<p>Industry Background</p><p>Healthcare industry experience required in any of the following: pharmaceuticals, medical devices, life sciences, or CRO.</p><p> </p><p>Project Context</p><p>This role supports a system replacement and integration project related to acquisition. The BA will work closely with clinical teams to gather business requirements, support system migration, and ensure compliant delivery.</p><p> </p><p>Key Responsibilities</p><ol><li>Business Partnering: Work closely with clinical teams and business stakeholders to conduct requirements gathering and gap analysis, translating business needs into clear IT requirements, requirement specifications, and business cases.</li><li>Requirements Management: Manage requirements intake, prioritization, and change control, ensuring full traceability.</li><li>System Replacement Support: Support system integration and replacement activities within the acquisition, including migration and implementation of clinical, regulatory, commercial, and quality systems (e.g., CRM, RIMS, DMS, QMS, TMS, LIMS).</li><li>Process Understanding: Understand drug development processes and the cell and gene therapy (CGT) lifecycles from patient enrollment, T-cell collection, viral vector manufacturing, and CAR-T product manufacturing through to infusion - and perform requirements analysis and solution design within CAR-T-specific business scenarios.</li><li>Compliant Delivery: Carry out system integration work in a GxP-regulated environment, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and CSV methodologies.</li><li>Data Integrity: Ensure the accuracy and integrity of GxP data and implement security protocols to protect sensitive information such as patient data.</li></ol><p> </p><p>Requirements</p><ol><li>Business analysis or IT project delivery experience in the healthcare industry (pharma / devices / life sciences / CRO);</li><li>Experience working directly with clinical teams;</li><li>Ability to translate business needs into IT requirements and requirement specifications, with strong requirements management and prioritization skills;</li><li>Familiarity with key clinical, regulatory, commercial, and quality systems (e.g., CRM, RIMS, DMS, QMS, TMS, LIMS);</li><li>Knowledge of GxP and CSV compliance requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5);</li><li>Strong cross-functional communication and collaboration skills.</li></ol><p> </p><p>Nice to Have</p><ol><li>Experience in cell and gene therapy (CAR-T);</li><li>Experience with system integration/replacement projects related to acquisitions;</li><li>Hands-on experience with data integrity and patient data security.</li></ol><p><em>By clicking 'apply', you give your express consent that Robert Half may use your personal information to process your job application and to contact you from time to time for future employment opportunities. For further information on how Robert Half processes your personal information and how to access and correct your information, please read the Robert Half privacy notice https://www.roberthalf.cn/en/privacy-statement. Please do not submit any sensitive personal data to us in your resume (such as government ID numbers, ethnicity, gender, religion, marital status or trade union membership) as we do not collect your sensitive personal data at this time.</em></p><hr /><p>点击"申请"，即表示您明确同意 Robert Half 可以使用您的个人信息来处理您的工作申请，并不时与您联系以获得未来的就业机会。 如需进一步了解 Robert Half 如何处理您的个人信息以及如何访问和更正您的信息，请阅读 Robert Half 隐私声明<a href="https://nam02.safelinks.protection.outlook.com/?url=https://www.roberthalf.cn/en/privacy-statement&amp;data=05|01|[email protected]|45960615caf741a897da08db12e2448b|16532572d5674d678727f12f7bb6aed3|0|0|638124535281002861|Unknown|TWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0=|3000|||&amp;sdata=txey6FkFkoVyheBOucHzeYO1yTcFywlr7N4oX7M8axY=&amp;reserved=0">https://www.roberthalf.cn/en/privacy-statement</a> 。请不要在您的简历中向我们提交任何敏感的个人数据（例如身份证号码、种族、性别、宗教、婚姻状况或工会会员身份），因为我们此时不收集您的敏感个人数据。</p><img src="https://counter.adcourier.com/dHJveS5zaGFuZy45MTg5MS4xMDkyMUByaGljbi5hcGxpdHJhay5jb20.gif">