、項(xiàng)目執(zhí)行、團(tuán)隊(duì)管理經(jīng)驗(yàn)。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(yàn)的順利進(jìn)行。
主要工作職責(zé) Key responsibilities
1.臨床項(xiàng)目管理 / Clinical Project Management
1.1全面公司臨床項(xiàng)目試驗(yàn)的設(shè)計(jì)、實(shí)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(xiàng)目計(jì)劃、時(shí)間表和預(yù)算，并確保達(dá)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(tuán)隊(duì)與客戶、醫(yī)院等相關(guān)機(jī)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(biāo)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(hù)臨床試驗(yàn)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(rèn)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(zhǔn)確性，并符合試驗(yàn)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(jìn)度及質(zhì)量，及時(shí)優(yōu)化流程。
Monitor recruitment progress and quality, and promptly optimize processes when necessary.
3. 醫(yī)學(xué)與科學(xué)支持 / Medical and Scientific Support
3.1提供醫(yī)學(xué)專業(yè)意見(jiàn)，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(xué)問(wèn)題，培訓(xùn)團(tuán)隊(duì)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(píng)估及醫(yī)學(xué)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(xiàng)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(fù)責(zé)應(yīng)對(duì)監(jiān)管機(jī)構(gòu)及倫理委員會(huì)的溝通與檢查。 Manage communications and inspections with regulatory authorities and ethics committees
5. 團(tuán)隊(duì)建設(shè)與領(lǐng)導(dǎo) / Team Building and Leadership
5.1管理并培養(yǎng)臨床運(yùn)營(yíng)團(tuán)隊(duì)，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(jìn)行績(jī)效評(píng)估。 Set KPIs and conduct performance evaluations.
1.醫(yī)學(xué)碩士及以上學(xué)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.