1. 根據(jù)中心總體規(guī)劃目標(biāo)，組建項目運營與質(zhì)量管理部門，并組織開展業(yè)務(wù)工作；
2. 負(fù)責(zé)組織制定中心臨床運營、項目管理、臨床監(jiān)察、質(zhì)量保證和質(zhì)量控制等臨床研究實施各環(huán)節(jié)的工作制度、規(guī)章、操作標(biāo)準(zhǔn)等規(guī)范，并監(jiān)督實施；
3. 組織對部門人員進(jìn)行專業(yè)培訓(xùn)、指導(dǎo)與考核，參與部門人員招聘；
4. 協(xié)調(diào)與各臨床研究中心的合作關(guān)系，保持與各中心的主要研者進(jìn)行良性的互動；與涉及的藥政法規(guī)監(jiān)管部門，醫(yī)學(xué)領(lǐng)域?qū)＜?、科研院所等相關(guān)部門，建立并保持交流和溝通的渠道；
5. 完成上級交辦的其他工作。
1. Develop and lead the Project Operations & Quality Management Department.
2. Formulate and implement regulations, operation standards, and quality assurance processes for clinical research.
3. Provide training and guidance for the department’s personnel and lead recruitment efforts.
4. Build strong collaborative relationships with clinical research centers, regulatory bodies, and industry experts.

1. 專業(yè)經(jīng)驗：在制藥企業(yè)或臨床CRO公司至少10年臨床運營、臨床監(jiān)察或相關(guān)工作經(jīng)驗，3年部門管理的工作經(jīng)驗，廣泛的醫(yī)院網(wǎng)絡(luò)資源，熟悉臨床試驗運營；
2. 教育背景：臨床醫(yī)學(xué)、臨床藥學(xué)、藥事管理等相關(guān)專業(yè)碩士或以上學(xué)歷；
3. 政策法規(guī)：熟悉國內(nèi)國際藥械監(jiān)管的法律法規(guī)，及臨床試驗流程；
4. 語言能力：具備在英語環(huán)境下勝任崗位職責(zé)的能力；
5. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
1. 10+ years of experience in clinical operations or monitoring within pharmaceutical companies or CROs.
2. 3+ years of experience in departmental management with strong hospital network resources.
3. Master’s degree or above in Clinical Medicine, Clinical Pharmacy, or related fields.
4. Familiar with both domestic and international regulations governing clinical trials and drugs/ medical devices development.
5. Fluent in English with strong cross-cultural communication skills.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

應(yīng)聘材料
個人中文或英文簡歷(PDF)